Conservative Treatment for Hip Osteoarthritis

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect of manual treatment and a patient education programme for patients without indication for hip surgery.

Detailed Description
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Hip osteoarthritis (hip OA) is the second most common arthritis of the larger joints and may result in pain and disability and lead to reduced quality of life (QoL). The prevalence of hip OA, in the adult population, > 35 years, is estimated to 4-11% in the western society. In specific countries hip OA affects up to 25% in adults > 60 years. With a growing elder population, these prevalence rates will increase and the demand for cost-effective and safe interventions will increase as well. International guidelines, 2008, on the management of hip and knee OA recommend a combination of non-pharmacological and pharmacological treatment. For years the majority of interventional research for hip and knee OA has focused on surgery and drugs. Surgery is an option, when pain and disability have reached severe levels, and an increasing group of patients are today looking for other treatment options than drug treatment (pharmacological). In the last 4-6 years, new randomized controlled trials (RCT) have shown promising results with non-pharmacological treatment, such as exercise, patient education, manual therapy and acupuncture. The purpose of this RCT is to investigate the effect of combining manual treatment and a patient education programme and compare it to a minimal intervention in form of a home stretching programme. It will further investigate the specific effect of manual treatment.

Official Title
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Conservative Treatment for Hip Osteoarthritis: Effect of Manual Treatment and Hip School on Pain, Disability and Quality of Life - a Single-blinded Randomized Controlled Trial

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Other: Hip School
* Other: Hip School and Manual Treatment
* Other: Minimal control intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients referred from general practitioner, chiropractor or orthopaedic surgeon unilateral hip pain of minimum 3 months' duration radiology criteria for hip OA: joint space width (JSW) < 2.0 mm or a side difference in JSW of > 10% adequate mastering of the Danish language to complete instructions and questionnaires Exclusion Criteria: inflammatory joint disease previous hip or knee alloplastic secondary arthritis due to hip fracture or infection bilateral hip pain hip dysplasia with a CE angle > 25 degrees and an AA angle > 10 degrees low back pain which dominates over the hip pain malignant disease patients with paresis or paralysis after neuromuscular, cerebrovascular or polyneuropathic disease hip pain resulting from labral tear, bursitis and/or snapping hip syndrome polyarthritis received manual treatment for the hip within the last year

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hip school<br>This group will receive hip school during the intervention period of 6 weeks. | Other: Hip School<br>* The hip school consists of one initial personal interview, three group sessions, and one follow-up personal interview. The hip school is a patient education programme which involves anatomy/physiology, epidemiology, disease progression and pain, advice on self-help and exercises.<br>|
| Active Comparator: Hip School and Manual Treatment<br>This group receives both hip school and manual treatment during the 6 weeks. | Other: Hip School and Manual Treatment<br>* Hip school as above. Patients receive manual treatment twice a week for 6 weeks. Manual treatment consists of joint manipulation and muscle energy techniques to the articular and soft-tissue structures of the hip.<br>|
| Active Comparator: Minimal control intervention<br>An information leaflet including exercises. | Other: Minimal control intervention<br>* As control group, an information leaflet is used with instructions to live as usual during the 6 weeks intervention period. The exercise sheet of the hip school is given to the patients with no further instruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain: Numerical pain scale |  | Baseline, 6 weeks, 3 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Disability and Osteoarthritis Outcome Score |  | Baseline, 6 weeks, 3 months, 1 year | 
| General improvement experienced by patient - Global Assessment |  | Baseline, 6 weeks, 3 months, 1 year | 
| Quality of life: EQ-5D |  | Baseline, 6 weeks, 3 months, 1 year | 
| Passive hip range of motion |  | Baseline, 6 weeks, 3 months, 1 year | 
| Hip surgery up to one year after baseline |  | Baseline, 6 weeks, 3 months, 1 year | 
| Use of pain medication |  | Baseline, 6 weeks, 3 months, 1 year | 
| Patient Specific Hip Disability |  | Baseline, 6 weeks, 3 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, manual therapy, manipulation, hip school, chiropractic, patient education