Trial Outcomes & Findings for Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID) (NCT NCT03204825)
NCT ID: NCT03204825
Last Updated: 2025-10-06
Results Overview
Maximal walking distance on graded treadmill test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)
Results posted on
2025-10-06
Participant Flow
The trial was open for recruitment between August 2017 and March 2020. In total, 1030 people were screened for eligibility; 763 (74%) were ineligible, mainly because they were on the clinic lists due to other conditions e.g., Abdominal Aortic Aneurysm or venous disease (n=343, 45% of ineligible total) or had Critical Limb Ischaemia (CLI) (n=122, 16%). There were 172 individuals that either did not consent to participate or did not respond to invitation.
Participants underwent additional screening prior to randomisation in adherence with the inclusion criteria in the protocol. Thirty-nine participants did not pass screening, 38 (97%) due to having a greater than 20% variance in ACD between the first and second screening visits (one week apart). The other participant who did not pass screening was unable to walk on the treadmill.
Participant milestones
| Measure |
Active TENS
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
14
|
|
Overall Study
End of Intervention
|
12
|
11
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
10
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 9.7 • n=14 Participants
|
69.1 years
STANDARD_DEVIATION 10.1 • n=14 Participants
|
64.0 years
STANDARD_DEVIATION 5.5 • n=14 Participants
|
66.9 years
STANDARD_DEVIATION 8.3 • n=14 Participants
|
66.3 years
STANDARD_DEVIATION 8.6 • n=56 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
1 Participants
n=14 Participants
|
4 Participants
n=14 Participants
|
5 Participants
n=14 Participants
|
14 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
13 Participants
n=14 Participants
|
10 Participants
n=14 Participants
|
9 Participants
n=14 Participants
|
42 Participants
n=56 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
56 participants
n=56 Participants
|
|
Body Mass Index
|
26.4 kg/m^2
STANDARD_DEVIATION 4.7 • n=14 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 3.9 • n=14 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 5.5 • n=14 Participants
|
29.4 kg/m^2
STANDARD_DEVIATION 4.3 • n=14 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 4.8 • n=56 Participants
|
|
Ankle Brachial Pressure Index
|
0.70 Ratio of systolic BP - UL / LL
STANDARD_DEVIATION 0.21 • n=14 Participants
|
0.74 Ratio of systolic BP - UL / LL
STANDARD_DEVIATION 0.28 • n=14 Participants
|
0.67 Ratio of systolic BP - UL / LL
STANDARD_DEVIATION 0.15 • n=14 Participants
|
0.66 Ratio of systolic BP - UL / LL
STANDARD_DEVIATION 0.14 • n=14 Participants
|
0.69 Ratio of systolic BP - UL / LL
STANDARD_DEVIATION 0.20 • n=56 Participants
|
|
Initial Claudication Distance (ICD)
|
84.4 Metres
STANDARD_DEVIATION 78.2 • n=14 Participants
|
126.1 Metres
STANDARD_DEVIATION 165.2 • n=14 Participants
|
130.2 Metres
STANDARD_DEVIATION 129.6 • n=14 Participants
|
111.7 Metres
STANDARD_DEVIATION 162.3 • n=14 Participants
|
113.1 Metres
STANDARD_DEVIATION 135.7 • n=56 Participants
|
|
Absolute Claudication Distance (ACD)
|
243.7 Metres
STANDARD_DEVIATION 240.5 • n=14 Participants
|
251.3 Metres
STANDARD_DEVIATION 266.5 • n=14 Participants
|
370.9 Metres
STANDARD_DEVIATION 285.3 • n=14 Participants
|
318.4 Metres
STANDARD_DEVIATION 321.6 • n=14 Participants
|
296.1 Metres
STANDARD_DEVIATION 277.3 • n=56 Participants
|
|
Average daily number of steps ('000s)
|
7.5 Steps per day
STANDARD_DEVIATION 7.1 • n=14 Participants
|
4.9 Steps per day
STANDARD_DEVIATION 2.1 • n=14 Participants
|
6.0 Steps per day
STANDARD_DEVIATION 2.8 • n=14 Participants
|
5.1 Steps per day
STANDARD_DEVIATION 3.9 • n=14 Participants
|
5.9 Steps per day
STANDARD_DEVIATION 4.4 • n=56 Participants
|
|
Average daily number of upright events
|
7.0 Count
STANDARD_DEVIATION 2.9 • n=14 Participants
|
6.1 Count
STANDARD_DEVIATION 2.7 • n=14 Participants
|
6.6 Count
STANDARD_DEVIATION 2.9 • n=14 Participants
|
6.1 Count
STANDARD_DEVIATION 1.8 • n=14 Participants
|
6.4 Count
STANDARD_DEVIATION 2.5 • n=56 Participants
|
|
Average daily number of walking events
|
50.0 Count
STANDARD_DEVIATION 24.0 • n=14 Participants
|
50.2 Count
STANDARD_DEVIATION 21.2 • n=14 Participants
|
53.6 Count
STANDARD_DEVIATION 26.0 • n=14 Participants
|
46.4 Count
STANDARD_DEVIATION 19.1 • n=14 Participants
|
50.0 Count
STANDARD_DEVIATION 22.2 • n=56 Participants
|
|
Event-based Claudication Index
|
7.3 Ratio
STANDARD_DEVIATION 2.8 • n=14 Participants
|
8.9 Ratio
STANDARD_DEVIATION 4.4 • n=14 Participants
|
8.4 Ratio
STANDARD_DEVIATION 4.3 • n=14 Participants
|
8.5 Ratio
STANDARD_DEVIATION 6.3 • n=14 Participants
|
8.3 Ratio
STANDARD_DEVIATION 4.6 • n=56 Participants
|
|
SF-36 Physical Component Score
|
34.4 units on a scale
STANDARD_DEVIATION 7.5 • n=14 Participants
|
32.5 units on a scale
STANDARD_DEVIATION 8.9 • n=14 Participants
|
37.3 units on a scale
STANDARD_DEVIATION 5.2 • n=14 Participants
|
38.1 units on a scale
STANDARD_DEVIATION 6.0 • n=14 Participants
|
35.6 units on a scale
STANDARD_DEVIATION 7.2 • n=56 Participants
|
|
SF-36 Mental Component Score
|
23.9 units on a scale
STANDARD_DEVIATION 11.3 • n=14 Participants
|
22.7 units on a scale
STANDARD_DEVIATION 11.7 • n=14 Participants
|
25.3 units on a scale
STANDARD_DEVIATION 12.7 • n=14 Participants
|
24.6 units on a scale
STANDARD_DEVIATION 13.9 • n=14 Participants
|
24.1 units on a scale
STANDARD_DEVIATION 12.2 • n=56 Participants
|
|
Intermittent Claudication Questionnaire
|
53.1 units on a scale
STANDARD_DEVIATION 16.0 • n=14 Participants
|
53.2 units on a scale
STANDARD_DEVIATION 15.7 • n=14 Participants
|
52.2 units on a scale
STANDARD_DEVIATION 15.4 • n=14 Participants
|
47.6 units on a scale
STANDARD_DEVIATION 16.0 • n=14 Participants
|
51.5 units on a scale
STANDARD_DEVIATION 15.5 • n=56 Participants
|
|
Geriatric Depression Scale (short-form)
|
6.6 units on a scale
STANDARD_DEVIATION 4.2 • n=14 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 3.9 • n=14 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 4.6 • n=14 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 4.7 • n=14 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 4.3 • n=56 Participants
|
|
McGill Pain Questionnaire
|
30.6 units on a scale
STANDARD_DEVIATION 13.6 • n=14 Participants
|
22.2 units on a scale
STANDARD_DEVIATION 13.1 • n=14 Participants
|
31.2 units on a scale
STANDARD_DEVIATION 14.4 • n=14 Participants
|
29.4 units on a scale
STANDARD_DEVIATION 10.6 • n=14 Participants
|
28.4 units on a scale
STANDARD_DEVIATION 13.1 • n=56 Participants
|
|
Pain Self-Efficacy Questionnaire
|
35.8 units on a scale
STANDARD_DEVIATION 13.7 • n=14 Participants
|
42.4 units on a scale
STANDARD_DEVIATION 14.3 • n=14 Participants
|
36.5 units on a scale
STANDARD_DEVIATION 14.8 • n=14 Participants
|
35.2 units on a scale
STANDARD_DEVIATION 13.9 • n=14 Participants
|
37.5 units on a scale
STANDARD_DEVIATION 14.1 • n=56 Participants
|
|
Pain intensity (visual analogue scale)
|
6.3 units on a scale
STANDARD_DEVIATION 2.3 • n=14 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 2.8 • n=14 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 2.4 • n=14 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 2.6 • n=14 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 2.5 • n=56 Participants
|
|
Brief Illness Perception Questionnaire
|
47.2 units on a scale
STANDARD_DEVIATION 11.9 • n=14 Participants
|
43.4 units on a scale
STANDARD_DEVIATION 10.1 • n=14 Participants
|
49.8 units on a scale
STANDARD_DEVIATION 9.7 • n=14 Participants
|
49.3 units on a scale
STANDARD_DEVIATION 10.4 • n=14 Participants
|
47.4 units on a scale
STANDARD_DEVIATION 10.6 • n=56 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Maximal walking distance on graded treadmill test
Outcome measures
| Measure |
Active TENS
n=12 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=11 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=13 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=13 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Change in Absolute Claudication Distance (ACD) in Meters From Baseline
Change scores from baseline to end of intervention (6 weeks)
|
-16.8 metres
Interval -62.1 to 28.4
|
-6.7 metres
Interval -33.8 to 20.5
|
76.2 metres
Interval 17.0 to 135.4
|
-0.9 metres
Interval -44.2 to 42.4
|
|
Change in Absolute Claudication Distance (ACD) in Meters From Baseline
Change scores from baseline to follow-up (18 weeks)
|
25.0 metres
Interval -26.8 to 76.7
|
-17.6 metres
Interval -41.0 to 5.8
|
89.2 metres
Interval 21.3 to 157.1
|
-15.1 metres
Interval -64.1 to 33.9
|
PRIMARY outcome
Timeframe: RecruitmentMeasure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log
Outcome measures
| Measure |
Active TENS
n=267 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Recruitment Rates
|
95 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: End of study (18 weeks)Ratio of patients who completed the intervention and outcome assessment to the patient who consented
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Participant Retention Rate
|
13 Participants
|
10 Participants
|
12 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: End of study (18 weeks)Record defined adverse events in all groups
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Adverse Events
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: End of study (18 weeks)Population: Population described as a whole rather than per-arm as data per arm was not recorded due to blinding. All participants were randomised to receive some type of TENS hence 56 total and 50% of participants received education, hence n=28.
Measure uptake of intervention via log of TENS use and attendance at education session and follow up phone calls
Outcome measures
| Measure |
Active TENS
n=56 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=28 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=28 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Uptake of Interventions
|
39 Participants
|
27 Participants
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Onset distance of claudication pain on graded treadmill test
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Change in Initial Claudication Distance (ICD) in Meters From Baseline
Change from baseline to end of intervention (6 weeks)
|
37.8 metres
Interval 5.9 to 69.8
|
23.2 metres
Interval -17.0 to 163.5
|
107.6 metres
Interval 37.3 to 178.0
|
52.2 metres
Interval 5.0 to 99.4
|
|
Change in Initial Claudication Distance (ICD) in Meters From Baseline
Change from baseline to follow-up (18 weeks)
|
55.2 metres
Interval -11.4 to 121.7
|
77.1 metres
Interval -83.4 to 237.5
|
122.7 metres
Interval 26.6 to 218.9
|
54.1 metres
Interval -3.9 to 112.1
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Change in daily number of steps (activpal step counts)
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Change in Daily Number of Steps
Change from baseline to end of intervention (6 weeks)
|
-1568 steps
Interval -3766.0 to 631.0
|
-237 steps
Interval -874.0 to 399.0
|
1076 steps
Interval -758.0 to 2910.0
|
442 steps
Interval -430.0 to 1314.0
|
|
Change in Daily Number of Steps
Change from baseline to follow-up (18 weeks)
|
-1942 steps
Interval -3239.0 to -646.0
|
-183 steps
Interval -1048.0 to 683.0
|
1615 steps
Interval -2425.0 to 5654.0
|
-1637 steps
Interval -4010.0 to 736.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Total number of upright events per day (activpal upright even count)
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Change in Total Number of Upright Events Per Day
Change from baseline to end of intervention (6 weeks)
|
-1.1 upright events per day
Interval -8.6 to 6.3
|
-2.3 upright events per day
Interval -6.9 to 2.4
|
-3.9 upright events per day
Interval -13.5 to 5.6
|
1.7 upright events per day
Interval -2.3 to 5.7
|
|
Change in Total Number of Upright Events Per Day
Change from baseline to follow-up (18 weeks)
|
-2.1 upright events per day
Interval -8.4 to 4.1
|
2.5 upright events per day
Interval -3.8 to 8.9
|
-4.7 upright events per day
Interval -9.2 to -0.2
|
-3.4 upright events per day
Interval -13.0 to 6.1
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Total number of walking events per day (activpal walking event counts)
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Change in Total Number of Walking Events Per Day
Change from baseline to end of intervention (6 weeks)
|
-27.7 events per day
Interval -88.4 to 33.0
|
-22.1 events per day
Interval -65.3 to 21.1
|
-27.6 events per day
Interval -106.1 to 50.8
|
16.3 events per day
Interval -46.1 to 78.6
|
|
Change in Total Number of Walking Events Per Day
Change from baseline to follow-up (18 weeks)
|
-53.5 events per day
Interval -99.6 to -7.4
|
0.1 events per day
Interval -75.8 to 76.1
|
-36.9 events per day
Interval -98.7 to 25.0
|
-39.4 events per day
Interval -107.6 to 28.8
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Event-based claudication index (ratio of walking events to upright events) participants undertake in a day.
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Change in Event-based Claudication Index
Change from baseline to end of intervention (6 weeks)
|
-0.4 calculated ratio index
Interval -1.2 to 0.3
|
-0.4 calculated ratio index
Interval -1.1 to 0.3
|
0.9 calculated ratio index
Interval -1.0 to 2.7
|
-0.2 calculated ratio index
Interval -1.1 to 0.7
|
|
Change in Event-based Claudication Index
Change from baseline to follow-up (18 weeks)
|
-1.2 calculated ratio index
Interval -2.5 to 0.1
|
-0.7 calculated ratio index
Interval -3.2 to 1.7
|
0.0 calculated ratio index
Interval -1.0 to 1.0
|
-0.6 calculated ratio index
Interval -1.0 to -0.2
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Disease specific quality of life questionnaire. ICQ scores range from 0 to 100, with lower scores representing better health status and less impact of claudication
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Intermittent Claudication Questionnaire (ICQ)
Change from baseline to end of intervention (6 weeks)
|
4.5 units on a scale
Interval -1.3 to 10.2
|
5.6 units on a scale
Interval 0.3 to 10.8
|
8.5 units on a scale
Interval 1.7 to 15.3
|
9.6 units on a scale
Interval 3.5 to 15.7
|
|
Intermittent Claudication Questionnaire (ICQ)
Change from baseline to follow-up (18 weeks)
|
4.4 units on a scale
Interval -0.4 to 9.2
|
2.3 units on a scale
Interval -3.9 to 8.5
|
9.3 units on a scale
Interval 1.9 to 16.8
|
8.0 units on a scale
Interval 3.2 to 12.7
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Generic quality of life questionnaire, physical domain. The SF-36 Physical Component Summary (PCS) ranges from 0-100, with higher scores representing better outcomes.
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Short-Form 36 Questionnaire- Physical Component
Change from baseline to end of intervention (6 weeks)
|
1.4 units on a scale
Interval -1.4 to 4.3
|
0.0 units on a scale
Interval -3.3 to 3.3
|
-5.2 units on a scale
Interval -8.5 to -1.8
|
-4.5 units on a scale
Interval -8.4 to -0.7
|
|
Short-Form 36 Questionnaire- Physical Component
Change from baseline to follow-up (18 weeks)
|
-0.6 units on a scale
Interval -3.4 to 2.2
|
1.0 units on a scale
Interval -2.6 to 4.6
|
-3.7 units on a scale
Interval -5.5 to -1.8
|
-3.3 units on a scale
Interval -7.2 to 0.7
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Pain quality questionnaire. The MPQ-PRI ranges from 0-78, with lower scores representing less pain and higher scores representing worse pain.
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
McGill Pain Questionnaire (MPQ) Pain Rating Index (PRI)
Change from baseline to end of intervention (6 weeks)
|
4.3 units on a scale
Interval -0.8 to 9.5
|
3.5 units on a scale
Interval -4.0 to 11.1
|
-5.9 units on a scale
Interval -9.9 to -1.9
|
-6.5 units on a scale
Interval -12.3 to -0.6
|
|
McGill Pain Questionnaire (MPQ) Pain Rating Index (PRI)
Change from baseline to follow-up (18 weeks)
|
2.5 units on a scale
Interval -1.3 to 6.3
|
2.6 units on a scale
Interval -2.4 to 7.6
|
-7.4 units on a scale
Interval -11.0 to -3.8
|
-3.0 units on a scale
Interval -8.1 to 2.1
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Average Pain intensity in the past 7 days. The average pain intensity VAS ranges from 0-100 mm, with lower scores indicating less pain and better outcomes.
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
Change from baseline to end of intervention (6 weeks)
|
-0.7 units on a scale
Interval -2.2 to 0.8
|
-1.0 units on a scale
Interval -2.4 to 0.3
|
-2.0 units on a scale
Interval -3.3 to -0.7
|
-1.5 units on a scale
Interval -3.1 to 0.0
|
|
Visual Analogue Scale (VAS)
Change from baseline to follow-up (18 weeks)
|
-1.2 units on a scale
Interval -2.7 to 0.2
|
-1.4 units on a scale
Interval -3.4 to 0.6
|
-1.8 units on a scale
Interval -3.1 to -0.4
|
0.1 units on a scale
Interval -1.4 to 1.6
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)The Brief IPQ uses 0-10 scales. Higher scores indicate worse perceptions (greater perceived consequences, concern, emotional impact, chronicity).
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Brief Illness Perception Questionnaire (IPQ)
Change from baseline to end of intervention (6 weeks)
|
-1.7 units on a scale
Interval -6.8 to 3.5
|
0.6 units on a scale
Interval -5.0 to 6.3
|
-7.7 units on a scale
Interval -12.8 to -2.5
|
-8.1 units on a scale
Interval -15.1 to -1.0
|
|
Brief Illness Perception Questionnaire (IPQ)
Change from baseline to follow-up (18 weeks)
|
-1.5 units on a scale
Interval -6.2 to 3.1
|
1.0 units on a scale
Interval -5.3 to 7.3
|
-3.2 units on a scale
Interval -8.9 to 2.4
|
-5.6 units on a scale
Interval -10.9 to -0.3
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)Depression questionnaire. The GDS-SF ranges 0-15, with higher scores reflecting more depressive symptoms.
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Geriatric Depression Scale (Short Form) (GDS-SF)
Change from baseline to end of intervention (6 weeks)
|
-1.5 units on a scale
Interval -3.3 to 0.2
|
-0.8 units on a scale
Interval -3.5 to 2.0
|
-1.8 units on a scale
Interval -4.0 to 0.3
|
-1.2 units on a scale
Interval -2.6 to 0.2
|
|
Geriatric Depression Scale (Short Form) (GDS-SF)
Change from baseline to follow-up (18 weeks)
|
-0.9 units on a scale
Interval -3.2 to 1.3
|
0.2 units on a scale
Interval -2.8 to 3.2
|
-2.2 units on a scale
Interval -4.8 to 0.4
|
-1.0 units on a scale
Interval -2.3 to 0.3
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks (post-intervention), 18 weeks (follow-up)The PSEQ total score ranges from 0-60, with higher scores indicating better pain self-efficacy and more positive outcomes.
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
Pain Self-Efficacy Questionnaire (PSEQ)
Change from baseline to end of intervention (6 weeks)
|
1.0 units on a scale
Interval -4.2 to 6.2
|
0.8 units on a scale
Interval -2.5 to 4.2
|
5.2 units on a scale
Interval -1.5 to 11.8
|
6.9 units on a scale
Interval 1.7 to 12.1
|
|
Pain Self-Efficacy Questionnaire (PSEQ)
Change from baseline to follow-up (18 weeks)
|
1.9 units on a scale
Interval -3.7 to 7.6
|
0.4 units on a scale
Interval -5.5 to 6.3
|
5.8 units on a scale
Interval -1.8 to 13.4
|
3.6 units on a scale
Interval -1.9 to 9.1
|
SECONDARY outcome
Timeframe: Baseline, end of intervention and follow-upSF-36 Quality of life scale - mental component. The SF-36 MCS ranges 0-100 (or norm-based mean 50, SD 10), with higher scores representing better outcomes.
Outcome measures
| Measure |
Active TENS
n=14 Participants
Participants in the TENS groups will be provided with a TENS machine and training at the baseline visit to the Clinical research Facility (CRF). They will be instructed to use it daily as their symptoms require for 6 weeks. The active group will receive High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
|
Placebo TENS
n=14 Participants
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective
|
Patient-Centred Education and Placebo TENS
n=14 Participants
Patient-Centred Education : a one-off three-hour workshop of structured group education (4-5 persons in each group) and three 2-weekly phone calls. The aim will be to modify patients' illness beliefs and perceptions about IC/PAD by educating them on disease pathology and management philosophy. After the workshop, each patient will be supported to set goals for walking, develop an action plan regarding how these goals will be met and encouraged to repeat this process for each new walking goal.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
Placebo TENS : Participants will receive the same model, programmed settings and instructions for use as those in the active group except that the device will be set to an ineffective stimulation (120 Hz, 200µs and a patient-determined intensity of '6mA). For the purpose of blinding, participants will be told that different dosages of TENS are being tested, some of which where the stimulation might not be perceivable even though the device is working.
Placebo TENS: TENS device use with setting so that the stimulation delivered is ineffective.
|
Patient-Centred Education + Active TENS
n=14 Participants
Combination of Patient-Centred Education arm and Active TENS arm.
Active TENS: TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
Patient-Centred Education: Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
|
|---|---|---|---|---|
|
SF-36 Mental Component Score
Change from baseline to end of intervention (6 weeks)
|
-2.8 units on a scale
Interval -7.6 to 2.0
|
0.5 units on a scale
Interval -5.9 to 7.0
|
-3.0 units on a scale
Interval -9.4 to 3.4
|
-1.8 units on a scale
Interval -6.8 to 3.2
|
|
SF-36 Mental Component Score
Change from baseline to follow-up (18 weeks)
|
-0.1 units on a scale
Interval -4.4 to 4.3
|
0.1 units on a scale
Interval -7.8 to 8.0
|
-2.7 units on a scale
Interval -7.2 to 1.7
|
-0.4 units on a scale
Interval -4.7 to 4.0
|
Adverse Events
Active TENS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo TENS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Patient-Centred Education + Active TENS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Patient-Centred Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active TENS
n=14 participants at risk
Active TENS group
|
Placebo TENS
n=14 participants at risk
Placebo TENS group
|
Patient-Centred Education + Active TENS
n=14 participants at risk
Patient-Centred Education + Active TENS group
|
Patient-Centred Education
n=14 participants at risk
Patient-Centred Education group
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching on leg due to TENS electrodes
|
7.1%
1/14 • Number of events 1 • 24 weeks
|
7.1%
1/14 • Number of events 1 • 24 weeks
|
7.1%
1/14 • Number of events 1 • 24 weeks
|
0.00%
0/14 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place