Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)

NCT01888640 | Completed Results DMC FDA Device

• 1 other identifier: 201110717
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 2

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

Conditions

Fibromyalgia

Keywords

TENS; Fibromyalgia; Accelerometer

Outcome Measures

Primary Outcomes (2)

• 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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS

• 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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)

Secondary Outcomes (14)

• 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)

• 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 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)

• 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)

• 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)

Study Arms (3)

ActiveTENS

ACTIVE COMPARATOR

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.

Device: TENS

Placebo TENS

PLACEBO COMPARATOR

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.

Device: TENS

No TENS (Standard Care)

NO INTERVENTION

Participants 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.

Interventions

TENS DEVICE

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

Also known as: Empi Select Unit

ActiveTENS; Placebo TENS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathleen Sluka: lead
• Vanderbilt University: collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Vanderbilt University

Nashville, Tennessee, 37262-2681, United States

Location

Related Publications (16)

• Sluka KA, Vance CG, Lisi TL. High-frequency, but not low-frequency, transcutaneous electrical nerve stimulation reduces aspartate and glutamate release in the spinal cord dorsal horn. J Neurochem. 2005 Dec;95(6):1794-801. doi: 10.1111/j.1471-4159.2005.03511.x. Epub 2005 Oct 17.

  PMID: 16236028 BACKGROUND

• Rakel B, Cooper N, Adams HJ, Messer BR, Frey Law LA, Dannen DR, Miller CA, Polehna AC, Ruggle RC, Vance CG, Walsh DM, Sluka KA. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. J Pain. 2010 Mar;11(3):230-8. doi: 10.1016/j.jpain.2009.07.007. Epub 2009 Nov 27.

  PMID: 19945354 BACKGROUND

• Liebano RE, Rakel B, Vance CGT, Walsh DM, Sluka KA. An investigation of the development of analgesic tolerance to TENS in humans. Pain. 2011 Feb;152(2):335-342. doi: 10.1016/j.pain.2010.10.040. Epub 2010 Dec 8.

  PMID: 21144659 BACKGROUND

• Moran F, Leonard T, Hawthorne S, Hughes CM, McCrum-Gardner E, Johnson MI, Rakel BA, Sluka KA, Walsh DM. Hypoalgesia in response to transcutaneous electrical nerve stimulation (TENS) depends on stimulation intensity. J Pain. 2011 Aug;12(8):929-35. doi: 10.1016/j.jpain.2011.02.352. Epub 2011 Apr 9.

  PMID: 21481649 BACKGROUND

• Pantaleao MA, Laurino MF, Gallego NL, Cabral CM, Rakel B, Vance C, Sluka KA, Walsh DM, Liebano RE. Adjusting pulse amplitude during transcutaneous electrical nerve stimulation (TENS) application produces greater hypoalgesia. J Pain. 2011 May;12(5):581-90. doi: 10.1016/j.jpain.2010.11.001. Epub 2011 Feb 1.

  PMID: 21277840 BACKGROUND

• DeSantana JM, Walsh DM, Vance C, Rakel BA, Sluka KA. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep. 2008 Dec;10(6):492-9. doi: 10.1007/s11926-008-0080-z.

  PMID: 19007541 BACKGROUND

• Arnold LM, Crofford LJ, Mease PJ, Burgess SM, Palmer SC, Abetz L, Martin SA. Patient perspectives on the impact of fibromyalgia. Patient Educ Couns. 2008 Oct;73(1):114-20. doi: 10.1016/j.pec.2008.06.005. Epub 2008 Jul 21.

  PMID: 18640807 BACKGROUND

• Choy EH, Arnold LM, Clauw DJ, Crofford LJ, Glass JM, Simon LS, Martin SA, Strand CV, Williams DA, Mease PJ. Content and criterion validity of the preliminary core dataset for clinical trials in fibromyalgia syndrome. J Rheumatol. 2009 Oct;36(10):2330-4. doi: 10.3899/jrheum.090368.

  PMID: 19820222 BACKGROUND

• Walsh DM, Howe TE, Johnson MI, Sluka KA. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006142. doi: 10.1002/14651858.CD006142.pub2.

  PMID: 19370629 BACKGROUND

• Noehren B, Dailey DL, Rakel BA, Vance CG, Zimmerman MB, Crofford LJ, Sluka KA. Effect of transcutaneous electrical nerve stimulation on pain, function, and quality of life in fibromyalgia: a double-blind randomized clinical trial. Phys Ther. 2015 Jan;95(1):129-40. doi: 10.2522/ptj.20140218. Epub 2014 Sep 11.

  PMID: 25212518 BACKGROUND

• Chimenti RL, Rakel BA, Dailey DL, Vance CGT, Zimmerman MB, Geasland KM, Williams JM, Crofford LJ, Sluka KA. Test-Retest Reliability and Responsiveness of PROMIS Sleep Short Forms Within an RCT in Women With Fibromyalgia. Front Pain Res (Lausanne). 2021 Jun 8;2:682072. doi: 10.3389/fpain.2021.682072. eCollection 2021.

  PMID: 35295526 DERIVED

• Vance CGT, Zimmerman MB, Dailey DL, Rakel BA, Geasland KM, Chimenti RL, Williams JM, Golchha M, Crofford LJ, Sluka KA. Reduction in movement-evoked pain and fatigue during initial 30-minute transcutaneous electrical nerve stimulation treatment predicts transcutaneous electrical nerve stimulation responders in women with fibromyalgia. Pain. 2021 May 1;162(5):1545-1555. doi: 10.1097/j.pain.0000000000002144.

  PMID: 33230010 DERIVED

• Merriwether EN, Agalave NM, Dailey DL, Rakel BA, Kolker SJ, Lenert ME, Spagnola WH, Lu Y, Geasland KM, Allen LH, Burton MD, Sluka KA. IL-5 mediates monocyte phenotype and pain outcomes in fibromyalgia. Pain. 2021 May 1;162(5):1468-1482. doi: 10.1097/j.pain.0000000000002089.

  PMID: 33003107 DERIVED

• Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, Embree J, Merriwether EN, Geasland KM, Chimenti R, Williams JM, Golchha M, Crofford LJ, Sluka KA. Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial. Arthritis Rheumatol. 2020 May;72(5):824-836. doi: 10.1002/art.41170. Epub 2020 Mar 18.

  PMID: 31738014 DERIVED

• Merriwether EN, Frey-Law LA, Rakel BA, Zimmerman MB, Dailey DL, Vance CGT, Golchha M, Geasland KM, Chimenti R, Crofford LJ, Sluka KA. 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). Arthritis Res Ther. 2018 Aug 29;20(1):199. doi: 10.1186/s13075-018-1671-3.

  PMID: 30157911 DERIVED

• Dailey DL, Frey Law LA, Vance CG, Rakel BA, Merriwether EN, Darghosian L, Golchha M, Geasland KM, Spitz R, Crofford LJ, Sluka KA. Perceived function and physical performance are associated with pain and fatigue in women with fibromyalgia. Arthritis Res Ther. 2016 Mar 16;18:68. doi: 10.1186/s13075-016-0954-9.

  PMID: 26979999 DERIVED

Related Links

• Link for Dr. Crofford
• Dr. Kathleen Sluka
• Dr. Dana Dailey and Dr. Carol Vance

MeSH Terms

Conditions

Fibromyalgia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Kathleen A. Sluka
• Organization: University of Iowa

kathleen-sluka@uiowa.edu

319-335-9791

Study Officials

• Kathleen A Sluka, PhD, PT

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Leslie J. Crofford, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 28, 2013
• Study Start: September 30, 2013
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: October 31, 2019
• Results First Posted: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available by publication by April 2019 and for one year after closeout of the study and upon request with a proposed study protocol for 5 years.

Locations

US (2)