Self Soft Tissue Therapy for Fibromyalgia Syndrome
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|ClinicalTrials.gov Identifier: NCT02881411|
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : July 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Syndrome||Other: Self-soft tissue therapy Other: Fibromyalgia coping skills programme||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Self Soft Tissue Therapy for Fibromyalgia Syndrome; Randomised Controlled Feasibility Study|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Active Comparator: Self-soft tissue therapy
Intervention group: Fibromyalgia coping skills programme plus self-soft tissue therapy (SSTT) SSTT consists of MTrP therapy on TrP sites in either the lower leg/foot or forearm/hand. MTrP therapy will be administered by the researcher for only two sessions which will include training to teach the participant how to do SSTT on themselves. All participants in the intervention group will also receive an advice booklet for SSTT.
Other: Self-soft tissue therapy
Manual therapy for the muscles in the upper or lower limbs.
Active Comparator: Fibromyalgia coping skills programme
Control group:Fibromyalgia coping skills programme only. The FCSP is a non-pharmacological, multidisciplinary exercise and education group programme. Its main aims are to provide condition-specific, patient centred, self-management education and advice, in line with national drivers for long-term conditions and international FMS clinical guidelines.
Other: Fibromyalgia coping skills programme
Exercise, education programme
- Pressure Pain Threshold (PPT)-Change is being assessed. [ Time Frame: Baseline day 0, conclusion at 6 weeks and three months after conclusion ]Algometry of myofascial trigger points
- Verbal Numerical Rating Scale-Verbal description of pain from 0-10-Change is being assessed [ Time Frame: Baseline day 0, conclusion at 6 weeks and three months after conclusion ]Participants indicate the intensity of pain by reporting a number that best represents it, between 0 (no pain) and 10 (maximum pain).
- Range of Movement (ROM)-Change is being assessed. [ Time Frame: Baseline day 0, conclusion at 6 weeks and three months after conclusion ]Goniometric measurements for ankle and wrist
- Disabilities of Arm, Shoulder and Hand (DASH)-30-item, self-report questionnaire- Change is being assessed. [ Time Frame: Baseline day 0, conclusion at 6 weeks and three months after conclusion ]Is a validated standardised measure of physical function and symptoms in patients with musculoskeletal disorders of the upper limb.
- Lower Extremity Functional Scale (LEFS)-self-reported questionnaire (0-80 points)-Change is being assessed [ Time Frame: Baseline day 0, conclusion at 6 weeks and three months after conclusion ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881411
|Royal National Hospital for Rheumatic Diseases (RNHRD)|
|Bath, NE Somerset, United Kingdom, BA1 1RL|
|Principal Investigator:||Rob M Grieve, PhD||University of the West of England|