Back to results

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) (FAST)

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

TENS

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring TENS, Fibromyalgia, Accelerometer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Iowa
Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

ActiveTENS

Placebo TENS

No TENS (Standard Care)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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 .

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

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

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

Full Information

NCT ID

NCT01888640

First Posted

June 13, 2013

Last Updated

October 7, 2019

Sponsor

Kathleen Sluka

Collaborators

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT01888640

Brief Title

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)

Acronym

FAST

Official Title

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 30, 2013 (Actual)

Primary Completion Date

April 2, 2018 (Actual)

Study Completion Date

April 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kathleen Sluka

Collaborators

Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

TENS, Fibromyalgia, Accelerometer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

301 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ActiveTENS

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo TENS

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

No TENS (Standard Care)

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

TENS

Other Intervention Name(s)

Empi Select Unit

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Resting Pain (0-10 Low to High Scale)

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Fibromyalgia Impact Questionnaire Revised

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Tampa Scale of Kinesiophobia (17 to 68 Low to High)

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health

Description

Time Frame

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

Title

Six Minute Walk Test

Description

Time Frame

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

Title

Five Time Sit to Stand Test Rate Per 10 Seconds

Description

Time Frame

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

Title

Moderate Vigorous Physical Activity Minutes Per Day

Description

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen A Sluka, PhD, PT

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leslie J. Crofford, MD

Organizational Affiliation

Vanderbilt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37262-2681

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

By publication

IPD Sharing 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.

Citations:

PubMed Identifier

16236028

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. doi: 10.1111/j.1471-4159.2005.03511.x. Epub 2005 Oct 17.

Results Reference

background

PubMed Identifier

19945354

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.

Results Reference

background

PubMed Identifier

21144659

Citation

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.

Results Reference

background

PubMed Identifier

21481649

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.

Results Reference

background

PubMed Identifier

21277840

Citation

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.

Results Reference

background

PubMed Identifier

19007541

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. doi: 10.1007/s11926-008-0080-z.

Results Reference

background

PubMed Identifier

18640807

Citation

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.

Results Reference

background

PubMed Identifier

19820222

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.

Results Reference

background

PubMed Identifier

19370629

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.

Results Reference

background

PubMed Identifier

25212518

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.

Results Reference

background

PubMed Identifier

35295526

Citation

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.

Results Reference

derived

PubMed Identifier

33230010

Citation

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.

Results Reference

derived

PubMed Identifier

33003107

Citation

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.

Results Reference

derived

PubMed Identifier

31738014

Citation

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.

Results Reference

derived

PubMed Identifier

30157911

Citation

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.

Results Reference

derived

PubMed Identifier

26979999

Citation

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.

Results Reference

derived

Links:

URL

https://labnodes.vanderbilt.edu/member/profile/id/10689

Description

Link for Dr. Crofford

URL

http://www.medicine.uiowa.edu/pt/pain/

Description

Dr. Kathleen Sluka

URL

http://www.nursing.uiowa.edu/faculty-staff/faculty-directory/rakelb

Description

Dr. Barb Rakel

URL

https://medicine.uiowa.edu/pt/

Description

Dr. Dana Dailey and Dr. Carol Vance

Learn more about this trial

Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)

We'll reach out to this number within 24 hrs