- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00932360
Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM) (TENS&FM)
Study Overview
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa - Physical Therapy and Rehabilitation Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fibromyalgia diagnosis by a physician
- History of cervical or lumbar pain
Exclusion Criteria:
- TENS use in the last 5 years
- Pacemaker
- No use of opioids
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active TENS Placebo TENS No TENS
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
|
Active TENS, Placebo TENS and No Treatment TENS
Other Names:
|
Experimental: Placebo TENS Active TENS No TENS
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
|
Active TENS, Placebo TENS and No Treatment TENS
Other Names:
|
Experimental: No TENS Active TENS Placebo TENS
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
|
Active TENS, Placebo TENS and No Treatment TENS
Other Names:
|
Experimental: Active TENS No TENS Placebo TENS
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
|
Active TENS, Placebo TENS and No Treatment TENS
Other Names:
|
Experimental: Placebo TENS No TENS Active TENS
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
|
Active TENS, Placebo TENS and No Treatment TENS
Other Names:
|
Experimental: No TENS Placebo TENS Active TENS
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
|
Active TENS, Placebo TENS and No Treatment TENS
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 weeks
|
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.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue at Rest Difference Score Pre-intervention and Post Intervention
Time Frame: 3 weeks
|
Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.
|
3 weeks
|
Fatigue With Movement Difference Score Pre-intervention and Post Intervention
Time Frame: 3 weeks
|
Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.
|
3 weeks
|
PPT Cervical Region
Time Frame: 3 weeks
|
Pressure pain threshold cervical region (kPa)
|
3 weeks
|
PPT Lumbar Region
Time Frame: 3 weeks
|
Pressure pain threshold in lumbar region (kPa)
|
3 weeks
|
PPT for Anterior Tibialis
Time Frame: 3 weeks
|
Pressure pain threshold in leg (kPa)
|
3 weeks
|
6 Minute Walk Test Average Change (Feet)
Time Frame: 3 weeks
|
6 minute walk test average change (feet) before and after intervention
|
3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dana L Dailey, PT,PhD, University of Iowa
- Study Chair: Kathleen A Sluka, PhD, University of Iowa
- Study Chair: Barbara Rakel, PhD, University of Iowa
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200903744
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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