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Self Soft Tissue Therapy for Fibromyalgia Syndrome
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Purpose
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 | Intervention |
|---|---|
| Fibromyalgia Syndrome | Other: Self-soft tissue therapy Other: Fibromyalgia coping skills programme |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Self Soft Tissue Therapy for Fibromyalgia Syndrome; Randomised Controlled Feasibility Study |
- 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
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2016 |
| Study Completion Date: | April 2017 |
| Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02881411
| United Kingdom | |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | University of the West of England |
| ClinicalTrials.gov Identifier: | NCT02881411 History of Changes |
| Other Study ID Numbers: |
JMA/It |
| Study First Received: | August 10, 2016 |
| Last Updated: | July 11, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The data of individual participants will be made available in the results section of a publication. Anonymous data will be presented in the form of descriptive statistics in table or text format. |
Keywords provided by University of the West of England:
|
self-soft tissue therapy trigger points feasibility study |
Additional relevant MeSH terms:
|
Syndrome Fibromyalgia Myofascial Pain Syndromes Disease Pathologic Processes |
Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on July 26, 2017