Self Soft Tissue Therapy for Fibromyalgia Syndrome

NCT02881411 | Completed

• 1 other identifier: JMA/It
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Keywords

self-soft tissue therapy; trigger points; feasibility study

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Threshold (PPT)-Change is being assessed.

  Algometry of myofascial trigger points

  Baseline day 0, conclusion at 6 weeks and three months after conclusion

Secondary Outcomes (4)

• Verbal Numerical Rating Scale-Verbal description of pain from 0-10-Change is being assessed

  Baseline day 0, conclusion at 6 weeks and three months after conclusion

• Range of Movement (ROM)-Change is being assessed.

  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.

  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

  Baseline day 0, conclusion at 6 weeks and three months after conclusion

Study Arms (2)

Self-soft tissue therapy

ACTIVE COMPARATOR

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

Fibromyalgia coping skills programme

ACTIVE COMPARATOR

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

Interventions

Self-soft tissue therapy OTHER

Manual therapy for the muscles in the upper or lower limbs.

Self-soft tissue therapy

Fibromyalgia coping skills programme OTHER

Exercise, education programme

Fibromyalgia coping skills programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the West of England: lead
• Royal United Hospital Bath NHS Trust: collaborator

Study Sites (1)

Royal National Hospital for Rheumatic Diseases (RNHRD)

Bath, NE Somerset, BA1 1RL, United Kingdom

Location

Related Publications (4)

• Grieve R, Barnett S, Coghill N, Cramp F. Myofascial trigger point therapy for triceps surae dysfunction: a case series. Man Ther. 2013 Dec;18(6):519-25. doi: 10.1016/j.math.2013.04.004. Epub 2013 Jun 5.

  PMID: 23756031 BACKGROUND

• Renan-Ordine R, Alburquerque-Sendin F, de Souza DP, Cleland JA, Fernandez-de-Las-Penas C. Effectiveness of myofascial trigger point manual therapy combined with a self-stretching protocol for the management of plantar heel pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2011 Feb;41(2):43-50. doi: 10.2519/jospt.2011.3504. Epub 2011 Jan 31.

  PMID: 21285525 BACKGROUND

• Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

  PMID: 2306288 BACKGROUND

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 BACKGROUND

Related Links

• Randomization Tool

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Rob M Grieve, PhD

  University of the West of England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 29, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)