Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM) (NCT NCT00932360)
NCT ID: NCT00932360
Last Updated: 2019-01-16
Results Overview
Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
3 weeks
Results posted on
2019-01-16
Participant Flow
Subjects (125) were screened for eligibility via telephone. 82 were excluded and 43 were consented and enrolled at the University of Iowa
43 subjects were consented and enrolled to the cross over design study. Subjects were randomized to treatment group order after providing written consent. The three treatment groups for randomization order included: active TENS, placebo TENS and no treatment TENS.
Participant milestones
| Measure |
Active TENS, Placebo TENS and No TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
Active TENS No TENS Placebo TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
Placebo TENS Active TENS No TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
Placebo TENS No TENS Active TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
No TENS Active TENS Placebo TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
No TENS Placebo TENS Active TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
|---|---|---|---|---|---|---|
|
1: Visit 1/Week1
STARTED
|
10
|
6
|
3
|
13
|
4
|
7
|
|
1: Visit 1/Week1
COMPLETED
|
10
|
6
|
3
|
13
|
4
|
7
|
|
1: Visit 1/Week1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout (One Week)
STARTED
|
10
|
6
|
3
|
13
|
2
|
7
|
|
Washout (One Week)
COMPLETED
|
10
|
6
|
3
|
13
|
2
|
7
|
|
Washout (One Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Visit 2/Week 2
STARTED
|
10
|
6
|
3
|
13
|
2
|
7
|
|
Visit 2/Week 2
COMPLETED
|
10
|
6
|
3
|
13
|
2
|
7
|
|
Visit 2/Week 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Visit 3/Week 3
STARTED
|
10
|
6
|
3
|
13
|
2
|
7
|
|
Visit 3/Week 3
COMPLETED
|
10
|
6
|
3
|
13
|
2
|
7
|
|
Visit 3/Week 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Active TENS, Placebo TENS and No TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
Active TENS No TENS Placebo TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
Placebo TENS Active TENS No TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
Placebo TENS No TENS Active TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
No TENS Active TENS Placebo TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
No TENS Placebo TENS Active TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
|
|---|---|---|---|---|---|---|
|
Washout (One Week)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
2 subjects withdrew from the study after the first visit
Baseline characteristics by cohort
| Measure |
All Study Participants
n=43 Participants
This is a crossover study with three groups. Subjects completed each arm of the study in random order.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants • 2 subjects withdrew from the study after the first visit
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants • 2 subjects withdrew from the study after the first visit
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants • 2 subjects withdrew from the study after the first visit
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants • 2 subjects withdrew from the study after the first visit
|
|
Race (NIH/OMB)
White
|
43 Participants
n=93 Participants • 2 subjects withdrew from the study after the first visit
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants • 2 subjects withdrew from the study after the first visit
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants • 2 subjects withdrew from the study after the first visit
|
|
Region of Enrollment
United States
|
43 participants
n=93 Participants • 2 subjects withdrew after 1 visit
|
PRIMARY outcome
Timeframe: 3 weeksVisual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.
Outcome measures
| Measure |
Active TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
Placebo TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
No TENS
n=41 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
|---|---|---|---|
|
Pain at Rest Difference Score Pre-intervention and Post Intervention
|
0.38 units on a scale
Standard Error 0.26
|
-0.74 units on a scale
Standard Error 0.25
|
-0.47 units on a scale
Standard Error 0.26
|
PRIMARY outcome
Timeframe: 3 weeksVisual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.
Outcome measures
| Measure |
Active TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
Placebo TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
No TENS
n=41 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
|---|---|---|---|
|
Pain With Movement Difference Score Pre-intervention and Post Intervention
|
1.11 score on a scale
Standard Error 0.26
|
0.23 score on a scale
Standard Error 0.26
|
0.26 score on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 3 weeksVisual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.
Outcome measures
| Measure |
Active TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
Placebo TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
No TENS
n=41 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
|---|---|---|---|
|
Fatigue at Rest Difference Score Pre-intervention and Post Intervention
|
-0.09 units on a scale
Standard Error 0.21
|
-0.14 units on a scale
Standard Error 0.21
|
0.12 units on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: 3 weeksVisual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.
Outcome measures
| Measure |
Active TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
Placebo TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
No TENS
n=41 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
|---|---|---|---|
|
Fatigue With Movement Difference Score Pre-intervention and Post Intervention
|
0.94 units on a scale
Standard Error 0.23
|
0.39 units on a scale
Standard Error 0.24
|
0.04 units on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: 3 weeksPressure pain threshold cervical region (kPa)
Outcome measures
| Measure |
Active TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
Placebo TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
No TENS
n=41 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
|---|---|---|---|
|
PPT Cervical Region
|
53.15 pressure score (kPa)
Standard Error 10.09
|
26.42 pressure score (kPa)
Standard Error 10.02
|
19.39 pressure score (kPa)
Standard Error 10.06
|
SECONDARY outcome
Timeframe: 3 weeksPressure pain threshold in lumbar region (kPa)
Outcome measures
| Measure |
Active TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
Placebo TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
No TENS
n=41 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
|---|---|---|---|
|
PPT Lumbar Region
|
86.97 pressure score (kPa)
Standard Error 15.97
|
34.89 pressure score (kPa)
Standard Error 15.91
|
33.23 pressure score (kPa)
Standard Error 15.95
|
SECONDARY outcome
Timeframe: 3 weeksPressure pain threshold in leg (kPa)
Outcome measures
| Measure |
Active TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
Placebo TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
No TENS
n=41 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
|---|---|---|---|
|
PPT for Anterior Tibialis
|
62.86 pressure score (kPa)
Standard Error 18.34
|
38.98 pressure score (kPa)
Standard Error 21.85
|
4.4 pressure score (kPa)
Standard Error 15.47
|
SECONDARY outcome
Timeframe: 3 weeks6 minute walk test average change (feet) before and after intervention
Outcome measures
| Measure |
Active TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
Placebo TENS
n=43 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
No TENS
n=41 Participants
Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.
|
|---|---|---|---|
|
6 Minute Walk Test Average Change (Feet)
|
41.85 feet
Standard Error 36.7
|
-40.48 feet
Standard Error 36.31
|
-0.97 feet
Standard Error 36.01
|
Adverse Events
Active TENS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo TENS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No TENS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place