Self Soft Tissue Therapy for Fibromyalgia Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02881411
• Date of registration: 10/08/2016
• Prospective Registration: No
• Primary sponsor: University of the West of England
• Public title: Self Soft Tissue Therapy for Fibromyalgia Syndrome
• Scientific title: Self Soft Tissue Therapy for Fibromyalgia Syndrome; Randomised Controlled Feasibility Study
• Date of first enrolment: July 2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02881411
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: Rob M Grieve, PhD
• Affiliation: University of the West of England

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Fibromyalgia Syndrome

Intervention(s)

Other: Self-soft tissue therapy

Other: Fibromyalgia coping skills programme

Primary Outcome(s)

Pressure Pain Threshold (PPT)-Change is being assessed. [Time Frame: Baseline day 0, conclusion at 6 weeks and three months after conclusion]

Secondary Outcome(s)

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]

Range of Movement (ROM)-Change is being assessed. [Time Frame: Baseline day 0, conclusion at 6 weeks and three months after conclusion]

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]

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]

Secondary ID(s)

JMA/It

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Royal United Hospital Bath NHS Trust