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Trial record 6 of 138 for:    fibromyalgia | Open Studies | Interventional Studies

Self Soft Tissue Therapy for Fibromyalgia Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of the West of England
Sponsor:
Collaborator:
Royal United Hospital Bath NHS Trust
Information provided by (Responsible Party):
University of the West of England
ClinicalTrials.gov Identifier:
NCT02881411
First received: August 10, 2016
Last updated: August 26, 2016
Last verified: August 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self Soft Tissue Therapy for Fibromyalgia Syndrome; Randomised Controlled Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of the West of England:

Primary Outcome Measures:
  • Pressure Pain Threshold (PPT)-Change is being assessed. [ Time Frame: Baseline day 0, conclusion at 6 weeks and three months after conclusion ] [ Designated as safety issue: No ]
    Algometry of myofascial trigger points


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: April 2017
Estimated 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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02881411

Contacts
Contact: Rob M Grieve, PhD 00441173288896 Rob.Grieve@uwe.ac.uk
Contact: Leigh Taylor 0044117 328 1170 Leigh.Taylor@uwe.ac.uk

Locations
United Kingdom
Royal National Hospital for Rheumatic Diseases (RNHRD) Recruiting
Bath, NE Somerset, United Kingdom, BA1 1RL
Contact: Sandi Derham, MRes    00441225 473416    s.derham@nhs.net   
Contact: Julie Russell, BSc    00441225 473416    julie.russell19@nhs.net   
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

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: August 26, 2016
Health Authority: United Kingdom: Research Ethics Committee
Individual Participant Data  
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 September 29, 2016