Conservative Treatment for Hip Osteoarthritis

Osteoarthritis, Hip Clinical Trial

— COHART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039337
• Other study ID #: COHART
• Secondary ID: CVK S-20080027
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: March 29, 2016
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2016
• Source: Nordic Institute of Chiropractic and Clinical Biomechanics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Other:
• Hip School
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.
• Hip School and Manual Treatment
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.
• Minimal control intervention
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.

Locations

Country	Name	City	State
Denmark	Department of Ortopaedic Surgery and Traumatology, Odense University Hospital	Odense	DK

Sponsors (6)

Lead Sponsor	Collaborator
Nordic Institute of Chiropractic and Clinical Biomechanics	Foundation for Chiropractic Research and Post Graduate Education, Odense University Hospital, Region of Southern Denmark, The Danish Rheumatism Association, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: Numerical pain scale		Baseline, 6 weeks, 3 months, 1 year	No
Secondary	Hip Disability and Osteoarthritis Outcome Score		Baseline, 6 weeks, 3 months, 1 year	No
Secondary	General improvement experienced by patient - "Global Assessment"		Baseline, 6 weeks, 3 months, 1 year	No
Secondary	Quality of life: EQ-5D		Baseline, 6 weeks, 3 months, 1 year	No
Secondary	Passive hip range of motion		Baseline, 6 weeks, 3 months, 1 year	No
Secondary	Hip surgery up to one year after baseline		Baseline, 6 weeks, 3 months, 1 year	No
Secondary	Use of pain medication		Baseline, 6 weeks, 3 months, 1 year	No
Secondary	Patient Specific Hip Disability		Baseline, 6 weeks, 3 months, 1 year	No