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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
Sponsor:
Collaborator:
Royal United Hospital Bath NHS Trust
Information provided by (Responsible Party):
University of the West of England

Study Description
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Brief Summary:

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

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Information from the National Library of Medicine

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


Locations
United Kingdom
Royal National Hospital for Rheumatic Diseases (RNHRD)
Bath, NE Somerset, United Kingdom, BA1 1RL
Sponsors and Collaborators
University of the West of England
Royal United Hospital Bath NHS Trust
Investigators
Principal Investigator: Rob M Grieve, PhD University of the West of England
More Information
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Additional Information:
Randomization Tool  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of the West of England
ClinicalTrials.gov Identifier: NCT02881411     History of Changes
Other Study ID Numbers: JMA/It
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 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