Conservative Treatment for Hip Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis, Hip
• Interventions: Other: Minimal control intervention; Other: Hip School; Other: Hip School and Manual Treatment

• Registration Number: NCT01039337
• Lead Sponsor: Nordic Institute of Chiropractic and Clinical Biomechanics

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal control intervention	Minimal control intervention	An information leaflet including exercises.
Hip school	Hip School	This group will receive hip school during the intervention period of 6 weeks.
Hip School and Manual Treatment	Hip School and Manual Treatment	This group receives both hip school and manual treatment during the 6 weeks.

Primary Outcome Measures

Name	Time	Method
Pain: Numerical pain scale	Baseline, 6 weeks, 3 months, 1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ortopaedic Surgery and Traumatology, Odense University Hospital; 🇩🇰 Odense, DK, Denmark