Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)

Fibromyalgia Clinical Trial

— FAST  

Official title:

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888640
• Other study ID #: 201110717
• Status: Completed
• Phase: N/A
• Start date: September 30, 2013
• Est. completion date: April 2, 2018

Study information

• Verified date: October 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: April 2, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• TENS
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

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Kathleen Sluka	Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Liebano RE, Rakel B, Vance CG, Walsh DM, Sluka KA. An investigation of the development of analgesic tolerance to TENS in humans. Pain. 2011 Feb;152(2):335-42. doi: 10.1016/j.pain.2010.10.040. Epub 2010 Dec 8. — View Citation

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. — View Citation

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. — View Citation

Pantaleão 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. — View Citation

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. — View Citation

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. Epub 2005 Oct 17. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;6:CD006142. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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	Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)
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: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)

External Links

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