Trial Outcomes & Findings for Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) (NCT NCT01888640)
NCT ID: NCT01888640
Last Updated: 2019-10-31
Results Overview
Numeric rating scale of 0-10 (low to high scale) for pain with movement during six minute walk test; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS
Results posted on
2019-10-31
Participant Flow
Participant milestones
| Measure |
Active TENS
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
103
|
99
|
99
|
|
Overall Study
COMPLETED
|
76
|
68
|
94
|
|
Overall Study
NOT COMPLETED
|
27
|
31
|
5
|
Reasons for withdrawal
| Measure |
Active TENS
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
15
|
11
|
4
|
|
Overall Study
Minimum dose not met
|
10
|
16
|
0
|
|
Overall Study
Given wrong unit (placebo)
|
1
|
0
|
0
|
|
Overall Study
Excluded for prior TENS
|
0
|
1
|
0
|
|
Overall Study
Researcher Termination of Participant
|
0
|
1
|
1
|
Baseline Characteristics
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
Baseline characteristics by cohort
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
no TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
95 Participants
n=27 Participants
|
285 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 14.3 • n=93 Participants
|
47.2 Years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
48.6 Years
STANDARD_DEVIATION 11.8 • n=27 Participants
|
46.8 Years
STANDARD_DEVIATION 12.9 • n=483 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=93 Participants
|
99 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
301 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
276 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
262 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=93 Participants
|
99 participants
n=4 Participants
|
99 participants
n=27 Participants
|
301 participants
n=483 Participants
|
|
Pain with movement six minute walk test
|
6.5 0 to 10 low to high scale
STANDARD_DEVIATION 1.9 • n=93 Participants
|
6.2 0 to 10 low to high scale
STANDARD_DEVIATION 1.9 • n=4 Participants
|
6.4 0 to 10 low to high scale
STANDARD_DEVIATION 1.9 • n=27 Participants
|
6.4 0 to 10 low to high scale
STANDARD_DEVIATION 1.9 • n=483 Participants
|
|
Pain with movement five time sit to stand
|
5.8 0 to 10 low to high scale
STANDARD_DEVIATION 2.4 • n=93 Participants
|
5.5 0 to 10 low to high scale
STANDARD_DEVIATION 2.2 • n=4 Participants
|
5.6 0 to 10 low to high scale
STANDARD_DEVIATION 2.2 • n=27 Participants
|
5.6 0 to 10 low to high scale
STANDARD_DEVIATION 2.2 • n=483 Participants
|
|
Pain at rest
|
6.2 0 to 10 low to high scale
STANDARD_DEVIATION 1.5 • n=93 Participants
|
5.9 0 to 10 low to high scale
STANDARD_DEVIATION 1.4 • n=4 Participants
|
6.1 0 to 10 low to high scale
STANDARD_DEVIATION 1.6 • n=27 Participants
|
6.0 0 to 10 low to high scale
STANDARD_DEVIATION 1.5 • n=483 Participants
|
|
Fatigue at rest
|
6.8 0 to 10 low to high scale
STANDARD_DEVIATION 2.0 • n=93 Participants
|
6.1 0 to 10 low to high scale
STANDARD_DEVIATION 1.8 • n=4 Participants
|
6.4 0 to 10 low to high scale
STANDARD_DEVIATION 2.0 • n=27 Participants
|
6.43 0 to 10 low to high scale
STANDARD_DEVIATION 1.9 • n=483 Participants
|
|
Fibromyalgia Impact Questionnaire Revised - Pain
|
6.7 0 to 10 low to high scale
STANDARD_DEVIATION 1.8 • n=93 Participants
|
6.0 0 to 10 low to high scale
STANDARD_DEVIATION 1.6 • n=4 Participants
|
6.15 0 to 10 low to high scale
STANDARD_DEVIATION 1.8 • n=27 Participants
|
6.28 0 to 10 low to high scale
STANDARD_DEVIATION 1.7 • n=483 Participants
|
|
Fibromyalgia Impact Questionnaire Revised
|
59.2 Scoring 0 to 100 low to high scale
STANDARD_DEVIATION 16.8 • n=93 Participants
|
53.7 Scoring 0 to 100 low to high scale
STANDARD_DEVIATION 15.9 • n=4 Participants
|
55.6 Scoring 0 to 100 low to high scale
STANDARD_DEVIATION 16.0 • n=27 Participants
|
56.1 Scoring 0 to 100 low to high scale
STANDARD_DEVIATION 16.2 • n=483 Participants
|
|
Short Form 36 Physical Component Score
|
32.7 T-score mean of 50
STANDARD_DEVIATION 6.4 • n=93 Participants
|
33.3 T-score mean of 50
STANDARD_DEVIATION 6.2 • n=4 Participants
|
32.7 T-score mean of 50
STANDARD_DEVIATION 6.6 • n=27 Participants
|
32.9 T-score mean of 50
STANDARD_DEVIATION 6.4 • n=483 Participants
|
|
Short Form 36 Mental Health Component Score
|
38.7 T-score mean of 50
STANDARD_DEVIATION 10.0 • n=93 Participants
|
40.2 T-score mean of 50
STANDARD_DEVIATION 10.2 • n=4 Participants
|
39.5 T-score mean of 50
STANDARD_DEVIATION 10.6 • n=27 Participants
|
39.4 T-score mean of 50
STANDARD_DEVIATION 10.2 • n=483 Participants
|
|
Tampa Scale of Kinesiophobia
|
36.5 Scoring 17 to 68 low to high
STANDARD_DEVIATION 7.7 • n=93 Participants
|
37.1 Scoring 17 to 68 low to high
STANDARD_DEVIATION 8.0 • n=4 Participants
|
37.4 Scoring 17 to 68 low to high
STANDARD_DEVIATION 8.3 • n=27 Participants
|
37 Scoring 17 to 68 low to high
STANDARD_DEVIATION 8.0 • n=483 Participants
|
|
Six minute walk test (Feet)
|
1386 Feet
STANDARD_DEVIATION 323 • n=93 Participants
|
1358 Feet
STANDARD_DEVIATION 305 • n=4 Participants
|
1316 Feet
STANDARD_DEVIATION 318 • n=27 Participants
|
1353.3 Feet
STANDARD_DEVIATION 315 • n=483 Participants
|
|
Five time sit to stand
|
4.1 sit-to-stand repetitions/10 seconds
STANDARD_DEVIATION 1.5 • n=93 Participants
|
4.0 sit-to-stand repetitions/10 seconds
STANDARD_DEVIATION 1.4 • n=4 Participants
|
3.9 sit-to-stand repetitions/10 seconds
STANDARD_DEVIATION 1.5 • n=27 Participants
|
4.0 sit-to-stand repetitions/10 seconds
STANDARD_DEVIATION 1.4 • n=483 Participants
|
|
Physical Activity (Moderate-Vigorous)
|
17.7 Average Minute/Day
n=93 Participants
|
16.5 Average Minute/Day
n=4 Participants
|
15.0 Average Minute/Day
n=27 Participants
|
16.4 Average Minute/Day
n=483 Participants
|
PRIMARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENSNumeric rating scale of 0-10 (low to high scale) for pain with movement during six minute walk test; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test
Change at 4 weeks
|
-1.8 Units on a scale
Interval -2.3 to -1.2
|
-0.8 Units on a scale
Interval -1.4 to -0.2
|
0.00 Units on a scale
Interval -0.5 to 0.6
|
|
Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test
Change at 8 weeks
|
-2.0 Units on a scale
Interval -2.8 to -1.3
|
-1.9 Units on a scale
Interval -2.7 to -1.2
|
-1.9 Units on a scale
Interval -2.6 to -1.2
|
PRIMARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Numeric rating scale of 0-10 for pain with movement with five time sit to stand test. Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test
Change at 4 weeks
|
-1.6 units on a scale
Interval -2.3 to -1.0
|
-0.3 units on a scale
Interval -1.0 to 0.3
|
0.2 units on a scale
Interval -0.4 to 0.9
|
|
Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test
Change at 8 weeks
|
-1.9 units on a scale
Interval -2.6 to -1.1
|
-1.4 units on a scale
Interval -2.2 to -0.7
|
-1.3 units on a scale
Interval -2.1 to -0.6
|
SECONDARY outcome
Timeframe: Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS)Numeric rating scale of 0-10 for resting pain; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Resting Pain (0-10 Low to High Scale)
Change at 4 weeks
|
-1.9 units on a scale
Interval -2.5 to -1.4
|
-0.7 units on a scale
Interval -1.3 to -0.1
|
-0.5 units on a scale
Interval -1.1 to 0.0
|
|
Resting Pain (0-10 Low to High Scale)
Change at 8 weeks
|
-2.2 units on a scale
Interval -2.9 to -1.6
|
-1.9 units on a scale
Interval -2.6 to -1.2
|
-2.2 units on a scale
Interval -2.8 to -1.5
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Fatigue measured with 0-10 numeric rating scale during six minute walk test; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test
Change at 4 weeks
|
-1.5 Units on a scale
Interval -2.2 to -0.8
|
-0.1 Units on a scale
Interval -0.9 to 0.7
|
0.4 Units on a scale
Interval -0.3 to 1.1
|
|
Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test
Change at 8 weeks
|
-1.3 Units on a scale
Interval -2.0 to -0.6
|
-0.9 Units on a scale
Interval -1.7 to -0.2
|
-0.9 Units on a scale
Interval -1.7 to -0.2
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Fatigue measured by 0-10 numeric rating scale after five time sit to stand; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand
Change at 4 weeks
|
-1.2 Units on a scale
Interval -1.9 to -0.5
|
-0.0 Units on a scale
Interval -0.8 to 0.7
|
0.8 Units on a scale
Interval 0.1 to 1.5
|
|
Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand
Change at 8 weeks
|
-1.1 Units on a scale
Interval -1.9 to -0.4
|
-0.8 Units on a scale
Interval -1.6 to -0.1
|
-0.6 Units on a scale
Interval -1.4 to 0.1
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Population: Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS)
Fatigue measured at rest with a 0-10 numeric rating scale; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Resting Fatigue Rating (0-10 Low to High Scale)
Change at 4 weeks
|
-1.9 Units on a scale
Interval -2.6 to -1.2
|
-0.8 Units on a scale
Interval -1.5 to -0.04
|
-0.4 Units on a scale
Interval -1.0 to 0.4
|
|
Resting Fatigue Rating (0-10 Low to High Scale)
Change at 8 weeks
|
-2.1 Units on a scale
Interval -2.9 to -1.4
|
-1.6 Units on a scale
Interval -2.4 to -0.8
|
-1.8 Units on a scale
Interval -2.6 to -1.1
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Disease Impact self report Questionnaire, Scoring 0-100; higher score indicates greater disease impact; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Fibromyalgia Impact Questionnaire Revised
Change at 4 weeks
|
-8.5 Units on a scale
Interval -12.9 to 4.0
|
-3.4 Units on a scale
Interval -6.5 to 0.3
|
-1.39 Units on a scale
Interval -4.4 to 1.6
|
|
Fibromyalgia Impact Questionnaire Revised
Change at 8 weeks
|
-9.6 Units on a scale
Interval -13.8 to 5.4
|
-11.1 Units on a scale
Interval -15.2 to 7.0
|
-10.7 Units on a scale
Interval -14.8 to -6.6
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)numeric rating scale 0 to 10 from the Fibromyalgia Impact Questionnaire Revised: Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale)
Change at 8 weeks
|
-1.4 units on a scale
Interval -2.0 to -0.8
|
-1.2 units on a scale
Interval -1.7 to -0.6
|
-1.4 units on a scale
Interval -1.9 to -0.8
|
|
Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale)
Change at 4 weeks
|
-1.3 units on a scale
Interval -1.8 to -0.7
|
-0.4 units on a scale
Interval -0.9 to -0.2
|
-0.1 units on a scale
Interval -0.6 to 0.4
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Brief Pain Inventory - Interference; Score 0-10 with higher score indicating greater interference; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Brief Pain Inventory - Interference (0-10 Low to High Scale)
Change at 4 weeks
|
-0.9 units on a scale
Interval -1.4 to -0.5
|
-0.3 units on a scale
Interval -0.7 to 0.2
|
-0.3 units on a scale
Interval -0.7 to 0.2
|
|
Brief Pain Inventory - Interference (0-10 Low to High Scale)
Change at 8 weeks
|
-1.1 units on a scale
Interval -1.6 to -0.6
|
-0.9 units on a scale
Interval -1.4 to -0.3
|
-1.2 units on a scale
Interval -1.7 to -0.7
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Brief Pain Inventory - Interference, Scale of 0-10 with higher score indicating greater intensity; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Brief Pain Inventory, Intensity (0-10 Low to High Scale)
Change at 8 weeks
|
-1.0 units on a scale
Interval -1.4 to -0.6
|
-0.9 units on a scale
Interval -1.3 to -0.5
|
-0.9 units on a scale
Interval -1.2 to -0.5
|
|
Brief Pain Inventory, Intensity (0-10 Low to High Scale)
Change at 4 weeks
|
-0.8 units on a scale
Interval -1.1 to -0.4
|
-0.3 units on a scale
Interval -0.6 to 0.1
|
0.15 units on a scale
Interval -0.2 to 0.5
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Self report questionnaire with higher scores indicating greater kinesiophobia, score 17-68; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Tampa Scale of Kinesiophobia (17 to 68 Low to High)
Change at 4 weeks
|
-0.7 units on a scale
Interval -2.0 to 0.6
|
-0.3 units on a scale
Interval -1.7 to 1.0
|
-0.2 units on a scale
Interval -1.4 to 1.1
|
|
Tampa Scale of Kinesiophobia (17 to 68 Low to High)
Change at 8 weeks
|
-0.3 units on a scale
Interval -1.6 to 1.1
|
-2.3 units on a scale
Interval -3.7 to -0.9
|
-3.3 units on a scale
Interval -4.6 to -2.0
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Multidimensional Self Report Questionnaire, T-score; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups The SF36 Mental Health Component Score (MCS) quality of life measure. A T-Score of 50 represents the mean, with a standard deviation of 10, values less than 50 indicate a less than average score while values greater than 50 indicate greater than average scores" . Higher T-scores reflect better quality of life and lower T-score reflect lesser quality of life
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Short Form Survey 36; Mental Component Score (T Score Mean of 50)
Change at 4 weeks
|
2.3 T-Score
Interval 0.2 to 4.4
|
1.2 T-Score
Interval -0.9 to 3.4
|
-0.04 T-Score
Interval -2.1 to 2.0
|
|
Short Form Survey 36; Mental Component Score (T Score Mean of 50)
Change at 8 weeks
|
2.1 T-Score
Interval -0.2 to 4.4
|
3.6 T-Score
Interval 1.3 to 6.0
|
2.8 T-Score
Interval 0.6 to 5.0
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Multidimensional self report scale, T score change; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups The SF36 Physical Functioning Component Score (PCS) quality of life measure. A T-Score of 50 represents the mean, with a standard deviation of 10, values less than 50 indicate a less than average score while values greater than 50 indicate greater than average scores" . Higher T-scores reflect better quality of life and lower T-score reflect lesser quality of life .
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health
Change at 4 weeks
|
2.4 T-Score
Interval 1.0 to 3.7
|
1.2 T-Score
Interval -0.2 to 2.5
|
1.4 T-Score
Interval 0.1 to 2.6
|
|
Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health
Change at 8 weeks
|
3.5 T-Score
Interval 2.0 to 5.1
|
3.2 T-Score
Interval 1.6 to 4.8
|
4.4 T-Score
Interval 2.9 to 5.9
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)6MWT - Feet walked as fast as comfortable in six minute; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Six Minute Walk Test
Change at 4 weeks
|
-1 Feet
Interval -55.0 to 54.0
|
-20 Feet
Interval -75.0 to 36.0
|
-42.1 Feet
Interval -95.0 to 11.0
|
|
Six Minute Walk Test
Change at 8 weeks
|
15 Feet
Interval -42.0 to 71.0
|
16 Feet
Interval -41.0 to 74.0
|
-2 Feet
Interval -57.0 to 53.0
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Time for sit to stand for 5 repetitions converted to a rate of number of sit to stand per 10 seconds; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Five Time Sit to Stand Test Rate Per 10 Seconds
Change at 4 weeks
|
0.6 sit-to-stand repetitions/10 seconds
Interval 0.3 to 1.0
|
0.4 sit-to-stand repetitions/10 seconds
Interval 0.0 to 0.7
|
0.1 sit-to-stand repetitions/10 seconds
Interval -0.3 to 0.4
|
|
Five Time Sit to Stand Test Rate Per 10 Seconds
Change at 8 weeks
|
0.6 sit-to-stand repetitions/10 seconds
Interval 0.2 to 1.0
|
0.8 sit-to-stand repetitions/10 seconds
Interval 0.4 to 1.3
|
0.6 sit-to-stand repetitions/10 seconds
Interval 0.1 to 1.0
|
SECONDARY outcome
Timeframe: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)Accelerometry data classification of physical activity in minutes per day, percent change; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups
Outcome measures
| Measure |
Active TENS
n=103 Participants
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 Participants
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 Participants
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
|---|---|---|---|
|
Moderate Vigorous Physical Activity Minutes Per Day
Change at 4 weeks
|
-9.4 Minutes per day
Interval -27.8 to 13.5
|
2.5 Minutes per day
Interval -18.6 to 29.1
|
-14.1 Minutes per day
Interval -29.5 to 4.7
|
|
Moderate Vigorous Physical Activity Minutes Per Day
Change at 8 weeks
|
-6.8 Minutes per day
Interval -27.2 to 19.3
|
-0.3 Minutes per day
Interval -22.3 to 27.9
|
-17.0 Minutes per day
Interval -33.9 to 4.1
|
Adverse Events
Active TENS
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo TENS
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
No TENS (Standard Care)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Pre-Randomization
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active TENS
n=103 participants at risk
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 participants at risk
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 participants at risk
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
Pre-Randomization
n=352 participants at risk
Participants who attended visit 1 or 2 prior to randomization to intervention
|
|---|---|---|---|---|
|
Cardiac disorders
Chest pain
|
0.00%
0/103 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/99 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/99 • Visit 1 to Visit 4, 9 weeks
|
0.28%
1/352 • Number of events 1 • Visit 1 to Visit 4, 9 weeks
|
|
Gastrointestinal disorders
Dehydration and gastrointestinal pain
|
0.00%
0/103 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/99 • Visit 1 to Visit 4, 9 weeks
|
1.0%
1/99 • Number of events 1 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/103 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/99 • Visit 1 to Visit 4, 9 weeks
|
1.0%
1/99 • Number of events 1 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
Other adverse events
| Measure |
Active TENS
n=103 participants at risk
Active TENS for 4 weeks of the study and will add an additional 4 weeks of active TENS for the last 4 weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
Placebo TENS
n=99 participants at risk
This group will receive placebo TENS for the first 4 weeks of the study and then active TENS for the last four weeks of the study.
TENS: TENS Parameters: Active TENS and Placebo TENS
* TENS Frequency - 10 to100 Hz
* TENS Pulse Width - 200 µs
* TENS Intensity - Maximal tolerable intensity
* Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
* Administration - Daily
* TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
Placebo TENS Unit Active TENS unit Stand Care - no TENS
|
No TENS (Standard Care)
n=99 participants at risk
Subjects will not receive TENS intervention during the first 4 weeks of the trial but will complete all testing procedures as the other two arms. This group will receive active TENS during the last 4 weeks of the study.
|
Pre-Randomization
n=352 participants at risk
Participants who attended visit 1 or 2 prior to randomization to intervention
|
|---|---|---|---|---|
|
Nervous system disorders
Pain with testing
|
11.7%
12/103 • Number of events 12 • Visit 1 to Visit 4, 9 weeks
|
10.1%
10/99 • Number of events 10 • Visit 1 to Visit 4, 9 weeks
|
15.2%
15/99 • Number of events 15 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory
|
6.8%
7/103 • Number of events 7 • Visit 1 to Visit 4, 9 weeks
|
7.1%
7/99 • Number of events 7 • Visit 1 to Visit 4, 9 weeks
|
3.0%
3/99 • Number of events 3 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
General disorders
Pain with TENS; At home, unspecified
|
3.9%
4/103 • Number of events 4 • Visit 1 to Visit 4, 9 weeks
|
4.0%
4/99 • Number of events 4 • Visit 1 to Visit 4, 9 weeks
|
3.0%
3/99 • Number of events 3 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Irritation from actigraph band
|
1.9%
2/103 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
3.0%
3/99 • Number of events 3 • Visit 1 to Visit 4, 9 weeks
|
1.0%
1/99 • Number of events 1 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Irritation with Electrodes
|
5.8%
6/103 • Number of events 6 • Visit 1 to Visit 4, 9 weeks
|
2.0%
2/99 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/99 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
Infections and infestations
Bladder Infection
|
1.9%
2/103 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
2.0%
2/99 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
2.0%
2/99 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Common Cold
|
2.9%
3/103 • Number of events 3 • Visit 1 to Visit 4, 9 weeks
|
4.0%
4/99 • Number of events 4 • Visit 1 to Visit 4, 9 weeks
|
2.0%
2/99 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
Infections and infestations
Sinus Infection
|
1.9%
2/103 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
2.0%
2/99 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
2.0%
2/99 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
6.8%
7/103 • Number of events 7 • Visit 1 to Visit 4, 9 weeks
|
7.1%
7/99 • Number of events 7 • Visit 1 to Visit 4, 9 weeks
|
3.0%
3/99 • Number of events 3 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
General disorders
Fall
|
3.9%
4/103 • Number of events 4 • Visit 1 to Visit 4, 9 weeks
|
3.0%
3/99 • Number of events 3 • Visit 1 to Visit 4, 9 weeks
|
2.0%
2/99 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
General disorders
Headache or Migraine
|
2.9%
3/103 • Number of events 3 • Visit 1 to Visit 4, 9 weeks
|
3.0%
3/99 • Number of events 3 • Visit 1 to Visit 4, 9 weeks
|
1.0%
1/99 • Number of events 1 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
|
General disorders
Dental Procedures
|
1.9%
2/103 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
2.0%
2/99 • Number of events 2 • Visit 1 to Visit 4, 9 weeks
|
3.0%
3/99 • Number of events 3 • Visit 1 to Visit 4, 9 weeks
|
0.00%
0/352 • Visit 1 to Visit 4, 9 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place