Fibromyalgia
Conditions
Keywords
TENS, Fibromyalgia, Accelerometer
Brief summary
Pain associated with fibromyalgia interferes with daily function, work, and social activities resulting in a decreased quality of life. People with fibromyalgia also have a significant amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability of pain neurons in the central nervous system and reduced pain inhibition. Therefore, one of the main treatments for patients with fibromyalgia must focus on pain relief to allow the person to function more independently both at home and at work. Transcutaneous electrical nerve stimulation is used by health professionals to deliver electrical stimulation through the skin for pain control. Basic science studies, from the PI's laboratory show that TENS activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus the ideal patient population for the treatment of TENS would be one in which there is enhanced central excitability and reduced inhibition; fibromyalgia is such a condition. Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and that this decrease in pain and/or central excitability will reduce fatigue and fear of movement, thereby improving function and quality of life
Detailed description
This is a phase II randomized, double-blind, placebo controlled multi-center clinical trial involving a device, Transcutaneous Electrical Nerve Stimulation (TENS). TENS is a non-pharmacological agent which delivers electrical stimulation by a battery operated device via electrodes placed on the skin. TENS is considered to be a safe, inexpensive and non-invasive modality used to treat a variety of acute and chronic pain conditions. The initial phase of the study will randomly allocate subjects to receive active TENS, placebo TENS or standard care (No TENS). After participating in the 1 month random assignment, all subjects will receive active TENS for 1 month. The subjects will make 4 visits to the clinic approximately 2 to 3 1/2 hours each visit. Visits will entail questionnaires, functional tasks, accelerometry, TENS, pain and fatigue assessments. Study Aims: Aim #1: The primary aim of the study is to test the effectiveness of repeated TENS use on movement-related pain in people with fibromyalgia with random assignment to three treatments: standard care, placebo TENS and active Aim #2: A secondary aim will test if pain reduction by TENs results in a concomitant decrease in fatigue and fear of movement, and an increase in function and quality of life. Outcome measures will include physical function by directly assessing daily activity with an accelerometer, as well as performing specific functional tasks
Interventions
DEVICETENS
TENS Parameters: Active TENS and Placebo TENS * TENS Frequency - 2-125 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 No TENS - Standard Care
Sponsors
Vanderbilt University
Kathleen Sluka
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants will be 18 to 70 years of age * Women may participate in the study, with the understanding that within the clinical population of fibromyalgia the there is a 7:1 ratio of female to male. * Diagnosis of Fibromyalgia by 1990 ACR criteria (11/18 tender points) * History of cervical or lumbar pain with fibromyalgia (this is expected in all patients since axial pain is required for diagnosis) * Current stable treatment regimen for the last 4 weeks and projected stable treatment regimen for the next 2 months. * English speaking
Exclusion criteria
* Current or history of cardiovascular, pulmonary, neurological, endocrine, or renal disease that would preclude the involvement in the study. * TENS use in the last 5 years * Pacemaker * Uncontrolled blood pressure or diabetes * Neuropathic pain condition * Systemic autoimmune disorder (Lupus, PMR, RA, Psoriasis, Psoriatic arthritis) * Spinal fusion - cervical or lumbar * Metal implants in cervical or lumbar region * Severe skin allergy to adhesive * Allergy to nickel * Pain level less than 4 * Pregnancy * Epilepsy * Change in or new drug or treatment program within the last month or in the next 2months, i.e. must have a stable treatment plan * Unstable medical or psychiatric condition which in the opinion of the investigator could compromise the subject's welfare or confound the study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test | 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 (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 |
| Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand | 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 |
| Resting Fatigue Rating (0-10 Low to High Scale) | Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, 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 |
| Fibromyalgia Impact Questionnaire Revised | 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 |
| Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) | 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 |
| Brief Pain Inventory - Interference (0-10 Low to High Scale) | 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 |
| Brief Pain Inventory, Intensity (0-10 Low to High Scale) | 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 |
| Resting Pain (0-10 Low to High Scale) | 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 |
| Short Form Survey 36; Mental Component Score (T Score Mean of 50) | 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 |
| Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health | 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 . |
| Six Minute Walk Test | 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 |
| Five Time Sit to Stand Test Rate Per 10 Seconds | 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 |
| Moderate Vigorous Physical Activity Minutes Per Day | 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 |
| Tampa Scale of Kinesiophobia (17 to 68 Low to High) | 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 |
| Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 103 |
| 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 | 99 |
| 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. | 99 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Excluded for prior TENS | 0 | 1 | 0 |
| Overall Study | Given wrong unit (placebo) | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 |
| Overall Study | Minimum dose not met | 10 | 16 | 0 |
| Overall Study | Researcher Termination of Participant | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 15 | 11 | 4 |
Baseline characteristics
| Characteristic | Active TENS | Placebo TENS | no TENS (Standard Care) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 4 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants | 93 Participants | 95 Participants | 285 Participants |
| Age, Continuous | 44.7 Years STANDARD_DEVIATION 14.3 | 47.2 Years STANDARD_DEVIATION 12.6 | 48.6 Years STANDARD_DEVIATION 11.8 | 46.8 Years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants | 92 Participants | 88 Participants | 276 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 6 Participants | 10 Participants |
| Fatigue at rest | 6.8 0 to 10 low to high scale STANDARD_DEVIATION 2 | 6.1 0 to 10 low to high scale STANDARD_DEVIATION 1.8 | 6.4 0 to 10 low to high scale STANDARD_DEVIATION 2 | 6.43 0 to 10 low to high scale STANDARD_DEVIATION 1.9 |
| Fibromyalgia Impact Questionnaire Revised | 59.2 Scoring 0 to 100 low to high scale STANDARD_DEVIATION 16.8 | 53.7 Scoring 0 to 100 low to high scale STANDARD_DEVIATION 15.9 | 55.6 Scoring 0 to 100 low to high scale STANDARD_DEVIATION 16 | 56.1 Scoring 0 to 100 low to high scale STANDARD_DEVIATION 16.2 |
| Fibromyalgia Impact Questionnaire Revised - Pain | 6.7 0 to 10 low to high scale STANDARD_DEVIATION 1.8 | 6.0 0 to 10 low to high scale STANDARD_DEVIATION 1.6 | 6.15 0 to 10 low to high scale STANDARD_DEVIATION 1.8 | 6.28 0 to 10 low to high scale STANDARD_DEVIATION 1.7 |
| Five time sit to stand | 4.1 sit-to-stand repetitions/10 seconds STANDARD_DEVIATION 1.5 | 4.0 sit-to-stand repetitions/10 seconds STANDARD_DEVIATION 1.4 | 3.9 sit-to-stand repetitions/10 seconds STANDARD_DEVIATION 1.5 | 4.0 sit-to-stand repetitions/10 seconds STANDARD_DEVIATION 1.4 |
| Pain at rest | 6.2 0 to 10 low to high scale STANDARD_DEVIATION 1.5 | 5.9 0 to 10 low to high scale STANDARD_DEVIATION 1.4 | 6.1 0 to 10 low to high scale STANDARD_DEVIATION 1.6 | 6.0 0 to 10 low to high scale STANDARD_DEVIATION 1.5 |
| Pain with movement five time sit to stand | 5.8 0 to 10 low to high scale STANDARD_DEVIATION 2.4 | 5.5 0 to 10 low to high scale STANDARD_DEVIATION 2.2 | 5.6 0 to 10 low to high scale STANDARD_DEVIATION 2.2 | 5.6 0 to 10 low to high scale STANDARD_DEVIATION 2.2 |
| Pain with movement six minute walk test | 6.5 0 to 10 low to high scale STANDARD_DEVIATION 1.9 | 6.2 0 to 10 low to high scale STANDARD_DEVIATION 1.9 | 6.4 0 to 10 low to high scale STANDARD_DEVIATION 1.9 | 6.4 0 to 10 low to high scale STANDARD_DEVIATION 1.9 |
| Physical Activity (Moderate-Vigorous) | 17.7 Average Minute/Day | 16.5 Average Minute/Day | 15.0 Average Minute/Day | 16.4 Average Minute/Day |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) White | 90 Participants | 87 Participants | 85 Participants | 262 Participants |
| Region of Enrollment United States | 103 participants | 99 participants | 99 participants | 301 participants |
| Sex: Female, Male Female | 103 Participants | 99 Participants | 99 Participants | 301 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Short Form 36 Mental Health Component Score | 38.7 T-score mean of 50 STANDARD_DEVIATION 10 | 40.2 T-score mean of 50 STANDARD_DEVIATION 10.2 | 39.5 T-score mean of 50 STANDARD_DEVIATION 10.6 | 39.4 T-score mean of 50 STANDARD_DEVIATION 10.2 |
| Short Form 36 Physical Component Score | 32.7 T-score mean of 50 STANDARD_DEVIATION 6.4 | 33.3 T-score mean of 50 STANDARD_DEVIATION 6.2 | 32.7 T-score mean of 50 STANDARD_DEVIATION 6.6 | 32.9 T-score mean of 50 STANDARD_DEVIATION 6.4 |
| Six minute walk test (Feet) | 1386 Feet STANDARD_DEVIATION 323 | 1358 Feet STANDARD_DEVIATION 305 | 1316 Feet STANDARD_DEVIATION 318 | 1353.3 Feet STANDARD_DEVIATION 315 |
| Tampa Scale of Kinesiophobia | 36.5 Scoring 17 to 68 low to high STANDARD_DEVIATION 7.7 | 37.1 Scoring 17 to 68 low to high STANDARD_DEVIATION 8 | 37.4 Scoring 17 to 68 low to high STANDARD_DEVIATION 8.3 | 37 Scoring 17 to 68 low to high STANDARD_DEVIATION 8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 99 | 0 / 99 | 0 / 352 |
| other Total, other adverse events | 12 / 103 | 10 / 99 | 15 / 99 | 0 / 352 |
| serious Total, serious adverse events | 0 / 103 | 1 / 99 | 2 / 99 | 1 / 352 |
Outcome results
Primary
Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | 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 |
| Active TENS | 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 |
| Placebo TENS | Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test | Change at 4 weeks | -0.3 units on a scale |
| Placebo TENS | Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test | Change at 8 weeks | -1.4 units on a scale |
| No TENS (Standard Care) | Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test | Change at 4 weeks | 0.2 units on a scale |
| No TENS (Standard Care) | Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test | Change at 8 weeks | -1.3 units on a scale |
Comparison: Visit 2 to Visit 3p-value: 0.00295% CI: [-2.2, -0.4]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: <0.000195% CI: [-2.8, -1]Linear mixed models for repeated measure
Primary
Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | 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 |
| Active TENS | 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 |
| Placebo TENS | Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test | Change at 8 weeks | -1.9 Units on a scale |
| Placebo TENS | Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test | Change at 4 weeks | -0.8 Units on a scale |
| No TENS (Standard Care) | Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test | Change at 4 weeks | 0.00 Units on a scale |
| No TENS (Standard Care) | Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test | Change at 8 weeks | -1.9 Units on a scale |
Comparison: Visit 2-Visit 3p-value: 0.00895% CI: [-1.8, -0.2]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: <0.000195% CI: [-2.6, -1]Linear mixed models for repeated measure
Secondary
Brief Pain Inventory, Intensity (0-10 Low to High Scale)
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Brief Pain Inventory, Intensity (0-10 Low to High Scale) | Change at 4 weeks | -0.8 units on a scale |
| Active TENS | Brief Pain Inventory, Intensity (0-10 Low to High Scale) | Change at 8 weeks | -1.0 units on a scale |
| Placebo TENS | Brief Pain Inventory, Intensity (0-10 Low to High Scale) | Change at 4 weeks | -0.3 units on a scale |
| Placebo TENS | Brief Pain Inventory, Intensity (0-10 Low to High Scale) | Change at 8 weeks | -0.9 units on a scale |
| No TENS (Standard Care) | Brief Pain Inventory, Intensity (0-10 Low to High Scale) | Change at 4 weeks | 0.15 units on a scale |
| No TENS (Standard Care) | Brief Pain Inventory, Intensity (0-10 Low to High Scale) | Change at 8 weeks | -0.9 units on a scale |
Comparison: Visit 2 to Visit 3p-value: 0.03695% CI: [-1, 0]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: <0.000195% CI: [-1.4, -0.4]Linear mixed models for repeated measure
Secondary
Brief Pain Inventory - Interference (0-10 Low to High Scale)
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Brief Pain Inventory - Interference (0-10 Low to High Scale) | Change at 4 weeks | -0.9 units on a scale |
| Active TENS | Brief Pain Inventory - Interference (0-10 Low to High Scale) | Change at 8 weeks | -1.1 units on a scale |
| Placebo TENS | Brief Pain Inventory - Interference (0-10 Low to High Scale) | Change at 4 weeks | -0.3 units on a scale |
| Placebo TENS | Brief Pain Inventory - Interference (0-10 Low to High Scale) | Change at 8 weeks | -0.9 units on a scale |
| No TENS (Standard Care) | Brief Pain Inventory - Interference (0-10 Low to High Scale) | Change at 4 weeks | -0.3 units on a scale |
| No TENS (Standard Care) | Brief Pain Inventory - Interference (0-10 Low to High Scale) | Change at 8 weeks | -1.2 units on a scale |
Comparison: Visit 2 to Visit 3p-value: 0.04395% CI: [-1.3, -0.01]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: 0.04895% CI: [-1.3, 0]Linear mixed models for repeated measure
Secondary
Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand | Change at 4 weeks | -1.2 Units on a scale |
| Active TENS | Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand | Change at 8 weeks | -1.1 Units on a scale |
| Placebo TENS | Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand | Change at 4 weeks | -0.0 Units on a scale |
| Placebo TENS | Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand | Change at 8 weeks | -0.8 Units on a scale |
| No TENS (Standard Care) | Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand | Change at 4 weeks | 0.8 Units on a scale |
| No TENS (Standard Care) | Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand | Change at 8 weeks | -0.6 Units on a scale |
Comparison: Visit 2 to Visit 3p-value: 0.01195% CI: [-2.2, -0.2]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: <0.000195% CI: [-3, -1]Linear mixed models for repeated measure
Secondary
Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test | Change at 4 weeks | -1.5 Units on a scale |
| Active TENS | Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test | Change at 8 weeks | -1.3 Units on a scale |
| Placebo TENS | Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test | Change at 4 weeks | -0.1 Units on a scale |
| Placebo TENS | Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test | Change at 8 weeks | -0.9 Units on a scale |
| No TENS (Standard Care) | Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test | Change at 4 weeks | 0.4 Units on a scale |
| No TENS (Standard Care) | Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test | Change at 8 weeks | -0.9 Units on a scale |
Comparison: Visit 2 to Visit 3p-value: 0.00195% CI: [-2.4, -0.4]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: <0.000195% CI: [-2.9, -0.9]Linear mixed models for repeated measure
Secondary
Fibromyalgia Impact Questionnaire Revised
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Fibromyalgia Impact Questionnaire Revised | Change at 4 weeks | -8.5 Units on a scale |
| Active TENS | Fibromyalgia Impact Questionnaire Revised | Change at 8 weeks | -9.6 Units on a scale |
| Placebo TENS | Fibromyalgia Impact Questionnaire Revised | Change at 4 weeks | -3.4 Units on a scale |
| Placebo TENS | Fibromyalgia Impact Questionnaire Revised | Change at 8 weeks | -11.1 Units on a scale |
| No TENS (Standard Care) | Fibromyalgia Impact Questionnaire Revised | Change at 8 weeks | -10.7 Units on a scale |
| No TENS (Standard Care) | Fibromyalgia Impact Questionnaire Revised | Change at 4 weeks | -1.39 Units on a scale |
Comparison: Visit 2 to Visit 3p-value: 0.07495% CI: [-10.4, 0.3]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: 0.00595% CI: [-12.4, -1.8]Linear mixed models for repeated measure
Secondary
Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale)
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) | Change at 4 weeks | -1.3 units on a scale |
| Active TENS | Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) | Change at 8 weeks | -1.4 units on a scale |
| Placebo TENS | Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) | Change at 4 weeks | -0.4 units on a scale |
| Placebo TENS | Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) | Change at 8 weeks | -1.2 units on a scale |
| No TENS (Standard Care) | Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) | Change at 4 weeks | -0.1 units on a scale |
| No TENS (Standard Care) | Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) | Change at 8 weeks | -1.4 units on a scale |
Comparison: Visit 2 to Visit 3p-value: 0.01895% CI: [-1.7, -0.1]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: 0.000695% CI: [-1.9, -0.4]Linear mixed models for repeated measure
Secondary
Five Time Sit to Stand Test Rate Per 10 Seconds
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Five Time Sit to Stand Test Rate Per 10 Seconds | Change at 4 weeks | 0.6 sit-to-stand repetitions/10 seconds |
| Active TENS | Five Time Sit to Stand Test Rate Per 10 Seconds | Change at 8 weeks | 0.6 sit-to-stand repetitions/10 seconds |
| Placebo TENS | Five Time Sit to Stand Test Rate Per 10 Seconds | Change at 4 weeks | 0.4 sit-to-stand repetitions/10 seconds |
| Placebo TENS | Five Time Sit to Stand Test Rate Per 10 Seconds | Change at 8 weeks | 0.8 sit-to-stand repetitions/10 seconds |
| No TENS (Standard Care) | Five Time Sit to Stand Test Rate Per 10 Seconds | Change at 4 weeks | 0.1 sit-to-stand repetitions/10 seconds |
| No TENS (Standard Care) | Five Time Sit to Stand Test Rate Per 10 Seconds | Change at 8 weeks | 0.6 sit-to-stand repetitions/10 seconds |
Comparison: Visit 2 to Visit 3p-value: 0.9695% CI: [-0.2, 0.7]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: 0.00895% CI: [0.1, 1]Linear mixed models for repeated measure
Secondary
Moderate Vigorous Physical Activity Minutes Per Day
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Moderate Vigorous Physical Activity Minutes Per Day | Change at 8 weeks | -6.8 Minutes per day |
| Active TENS | Moderate Vigorous Physical Activity Minutes Per Day | Change at 4 weeks | -9.4 Minutes per day |
| Placebo TENS | Moderate Vigorous Physical Activity Minutes Per Day | Change at 4 weeks | 2.5 Minutes per day |
| Placebo TENS | Moderate Vigorous Physical Activity Minutes Per Day | Change at 8 weeks | -0.3 Minutes per day |
| No TENS (Standard Care) | Moderate Vigorous Physical Activity Minutes Per Day | Change at 4 weeks | -14.1 Minutes per day |
| No TENS (Standard Care) | Moderate Vigorous Physical Activity Minutes Per Day | Change at 8 weeks | -17.0 Minutes per day |
Comparison: Visit 2 to Visit 3p-value: >0.99Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: >0.99Linear mixed models for repeated measure
Secondary
Resting Fatigue Rating (0-10 Low to High Scale)
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
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Resting Fatigue Rating (0-10 Low to High Scale) | Change at 8 weeks | -2.1 Units on a scale |
| Active TENS | Resting Fatigue Rating (0-10 Low to High Scale) | Change at 4 weeks | -1.9 Units on a scale |
| Placebo TENS | Resting Fatigue Rating (0-10 Low to High Scale) | Change at 8 weeks | -1.6 Units on a scale |
| Placebo TENS | Resting Fatigue Rating (0-10 Low to High Scale) | Change at 4 weeks | -0.8 Units on a scale |
| No TENS (Standard Care) | Resting Fatigue Rating (0-10 Low to High Scale) | Change at 4 weeks | -0.4 Units on a scale |
| No TENS (Standard Care) | Resting Fatigue Rating (0-10 Low to High Scale) | Change at 8 weeks | -1.8 Units on a scale |
Comparison: Visit 2 to Visit 3p-value: 0.01695% CI: [-2.2, -0.1]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: 0.000295% CI: [-2.6, -0.6]Linear mixed models for repeated measure
Secondary
Resting Pain (0-10 Low to High Scale)
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
Time frame: Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Resting Pain (0-10 Low to High Scale) | Change at 4 weeks | -1.9 units on a scale |
| Active TENS | Resting Pain (0-10 Low to High Scale) | Change at 8 weeks | -2.2 units on a scale |
| Placebo TENS | Resting Pain (0-10 Low to High Scale) | Change at 4 weeks | -0.7 units on a scale |
| Placebo TENS | Resting Pain (0-10 Low to High Scale) | Change at 8 weeks | -1.9 units on a scale |
| No TENS (Standard Care) | Resting Pain (0-10 Low to High Scale) | Change at 4 weeks | -0.5 units on a scale |
| No TENS (Standard Care) | Resting Pain (0-10 Low to High Scale) | Change at 8 weeks | -2.2 units on a scale |
Comparison: Visit 2 to Visit 3p-value: 0.000695% CI: [-2.1, -0.4]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: <0.000195% CI: [-2.2, -0.6]Linear mixed models for repeated measure
Secondary
Short Form Survey 36; Mental Component Score (T Score Mean of 50)
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Short Form Survey 36; Mental Component Score (T Score Mean of 50) | Change at 4 weeks | 2.3 T-Score |
| Active TENS | Short Form Survey 36; Mental Component Score (T Score Mean of 50) | Change at 8 weeks | 2.1 T-Score |
| Placebo TENS | Short Form Survey 36; Mental Component Score (T Score Mean of 50) | Change at 4 weeks | 1.2 T-Score |
| Placebo TENS | Short Form Survey 36; Mental Component Score (T Score Mean of 50) | Change at 8 weeks | 3.6 T-Score |
| No TENS (Standard Care) | Short Form Survey 36; Mental Component Score (T Score Mean of 50) | Change at 4 weeks | -0.04 T-Score |
| No TENS (Standard Care) | Short Form Survey 36; Mental Component Score (T Score Mean of 50) | Change at 8 weeks | 2.8 T-Score |
Comparison: Visit 2 to Visit 3p-value: >0.9995% CI: [-1.9, 4.1]Linear mixed models for repeated measure
p-value: 0.1795% CI: [-0.6, 5.3]Linear mixed models for repeated measure
Secondary
Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health
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 .
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | 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 |
| Active TENS | 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 |
| Placebo TENS | Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health | Change at 4 weeks | 1.2 T-Score |
| Placebo TENS | Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health | Change at 8 weeks | 3.2 T-Score |
| No TENS (Standard Care) | Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health | Change at 4 weeks | 1.4 T-Score |
| No TENS (Standard Care) | Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health | Change at 8 weeks | 4.4 T-Score |
Comparison: Visit 2 to Visit 3p-value: 0.3695% CI: [-0.7, 3.1]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: 0.5895% CI: [-0.8, 2.8]Linear mixed models for repeated measure
Secondary
Six Minute Walk Test
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Six Minute Walk Test | Change at 4 weeks | -1 Feet |
| Active TENS | Six Minute Walk Test | Change at 8 weeks | 15 Feet |
| Placebo TENS | Six Minute Walk Test | Change at 4 weeks | -20 Feet |
| Placebo TENS | Six Minute Walk Test | Change at 8 weeks | 16 Feet |
| No TENS (Standard Care) | Six Minute Walk Test | Change at 4 weeks | -42.1 Feet |
| No TENS (Standard Care) | Six Minute Walk Test | Change at 8 weeks | -2 Feet |
Comparison: Visit 2 to Visit 3p-value: >0.9995% CI: [-58, 96]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: >0.9995% CI: [-34, 117]Linear mixed models for repeated measure
Secondary
Tampa Scale of Kinesiophobia (17 to 68 Low to High)
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
Time frame: Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active TENS | Tampa Scale of Kinesiophobia (17 to 68 Low to High) | Change at 4 weeks | -0.7 units on a scale |
| Active TENS | Tampa Scale of Kinesiophobia (17 to 68 Low to High) | Change at 8 weeks | -0.3 units on a scale |
| Placebo TENS | Tampa Scale of Kinesiophobia (17 to 68 Low to High) | Change at 4 weeks | -0.3 units on a scale |
| Placebo TENS | Tampa Scale of Kinesiophobia (17 to 68 Low to High) | Change at 8 weeks | -2.3 units on a scale |
| No TENS (Standard Care) | Tampa Scale of Kinesiophobia (17 to 68 Low to High) | Change at 4 weeks | -0.2 units on a scale |
| No TENS (Standard Care) | Tampa Scale of Kinesiophobia (17 to 68 Low to High) | Change at 8 weeks | -3.3 units on a scale |
Comparison: Visit 2 to Visit 3p-value: >0.9995% CI: [-2.3, 1.5]Linear mixed models for repeated measure
Comparison: Visit 2 to Visit 3p-value: >0.9995% CI: [-2.4, 1.3]Linear mixed models for repeated measure