N/A
N=301
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT01888640 ↗Enrolled (actual)
301
Serious AEs
0.6%
Results posted
Oct 2019
Primary outcome: Primary: Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test — -1.8; -0.8; 0.00; -2.0 Units on a scale — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TENS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kathleen Sluka
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test |
-1.8; -0.8; 0.00; -2.0; -1.9; -1.9 | 0.008 sig |
| PRIMARY Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test |
-1.6; -0.3; 0.2; -1.9; -1.4; -1.3 | 0.002 sig |
| SECONDARY Resting Pain (0-10 Low to High Scale) |
-1.9; -0.7; -0.5; -2.2; -1.9; -2.2 | 0.0006 sig |
| SECONDARY Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test |
-1.5; -0.1; 0.4; -1.3; -0.9; -0.9 | 0.001 sig |
| SECONDARY Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand |
-1.2; -0.0; 0.8; -1.1; -0.8; -0.6 | 0.011 sig |
| SECONDARY Resting Fatigue Rating (0-10 Low to High Scale) |
-1.9; -0.8; -0.4; -2.1; -1.6; -1.8 | 0.016 sig |
| SECONDARY Fibromyalgia Impact Questionnaire Revised |
-8.5; -3.4; -1.39; -9.6; -11.1; -10.7 | 0.074 |
| SECONDARY Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale) |
-1.3; -0.4; -0.1; -1.4; -1.2; -1.4 | 0.018 sig |
| SECONDARY Brief Pain Inventory - Interference (0-10 Low to High Scale) |
-0.9; -0.3; -0.3; -1.1; -0.9; -1.2 | 0.043 sig |
| SECONDARY Brief Pain Inventory, Intensity (0-10 Low to High Scale) |
-0.8; -0.3; 0.15; -1.0; -0.9; -0.9 | 0.036 sig |
| SECONDARY Tampa Scale of Kinesiophobia (17 to 68 Low to High) |
-0.7; -0.3; -0.2; -0.3; -2.3; -3.3 | >0.99 |
| SECONDARY Short Form Survey 36; Mental Component Score (T Score Mean of 50) |
2.3; 1.2; -0.04; 2.1; 3.6; 2.8 | >0.99 |
| SECONDARY Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health |
2.4; 1.2; 1.4; 3.5; 3.2; 4.4 | 0.36 |
| SECONDARY Six Minute Walk Test |
-1; -20; -42.1; 15; 16; -2 | >0.99 |
| SECONDARY Five Time Sit to Stand Test Rate Per 10 Seconds |
0.6; 0.4; 0.1; 0.6; 0.8; 0.6 | 0.96 |
| SECONDARY Moderate Vigorous Physical Activity Minutes Per Day |
-9.4; 2.5; -14.1; -6.8; -0.3; -17.0 | >0.99 |
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
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
Data sourced from ClinicalTrials.gov (NCT01888640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.