FibromyalgiaTENS&FMNCT00932360

Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)

A study testing TENS in people with Fibromyalgia, run by Dana Dailey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Fibromyalgia
What is being tested?: TENS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Fibromyalgia diagnosis by a physician
History of cervical or lumbar pain

Who cannot join

TENS use in the last 5 years
Pacemaker
No use of opioids

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa - Physical Therapy and Rehabilitation Science
Iowa City, Iowa, 52242

Other trials in United States

About this study

Fibromyalgia as a clinical syndrome is defined by chronic widespread muscular pain, fatigue and tenderness with hyperalgesia to pressure over tender points. Pain associated with fibromyalgia can interfere with daily function, work, and social activities. Thus, 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. Although the etiology of fibromyalgia is unknown, there is clearly enhanced sensitization in the central nervous system pain pathways as demonstrating by decreases in pressure pain thresholds, reduced central inhibition, and enhanced temporal summation. Reducing pain in people with fibromyalgia would help increase the patient's ability to return to work, perform activities of daily living and thus improve the quality of life for the patient. Transcutaneous electrical nerve stimulation (TENS) is a modality utilized in physical therapy that delivers electrical stimulation through the skin and is used for both acute and chronic pain. TENS works by reducing central excitability and increasing central inhibition. Thus, the investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with Fibromyalgia (FM) will reduce pain, reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and reduce temporal summation and that this decrease in pain and/or central excitability will improve function. The primary aim of the study is to test the effectiveness of TENS on pain and central excitability in a crossover design study for patients with Fibromyalgia with random assignment to three treatments: no treatment control, placebo TENS and active high frequency TENS. A secondary aim is to test the effect of decreased pain and central excitability on function in patients with Fibromyalgia.

Read the detailed description

The study will be a simple crossover design with the following three treatments (1) active TENS, (2) placebo TENS or (3) no treatment control randomly assigned. Subjects will draw the order for treatments (A, B, and C) out of a bowl at the initial testing session. This will determine the order of the testing. Each subject will receive all 3 treatments in random order.

The following tools will be used to measure subject characteristics (Fibromyalgia Impact Questionnaire, Tampa Scale of Kinesiophobia), pain (McGill Pain Questionnaire and Visual Analogue Scale), central excitability (pressure pain thresholds, temporal summation and DNIC) and function (6 minute walk test, range of motion, sit to stand test).

Conditions: Fibromyalgia
Being tested: TENS
Keywords: Fibromyalgia, Transcutaneous Electrical Nerve Stimulation (TENS)
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TENSDevice
Also called Rehabilicare Maxima
Active TENS, Placebo TENS and No Treatment TENS

Study groups in NCT00932360
Study group	Role	What they receive
Active TENS Placebo TENS No TENS	Experimental	Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Receives: Device: TENS
Placebo TENS Active TENS No TENS	Experimental	Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Participants wore a TENS unit that was turned off for blinding of the outcome assessor Receives: Device: TENS
No TENS Active TENS Placebo TENS	Experimental	No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Receives: Device: TENS
Active TENS No TENS Placebo TENS	Experimental	Active TENS: 100 Hz, 200 μs at maximal tolerable intensity No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Receives: Device: TENS
Placebo TENS No TENS Active TENS	Experimental	Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Receives: Device: TENS
No TENS Placebo TENS Active TENS	Experimental	No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Receives: Device: TENS

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain at Rest Difference Score Pre-intervention and Post Intervention
Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.
Measured: 3 weeks
Pain With Movement Difference Score Pre-intervention and Post Intervention
Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.
Measured: 3 weeks

Secondary outcomes (6)

Fatigue at Rest Difference Score Pre-intervention and Post Intervention
Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.
Measured: 3 weeks
Fatigue With Movement Difference Score Pre-intervention and Post Intervention
Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.
Measured: 3 weeks
PPT Cervical Region
Pressure pain threshold cervical region (kPa)
Measured: 3 weeks
PPT Lumbar Region
Pressure pain threshold in lumbar region (kPa)
Measured: 3 weeks
PPT for Anterior Tibialis
Pressure pain threshold in leg (kPa)
Measured: 3 weeks
6 Minute Walk Test Average Change (Feet)
6 minute walk test average change (feet) before and after intervention
Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Jun 2012

First posted3 Jul 2009 (estimated)
Study startJun 2009
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00932360
Sponsor's protocol ID: 200903744
Acronym: TENS&FM
Status last verified: Jan 2019
First submitted: 23 Jun 2009
Last updated: 16 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: See Publication listed for data

Publications

Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
PubMed 23900134

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)
ClinicalTrials.gov ID: NCT00932360
Acronym / sponsor ID: TENS&FM / 200903744
Conditions: Fibromyalgia
Keywords: Fibromyalgia, Transcutaneous Electrical Nerve Stimulation (TENS)
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Dana DaileyUniversity, hospital or other
Collaborators: American Physical Therapy Association
Study start: Jun 2009
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 3 Jul 2009 (estimated)
Results: Posted 10 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Active TENS Placebo TENS No TENS	Experimental	Device: TENSActive TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor
Placebo TENS Active TENS No TENS	Experimental	Device: TENSPlacebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Participants wore a TENS unit that was turned off for blinding of the outcome assessor
No TENS Active TENS Placebo TENS	Experimental	Device: TENSNo TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off
Active TENS No TENS Placebo TENS	Experimental	Device: TENSActive TENS: 100 Hz, 200 μs at maximal tolerable intensity No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off
Placebo TENS No TENS Active TENS	Experimental	Device: TENSPlacebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity
No TENS Placebo TENS Active TENS	Experimental	Device: TENSNo TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Fibromyalgia diagnosis by a physician
History of cervical or lumbar pain

Key exclusion criteria (3 listed)

TENS use in the last 5 years
Pacemaker
No use of opioids

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TENSAlso: Rehabilicare MaximaActive TENS, Placebo TENS and No Treatment TENS	Device	Active TENS No TENS Placebo TENS, Active TENS Placebo TENS No TENS, No TENS Active TENS Placebo TENS, No TENS Placebo TENS Active TENS, Placebo TENS Active TENS No TENS, Placebo TENS No TENS Active TENS

Primary outcome

Pain at Rest Difference Score Pre-intervention and Post Intervention
Time frame: 3 weeks
Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.
Pain With Movement Difference Score Pre-intervention and Post Intervention
Time frame: 3 weeks
Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.

6 secondary outcomes

Fatigue at Rest Difference Score Pre-intervention and Post Intervention
Time frame: 3 weeks
Fatigue With Movement Difference Score Pre-intervention and Post Intervention
Time frame: 3 weeks
PPT Cervical Region
Time frame: 3 weeks
PPT Lumbar Region
Time frame: 3 weeks
PPT for Anterior Tibialis
Time frame: 3 weeks
6 Minute Walk Test Average Change (Feet)
Time frame: 3 weeks

Results and safety

Results posted to the registry on 10 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active TENS, Placebo TENS and No TENS	10	10
Active TENS No TENS Placebo TENS	6	6
Placebo TENS Active TENS No TENS	3	3
Placebo TENS No TENS Active TENS	13	13
No TENS Active TENS Placebo TENS	4	4
No TENS Placebo TENS Active TENS	7	7

Primary outcome: Pain at Rest Difference Score Pre-intervention and Post Intervention

Time frame: 3 weeks. Mean (Standard Error). Unit: units on a scale

Measure	Active TENS n = 43	Placebo TENS n = 43	No TENS n = 41
Value	0.38 (0.26)	-0.74 (0.25)	-0.47 (0.26)

Primary outcome: Pain With Movement Difference Score Pre-intervention and Post Intervention

Time frame: 3 weeks. Mean (Standard Error). Unit: score on a scale

Measure	Active TENS to No Treatment to Placebo (ANP) n = 43	Active TENS to Placebo to No Treatment (APN) n = 43	No Treatment to Active TENS to Placebo TENS (NAP) n = 41
Value	1.11 (0.26)	0.23 (0.26)	0.26 (0.25)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active TENS	0 of 43 (0%)	0 of 43 (0%)	0 of 43
Placebo TENS	0 of 43 (0%)	0 of 43 (0%)	0 of 43
No TENS	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Limitations and caveats (from the sponsor): 43 subjects were enrolled to the study and completed a treatment (Active TENS, Placebo TENS or No TENS) in a randomized order with a one week washout period between treatments. Results were analyzed by comparing the groups for outcome measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23900134Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
PubMed Link for full text articleLink provided by the sponsor.
Individual participant dataSharing planned: No. See Publication listed for data

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dana L Dailey, PT,PhD principal investigator

University of Iowa

Kathleen A Sluka, PhD study chair

University of Iowa

Barbara Rakel, PhD study chair

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TENS in people with Fibromyalgia, run by Dana Dailey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain at Rest Difference Score Pre-intervention and Post Intervention (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00932360, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.