The Effectiveness of Exercise Therapy and Manual Therapy in Hip Osteoarthritis - A Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale
研究概览
简要总结
Hip osteoarthritis is a major cause of disability and reduced quality of life. Physiotherapy, which encompasses a range of interventions such as exercise therapy, manual therapy, education and electrophysical agents, is a core component of management. To date, exercise therapy to date has the greatest evidence of effect . However, this evidence is limited as only a short-term benefit has been identified and improvements in pain and function decline over time. There is some limited evidence for a beneficial effect of manual therapy over exercise. However, clinically these interventions are used in combination, not in isolation. To date, no research has investigated the combined effect of exercise and manual therapy in hip OA.
A multi-centre randomised controlled trial that compares the clinical effectiveness of a combination of manual therapy and exercise to exercise therapy only will be conducted.
详细描述
A multi-centre RCT that evaluates the clinical effectiveness of two physiotherapy interventions for patients with osteoarthritis of the hip will be conducted The methodology will follow CONSORT (Consolidation of Standards of Reporting Trials) guidelines. Ethical approval for the study has been obtained from the Research Ethics Committees of the participating hospitals (Beaumont, St Vincent's University, Mater Misercordiae University Hospitals, Adelaide Meath Hospital Dublin, incorporating National Children's Hospital). Patients will be assessed at baseline, 9 weeks, (end of treatment) and 18 weeks. The treating therapists will be blinded to outcome assessments. Subjects cannot be blinded due to the nature of the interventions.
All patients with a diagnosis of Hip OA referred for physiotherapy from rheumatologists, GPs and orthopaedic consultants will be considered for inclusion into the RCT. Four similarly matched physiotherapy departments will be used: Beaumont Hospital (BH), St Vincent's University Hospital (SVUH) Adelaide Meath Hospital Dublin, incorporating National Children's Hospital) and Mater Misericordiae University Hospital (MMH).
Consenting subjects will be randomly allocated to one of 3 groups
- Exercise therapy (comprising strengthening, range of motion and aerobic exercise)
- Combined Exercise therapy and Manual Therapy
- Control group (Waiting List). These patients will remain on the waiting list for a 9 week period and will then be randomized to one of the two intervention groups.
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 (Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical criteria for the diagnosis of hip osteoarthritis (American College Rheumatology) (Altman et al, 1991):
- •Subjective complaint of hip pain with either hip internal rotation < 15 degrees and hip flexion <115 degrees or >15 degrees hip internal rotation and pain on hip internal rotation
- •morning stiffness less than or equal to 60 minutes, age > 50 years.
- •Age 40-80 years except in 2 above (age >50 years).
- •Radiological evidence of osteoarthritis (2 of the following 3 criteria):
- •osteophytes
- •joint space narrowing
- •ESR<20mm/hr (American College of Rheumatology Criteria for the Classification and Reporting of Osteoarthritis of the Hip)
- •Referred for physiotherapy
排除标准
- •Previous hip arthroplasty, history of congenital/adolescent hip disease
- •Clinical signs of lumbar spine disease
- •Physiotherapy in previous 6 months
- •Pregnancy
- •Hip fracture
- •Contraindications to exercise therapy
- •Contraindications to manual therapy
- •On waiting list for joint replacement within the next 18 weeks
- •Rheumatic diseases e.g. Rheumatoid Arthritis, Ankylosing Spondylitis, etc
- •Hip cortisone injection in previous 30 days
结局指标
主要结局
WOMAC (Western Ontario and McMaster Universities) Osteoarthritis Index Physical Function Subscale
时间窗: 0, 9, 18 weeks
次要结局
- Physiotherapy Out-Patient Survey for Patient Satisfaction(18 weeks)
- Numerical Rating Scale for Pain(0,9,18 weeks)
- WOMAC total score, pain and stiffness subscales(0,9,18 weeks)
- Global Assessment of Change- 7 Point Likert Scale(9,18 weeks)
- Hip Range of motion using goniometry(0,9,18 weeks)
- Short Form-36v2 (Quality of Life)(0,9,18 weeks)
- Hospital Anxiety and Depression Scale (HADS)(0,9,18 weeks)
- Medication Usage (pain diary and Medication Quantification Scale)(0,9,18 weeks)
- International Physical Activity Questionnaire (Short version)(0,9,18 weeks)
- Repeated sit to stand test(0,9,18 weeks)
- 50 foot walk test(0,9,18 weeks)