NCT01888640: FAST

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)

Completed NA Results posted Last updated 31 October 2019

What this trial tests

NA trial testing TENS in Fibromyalgia in 301 participants. Completed in 2 April 2018.

Timeline

30 September 2013

Primary endpoint
2 April 2018

2 April 2018

Quick facts

Lead sponsor	Kathleen Sluka
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	301
Start date	30 September 2013
Primary completion	2 April 2018
Estimated completion	2 April 2018
Sites	2 locations across United States

Drugs / interventions tested

• TENS

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Kathleen Sluka

Who can join

Adults 18 to 70, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test Primary · 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 be

Change at 4 weeks

Group	Value	95% CI
Active TENS	-1.8	-2.3 – -1.2
Placebo TENS	-0.8	-1.4 – -0.2
No TENS (Standard Care)	0.00	-0.5 – 0.6

Change at 8 weeks

Group	Value	95% CI
Active TENS	-2.0	-2.8 – -1.3
Placebo TENS	-1.9	-2.7 – -1.2
No TENS (Standard Care)	-1.9	-2.6 – -1.2

Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test Primary · 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

Change at 4 weeks

Group	Value	95% CI
Active TENS	-1.6	-2.30 – -1.0
Placebo TENS	-0.3	-1.0 – 0.3
No TENS (Standard Care)	0.2	-0.4 – 0.9

Change at 8 weeks

Group	Value	95% CI
Active TENS	-1.9	-2.6 – -1.1
Placebo TENS	-1.4	-2.2 – -0.7
No TENS (Standard Care)	-1.3	-2.1 – -0.6

Resting Pain (0-10 Low to High Scale) Secondary · 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

Change at 4 weeks

Group	Value	95% CI
Active TENS	-1.9	-2.5 – -1.4
Placebo TENS	-0.7	-1.3 – -0.1
No TENS (Standard Care)	-0.5	-1.1 – 0.00

Change at 8 weeks

Group	Value	95% CI
Active TENS	-2.2	-2.9 – -1.6
Placebo TENS	-1.9	-2.6 – -1.2
No TENS (Standard Care)	-2.2	-2.8 – -1.5

Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test Secondary · 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

Change at 4 weeks

Group	Value	95% CI
Active TENS	-1.5	-2.2 – -0.8
Placebo TENS	-0.1	-0.9 – 0.7
No TENS (Standard Care)	0.4	-0.3 – 1.1

Change at 8 weeks

Group	Value	95% CI
Active TENS	-1.3	-2.0 – -0.6
Placebo TENS	-0.9	-1.7 – -0.2
No TENS (Standard Care)	-0.9	-1.7 – -0.2

Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand Secondary · 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

Change at 4 weeks

Group	Value	95% CI
Active TENS	-1.2	-1.9 – -0.5
Placebo TENS	-0.0	-0.8 – 0.7
No TENS (Standard Care)	0.8	0.1 – 1.5

Change at 8 weeks

Group	Value	95% CI
Active TENS	-1.1	-1.9 – -0.4
Placebo TENS	-0.8	-1.6 – -0.1
No TENS (Standard Care)	-0.6	-1.4 – 0.1

Resting Fatigue Rating (0-10 Low to High Scale) Secondary · 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

Change at 4 weeks

Group	Value	95% CI
Active TENS	-1.9	-2.6 – -1.2
Placebo TENS	-0.8	-1.5 – -0.04
No TENS (Standard Care)	-0.4	-1.0 – 0.4

Change at 8 weeks

Group	Value	95% CI
Active TENS	-2.1	-2.9 – -1.4
Placebo TENS	-1.6	-2.4 – -0.8
No TENS (Standard Care)	-1.8	-2.6 – -1.1

Fibromyalgia Impact Questionnaire Revised Secondary · 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

Change at 4 weeks

Group	Value	95% CI
Active TENS	-8.5	-12.9 – 4.0
Placebo TENS	-3.4	-6.5 – 0.3
No TENS (Standard Care)	-1.39	-4.4 – 1.6

Change at 8 weeks

Group	Value	95% CI
Active TENS	-9.6	-13.8 – 5.4
Placebo TENS	-11.1	-15.2 – 7.0
No TENS (Standard Care)	-10.7	-14.8 – -6.6

Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) Secondary · 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

Change at 4 weeks

Group	Value	95% CI
Active TENS	-1.3	-1.8 – -0.7
Placebo TENS	-0.4	-0.9 – -0.2
No TENS (Standard Care)	-0.1	-0.6 – 0.4

Change at 8 weeks

Group	Value	95% CI
Active TENS	-1.4	-2.0 – -0.8
Placebo TENS	-1.2	-1.7 – -0.6
No TENS (Standard Care)	-1.4	-1.9 – -0.8

Brief Pain Inventory - Interference (0-10 Low to High Scale) Secondary · 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 betw

Change at 4 weeks

Group	Value	95% CI
Active TENS	-0.9	-1.4 – -0.5
Placebo TENS	-0.3	-0.7 – 0.2
No TENS (Standard Care)	-0.3	-0.7 – 0.2

Change at 8 weeks

Group	Value	95% CI
Active TENS	-1.1	-1.6 – -0.6
Placebo TENS	-0.9	-1.4 – -0.3
No TENS (Standard Care)	-1.2	-1.7 – -0.7

Brief Pain Inventory, Intensity (0-10 Low to High Scale) Secondary · 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 betw

Change at 4 weeks

Group	Value	95% CI
Active TENS	-0.8	-1.1 – -0.4
Placebo TENS	-0.3	-0.6 – 0.1
No TENS (Standard Care)	0.15	-0.2 – 0.5

Change at 8 weeks

Group	Value	95% CI
Active TENS	-1.0	-1.4 – -0.6
Placebo TENS	-0.9	-1.3 – -0.5
No TENS (Standard Care)	-0.9	-1.2 – -0.5

Tampa Scale of Kinesiophobia (17 to 68 Low to High) Secondary · 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 gro

Change at 4 weeks

Group	Value	95% CI
Active TENS	-0.7	-2.0 – 0.6
Placebo TENS	-0.3	-1.7 – 1.0
No TENS (Standard Care)	-0.2	-1.4 – 1.1

Change at 8 weeks

Group	Value	95% CI
Active TENS	-0.3	-1.6 – 1.1
Placebo TENS	-2.3	-3.7 – -0.9
No TENS (Standard Care)	-3.3	-4.6 – -2.0

Short Form Survey 36; Mental Component Score (T Score Mean of 50) Secondary · 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 S

Change at 4 weeks

Group	Value	95% CI
Active TENS	2.3	0.2 – 4.4
Placebo TENS	1.2	-0.9 – 3.4
No TENS (Standard Care)	-0.04	-2.1 – 2.0

Change at 8 weeks

Group	Value	95% CI
Active TENS	2.1	-0.2 – 4.4
Placebo TENS	3.6	1.3 – 6.0
No TENS (Standard Care)	2.8	0.6 – 5.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Visit 1 to Visit 4, 9 weeks. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active TENS

Serious: 0/103 (0%)

Deaths: 0/103

Placebo TENS

Serious: 1/99 (1%)

Deaths: 0/99

No TENS (Standard Care)

Serious: 2/99 (2%)

Deaths: 0/99

Pre-Randomization

Serious: 1/352 (0%)

Deaths: 0/352

Serious adverse events (4 terms)

Reaction	System	Active TENS	Placebo TENS	No TENS (Standard Care)	Pre-Randomization
Chest pain	Cardiac disorders	—	—	—	—
Dehydration and gastrointestinal pain	Gastrointestinal disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Chest pain	Cardiac disorders	—	—	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Active TENS	Placebo TENS	No TENS (Standard Care)	Pre-Randomization
Pain with testing	Nervous system disorders	—	—	—	—
Upper Respiratory	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Upper Respiratory Infection	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Skin Irritation with Electrodes	Skin and subcutaneous tissue disorders	—	—	—	—
Pain with TENS; At home, unspecified	General disorders	—	—	—	—
Common Cold	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Fall	General disorders	—	—	—	—
Skin Irritation from actigraph band	Skin and subcutaneous tissue disorders	—	—	—	—
Headache or Migraine	General disorders	—	—	—	—
Dental Procedures	General disorders	—	—	—	—
Bladder Infection	Infections and infestations	—	—	—	—
Sinus Infection	Infections and infestations	—	—	—	—

Most-reported serious reactions: Chest pain, Dehydration and gastrointestinal pain, Depression, Chest pain.

Data from ClinicalTrials.gov NCT01888640 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial.
   Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, et al · · 2020 · cited 77× · PMID 31738014 · DOI 10.1002/art.41170
2. Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults.
   Johnson MI, Claydon LS, Herbison GP, Jones G, et al · · 2017 · cited 48× · PMID 28990665 · DOI 10.1002/14651858.cd012172.pub2
3. Reliability and Construct Validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments in Women with Fibromyalgia.
   Merriwether EN, Rakel BA, Zimmerman MB, Dailey DL, et al · · 2017 · cited 36× · PMID 27561310 · DOI 10.1093/pm/pnw187
4. Physical activity is related to function and fatigue but not pain in women with fibromyalgia: baseline analyses from the Fibromyalgia Activity Study with TENS (FAST).
   Merriwether EN, Frey-Law LA, Rakel BA, Zimmerman MB, et al · · 2018 · cited 34× · PMID 30157911 · DOI 10.1186/s13075-018-1671-3
5. Perceived function and physical performance are associated with pain and fatigue in women with fibromyalgia.
   Dailey DL, Frey Law LA, Vance CG, Rakel BA, et al · · 2016 · cited 34× · PMID 26979999 · DOI 10.1186/s13075-016-0954-9
6. Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial.
   Noehren B, Dailey DL, Rakel BA, Vance CG, et al · · 2015 · cited 32× · PMID 25212518 · DOI 10.2522/ptj.20140218
7. Remote Analgesic Effects Of Conventional Transcutaneous Electrical Nerve Stimulation: A Scientific And Clinical Review With A Focus On Chronic Pain.
   Gozani SN. · · 2019 · cited 29× · PMID 31819603 · DOI 10.2147/jpr.s226600
8. IL-5 mediates monocyte phenotype and pain outcomes in fibromyalgia.
   Merriwether EN, Agalave NM, Dailey DL, Rakel BA, et al · · 2021 · cited 28× · PMID 33003107 · DOI 10.1097/j.pain.0000000000002089