Self Soft Tissue Therapy for Fibromyalgia Syndrome; Randomised Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pressure Pain Threshold (PPT)-Change is being assessed.
研究概览
简要总结
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.
详细描述
AIMS & OBJECTIVES
The main aims of this preliminary research are:
- To determine the feasibility of conducting a future larger study in terms of recruitment, randomisation, estimates of effect size, study protocol and procedure, intervention and outcome acceptability.
- To determine if combining SSTT (MTrP therapy) as an adjunct to the presently only provided usual care of hands off (rehabilitation and self-management programme) is feasible and acceptable to participants in this combined treatment approach to FMS.
METHOD
The multidisciplinary team includes researchers and health professionals who are actively involved in musculoskeletal therapy and research. This current randomised controlled feasibility study is supported by internal funding from the Faculty of Health & Applied Sciences, University of the West of England (UWE), Bristol. Ethics approval from NHS ethics/IRAS has been obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Self-soft tissue therapy (Other)
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.
干预措施: Fibromyalgia coping skills programme (Other)
结局指标
主要结局
Pressure Pain Threshold (PPT)-Change is being assessed.
时间窗: Baseline day 0, conclusion at 6 weeks and three months after conclusion
Algometry of myofascial trigger points
次要结局
- 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)
- 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)
- 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)