Fibromyalgia Syndrome Clinical Trial
Official title:
Self Soft Tissue Therapy for Fibromyalgia Syndrome; Randomised Controlled Feasibility Study
Verified date | July 2017 |
Source | University of the West of England |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main aims of this preliminary research are to determine if combined self-soft tissue
therapy (SSTT) alongside an established 6 week FMS Coping Skills Programme (FCSP) is a
feasible and acceptable treatment approach for FMS. All participants on the six week FCSP
will be randomly allocated to a control (FMS Coping Skills Programme) or intervention group
(FMS Coping Skills Programme plus SSTT). All participants will be assessed for outcome
measurements at the start of the feasibility study, at six weeks and three months after
completion.
This feasibility study hypothesis is that the SST approach will be acceptable to FMS patients
and that the combined 6 week FCSP (hands off) and SSTT (hands on) will be beneficial. This
feasibility study will inform a larger randomized controlled trial (RCT) on this combined
treatment approach to FMS.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Aged over 18. Able be seated or lie prone for 30 minutes. Diagnosis or presentation of FMS and attending FMS coping skills programme. Complaint of forearm/hand or lower leg/foot pain or tenderness for the past 7 days.. No disorder apart from FMS, that would otherwise explain the pain or tenderness.. Exclusion criteria: Complex regional pain syndrome. Talipes equino varus, triple arthrodesis. Bony block of the ankle. Lower leg/foot injury. Forearm/hand injury. Diabetes. Peripheral vascular disease. Cancer. Rheumatoid arthritis or neurological impairment. Receiving physiotherapy or MTrP therapy to the upper or lower limb within the previous three months. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal National Hospital for Rheumatic Diseases (RNHRD) | Bath | NE Somerset |
Lead Sponsor | Collaborator |
---|---|
University of the West of England | Royal United Hospital Bath NHS Trust |
United Kingdom,
Grieve R, Barnett S, Coghill N, Cramp F. Myofascial trigger point therapy for triceps surae dysfunction: a case series. Man Ther. 2013 Dec;18(6):519-25. doi: 10.1016/j.math.2013.04.004. Epub 2013 Jun 5. — View Citation
Renan-Ordine R, Alburquerque-Sendín F, de Souza DP, Cleland JA, Fernández-de-Las-Peñas C. Effectiveness of myofascial trigger point manual therapy combined with a self-stretching protocol for the management of plantar heel pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2011 Feb;41(2):43-50. doi: 10.2519/jospt.2011.3504. Epub 2011 Jan 31. — View Citation
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140. — View Citation
Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pressure Pain Threshold (PPT)-Change is being assessed. | Algometry of myofascial trigger points | Baseline day 0, conclusion at 6 weeks and three months after conclusion | |
Secondary | Verbal Numerical Rating Scale-Verbal description of pain from 0-10-Change is being assessed | Participants indicate the intensity of pain by reporting a number that best represents it, between 0 (no pain) and 10 (maximum pain). | Baseline day 0, conclusion at 6 weeks and three months after conclusion | |
Secondary | Range of Movement (ROM)-Change is being assessed. | Goniometric measurements for ankle and wrist | Baseline day 0, conclusion at 6 weeks and three months after conclusion | |
Secondary | Disabilities of Arm, Shoulder and Hand (DASH)-30-item, self-report questionnaire- Change is being assessed. | Is a validated standardised measure of physical function and symptoms in patients with musculoskeletal disorders of the upper limb. | Baseline day 0, conclusion at 6 weeks and three months after conclusion | |
Secondary | Lower Extremity Functional Scale (LEFS)-self-reported questionnaire (0-80 points)-Change is being assessed | Is a validated standardised measure of lower limb function. A change in LEFS scores of 9 points or greater is a true change (CI 90%) and also a clinically meaningful functional change | Baseline day 0, conclusion at 6 weeks and three months after conclusion |
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