Trial Outcomes & Findings for Pulsed Electromagnetic Fields for Post-Amputation Pain (NCT NCT05392803)
NCT ID: NCT05392803
Last Updated: 2024-09-19
Results Overview
The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will be the difference between the baseline and Day 28 timepoints.
COMPLETED
NA
14 participants
Baseline and Day 28
2024-09-19
Participant Flow
Participant milestones
| Measure |
Active Intervention (30 Days), Washout (7 Days), Sham Intervention (30 Days)
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy, 7 day "washout", 30 days of sham intervention.
|
Sham Intervention (30 Days), Washout (7 Days), Active Intervention (30 Days)
Application of 30 days of a nonfunctional sham device, 7 day "washout", then 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Active Intervention (30 Days), Washout (7 Days), Sham Intervention (30 Days)
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy, 7 day "washout", 30 days of sham intervention.
|
Sham Intervention (30 Days), Washout (7 Days), Active Intervention (30 Days)
Application of 30 days of a nonfunctional sham device, 7 day "washout", then 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Then Sham Treatment
n=7 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy, 7 day "washout", 30 days of sham.
Active then Sham Treatment: Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy; then sham treatment after a 7-day "washout" period
|
Sham Then Active Treatment
n=7 Participants
Application of 30 days of a nonfunctional sham device, 7 day "washout", then 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
Sham then Active Treatment: Application of 30 days of sham treatment; then 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy after a 7-day "washout" period
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 14 • n=7 Participants
|
61 years
STANDARD_DEVIATION 22 • n=7 Participants
|
59 years
STANDARD_DEVIATION 18 • n=14 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=14 Participants
|
|
Height
|
180 cm
STANDARD_DEVIATION 9 • n=7 Participants
|
172 cm
STANDARD_DEVIATION 9 • n=7 Participants
|
176 cm
STANDARD_DEVIATION 9 • n=14 Participants
|
|
Weight
|
84 kg
STANDARD_DEVIATION 21 • n=7 Participants
|
69 kg
STANDARD_DEVIATION 18 • n=7 Participants
|
76 kg
STANDARD_DEVIATION 20 • n=14 Participants
|
|
Body Mass Index
|
26 kg/m^2
STANDARD_DEVIATION 6 • n=7 Participants
|
23 kg/m^2
STANDARD_DEVIATION 4 • n=7 Participants
|
24 kg/m^2
STANDARD_DEVIATION 5 • n=14 Participants
|
|
Trans-Femoral amputation
|
3 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=14 Participants
|
|
Trans-Tibial amputation
|
4 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=14 Participants
|
|
Continuous phantom limb pain at baseline
|
6 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=14 Participants
|
|
Continuous residual limb pain at baseline
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 28The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will be the difference between the baseline and Day 28 timepoints.
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in Average RESIDUAL Limb Pain Scores Between Baseline and Day 28 of the Initial Treatment as Measured With the Numeric Rating Scale
|
2.5 score on a scale
Interval 2.5 to 2.8
|
0 score on a scale
Interval -0.5 to 0.0
|
PRIMARY outcome
Timeframe: Baseline and Day 28The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will be the difference between the baseline and Day 28 timepoints.
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in Average PHANTOM Limb Pain Scores Between Baseline and Day 28 of the Initial Treatment as Measured With the Numeric Rating Scale
|
2.3 score on a scale
Interval 1.8 to 3.5
|
0 score on a scale
Interval -0.3 to 0.0
|
PRIMARY outcome
Timeframe: Day 28A 7-point Likert scale with 1 equivalent to "much worse", 4 equivalent to "no change", and 7 equivalent to "much improved". Patients compare their current pain level with baseline using this scale.
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Patient Global Impression of Change for RESIDUAL Limb Pain Between Baseline and Day 28 of the Initial Treatment
|
7 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
PRIMARY outcome
Timeframe: Day 28A 7-point Likert scale with 1 equivalent to "much worse", 4 equivalent to "no change", and 7 equivalent to "much improved". Patients compare their current pain level with baseline using this scale.
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Patient Global Impression of Change for PHANTOM Limb Pain Between Baseline and Day 28 of the Initial Treatment
|
6.5 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Days 2, 4, 7, 21, 28, and 35A 7-point Likert scale with 1 equivalent to "much worse", 4 equivalent to "no change", and 7 equivalent to "much improved". Patients compare their current pain level with baseline using this scale.
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Patient Global Impression of Change for RESIDUAL Limb Pain
Day 2
|
4 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 4.0 to 5.0
|
|
Patient Global Impression of Change for RESIDUAL Limb Pain
Day 4
|
5 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Global Impression of Change for RESIDUAL Limb Pain
Day 7
|
5 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.5
|
|
Patient Global Impression of Change for RESIDUAL Limb Pain
Day 21
|
7 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Global Impression of Change for RESIDUAL Limb Pain
Day 28
|
7 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Global Impression of Change for RESIDUAL Limb Pain
Day 35
|
4 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Days 2, 4, 7, 21, 28, and 35A 7-point Likert scale with 1 equivalent to "much worse", 4 equivalent to "no change", and 7 equivalent to "much improved". Patients compare their current pain level with baseline using this scale.
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Patient Global Impression of Change for PHANTOM Limb Pain
Day 2
|
5 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Global Impression of Change for PHANTOM Limb Pain
Day 4
|
5 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 3.5 to 4.0
|
|
Patient Global Impression of Change for PHANTOM Limb Pain
Day 7
|
6.5 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.3
|
|
Patient Global Impression of Change for PHANTOM Limb Pain
Day 21
|
6.5 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.5
|
|
Patient Global Impression of Change for PHANTOM Limb Pain
Day 28
|
6.5 score on a scale
Interval 4.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Global Impression of Change for PHANTOM Limb Pain
Day 35
|
4 score on a scale
Interval 4.0 to 6.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Days 2, 4, 7, 21, 28, and 35The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the difference between the baseline and current pain level measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in AVERAGE RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 2
|
2.5 score on a scale
Interval 1.3 to 3.8
|
4 score on a scale
Interval 2.0 to 5.0
|
|
Change in AVERAGE RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 4
|
3 score on a scale
Interval 1.4 to 3.8
|
4 score on a scale
Interval 4.0 to 6.0
|
|
Change in AVERAGE RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 7
|
2 score on a scale
Interval 1.0 to 3.3
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Change in AVERAGE RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 21
|
1.3 score on a scale
Interval 0.8 to 3.1
|
4 score on a scale
Interval 4.0 to 4.5
|
|
Change in AVERAGE RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 28
|
1.5 score on a scale
Interval 0.8 to 2.5
|
4 score on a scale
Interval 4.0 to 4.5
|
|
Change in AVERAGE RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 35
|
1.5 score on a scale
Interval 1.0 to 4.0
|
4 score on a scale
Interval 4.0 to 5.5
|
SECONDARY outcome
Timeframe: Days 2, 4, 7, 21, 28, and 35The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the difference between the baseline and current pain level measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in WORST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 2
|
3.5 score on a scale
Interval 3.0 to 5.5
|
5 score on a scale
Interval 3.0 to 7.0
|
|
Change in WORST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 4
|
3 score on a scale
Interval 2.5 to 6.5
|
5 score on a scale
Interval 5.0 to 9.0
|
|
Change in WORST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 7
|
3 score on a scale
Interval 2.3 to 5.0
|
5 score on a scale
Interval 5.0 to 6.0
|
|
Change in WORST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 21
|
3 score on a scale
Interval 1.5 to 5.0
|
5.5 score on a scale
Interval 5.0 to 7.0
|
|
Change in WORST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 28
|
3 score on a scale
Interval 1.5 to 5.0
|
5.5 score on a scale
Interval 5.0 to 6.5
|
|
Change in WORST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 35
|
4 score on a scale
Interval 2.3 to 6.5
|
5 score on a scale
Interval 4.5 to 7.0
|
SECONDARY outcome
Timeframe: Days 28 and 35The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the difference between the baseline and current pain level measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in LEAST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 28
|
0 score on a scale
Interval 0.0 to 0.0
|
3.5 score on a scale
Interval 0.0 to 6.0
|
|
Change in LEAST RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 35
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 0.5
|
SECONDARY outcome
Timeframe: Days 28 and 35The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the difference between the baseline and current pain level measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in CURRENT RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 28
|
0 score on a scale
Interval 0.0 to 2.0
|
4 score on a scale
Interval 3.0 to 4.0
|
|
Change in CURRENT RESIDUAL Pain From Baseline Measured With the Numeric Rating Scale
Day 35
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Days 2, 4, 7, 21, 28, and 35The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the difference between the baseline and current pain level measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in AVERAGE PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 2
|
4.5 units on a scale
Interval 1.5 to 5.8
|
3 units on a scale
Interval 2.3 to 3.5
|
|
Change in AVERAGE PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 4
|
4 units on a scale
Interval 2.3 to 5.0
|
3.5 units on a scale
Interval 3.0 to 4.0
|
|
Change in AVERAGE PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 7
|
2 units on a scale
Interval 1.1 to 5.6
|
4 units on a scale
Interval 3.3 to 5.8
|
|
Change in AVERAGE PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 21
|
2 units on a scale
Interval 0.0 to 4.6
|
4 units on a scale
Interval 3.0 to 5.3
|
|
Change in AVERAGE PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 28
|
2 units on a scale
Interval 0.0 to 4.3
|
4 units on a scale
Interval 3.8 to 5.5
|
|
Change in AVERAGE PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 35
|
2.5 units on a scale
Interval 1.5 to 4.5
|
4 units on a scale
Interval 3.9 to 4.8
|
SECONDARY outcome
Timeframe: Days 2, 4, 7, 21, 28, and 35The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the difference between the baseline and current pain level measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in WORST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 2
|
6 score on a scale
Interval 4.3 to 7.0
|
5 score on a scale
Interval 3.8 to 7.0
|
|
Change in WORST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 4
|
4.7 score on a scale
Interval 1.8 to 7.4
|
6.5 score on a scale
Interval 4.5 to 10.0
|
|
Change in WORST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 7
|
3.5 score on a scale
Interval 1.5 to 7.3
|
5 score on a scale
Interval 4.5 to 7.8
|
|
Change in WORST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 21
|
3.5 score on a scale
Interval 1.0 to 5.1
|
5 score on a scale
Interval 3.0 to 8.3
|
|
Change in WORST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 28
|
3.5 score on a scale
Interval 0.9 to 7.3
|
6 score on a scale
Interval 4.5 to 9.3
|
|
Change in WORST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 35
|
5 score on a scale
Interval 3.8 to 8.0
|
5.5 score on a scale
Interval 4.8 to 7.0
|
SECONDARY outcome
Timeframe: Days 28 and 35The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the difference between the baseline and current pain level measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in LEAST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 28
|
0 units on a scale
Interval 0.0 to 3.6
|
0 units on a scale
Interval 0.0 to 1.5
|
|
Change in LEAST PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 35
|
0 units on a scale
Interval 0.0 to 3.7
|
1 units on a scale
Interval 0.0 to 3.3
|
SECONDARY outcome
Timeframe: Days 28 and 35The numeric rating scale is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain scale. The outcome will the difference between the baseline and current pain level measured with the Numeric Rating Scale
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Change in CURRENT PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 28
|
3 score on a scale
Interval 1.0 to 4.5
|
3 score on a scale
Interval 0.0 to 4.0
|
|
Change in CURRENT PHANTOM Pain From Baseline Measured With the Numeric Rating Scale
Day 35
|
3.5 score on a scale
Interval 0.8 to 4.8
|
4 score on a scale
Interval 3.0 to 4.8
|
SECONDARY outcome
Timeframe: Inquired on Day 2, 4, 7, 21, 28 and 35 for both initial and crossover treatmentsPopulation: This outcome was inadvertently left off the case report forms, and therefore no data was collected for this outcome
Patient's perception of requirements over the previous 24 hours of as-needed (non-scheduled) analgesic use
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Inquired on Days 28 and 35The Brief pain Inventory (short form) is an instrument specifically designed to assess pain and its impact on physical and emotional functioning. The brief Inventory is comprised of three domains: (1) pain, with four questions involving "worst", "average" and "current" pain levels using a 0-10 numeric rating scale \[we are not using\]; (2) percentage of relief provided by pain treatments with one question \[we are not using\] and, (3) interference with 7 questions involving physical and emotional functioning using a 0-10 Likert scale \[0=no interference (good); 10=complete interference (bad)\]: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. This outcome will include the interference subscale: 0=no interference (good); 70=complete interference (bad)
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Brief Pain Inventory, Short Form (Interference Sub Scale)
Day 28
|
19.7 score on a scale
Standard Deviation 20.4
|
20.9 score on a scale
Standard Deviation 5.2
|
|
Brief Pain Inventory, Short Form (Interference Sub Scale)
Day 35
|
34 score on a scale
Standard Deviation 26
|
28 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: Inquired on Days 2, 4, 7, 21, 28, and 35The number of awakenings due to pain that occurred the previous evening
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Awakenings Due to Pain the Previous Evening
Day 2
|
0 number of awakenings
Standard Deviation 0
|
.1 number of awakenings
Standard Deviation .4
|
|
Awakenings Due to Pain the Previous Evening
Day 4
|
.6 number of awakenings
Standard Deviation .9
|
1.9 number of awakenings
Standard Deviation 3.7
|
|
Awakenings Due to Pain the Previous Evening
Day 7
|
.4 number of awakenings
Standard Deviation .9
|
.1 number of awakenings
Standard Deviation .4
|
|
Awakenings Due to Pain the Previous Evening
Day 21
|
0 number of awakenings
Standard Deviation 0
|
.1 number of awakenings
Standard Deviation .4
|
|
Awakenings Due to Pain the Previous Evening
Day 28
|
.4 number of awakenings
Standard Deviation .9
|
.3 number of awakenings
Standard Deviation .8
|
|
Awakenings Due to Pain the Previous Evening
Day 35
|
.4 number of awakenings
Standard Deviation .9
|
2.6 number of awakenings
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Inquired on Day 35Does the patient want to continue using device answered as "yes" or "no". "Yes" means they DO want to continue using the device, while "no" means they do NOT want to continue using the device.
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Does Patient Want to Continue Using Device (Participants Answering "Yes")?
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Inquired on Days 2, 4, 7, 21, 28 and 35If a patient moves the anatomic location of one or both of the intervention devices (and where the device is moved to) since the last contact
Outcome measures
| Measure |
Active Treatment
n=12 Participants
Application of 30 days of nonthermal, pulsed shortwave (radiofrequency) therapy
|
Sham Treatment
n=14 Participants
Application of 30 days of a nonfunctional sham device
|
|---|---|---|
|
Device Location Changes
Day 7
|
1 Participants
|
0 Participants
|
|
Device Location Changes
Day 2
|
0 Participants
|
0 Participants
|
|
Device Location Changes
Day 4
|
1 Participants
|
0 Participants
|
|
Device Location Changes
Day 21
|
0 Participants
|
0 Participants
|
|
Device Location Changes
Day 28
|
0 Participants
|
0 Participants
|
|
Device Location Changes
Day 35
|
0 Participants
|
0 Participants
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Adverse Events
Active
Sham
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian Ilfeld, MD, MS
University of California San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place