Conservative Treatment for Hip Osteoarthritis

NCT ID: NCT01039337

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-06-30

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.

Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hip school

This group will receive hip school during the intervention period of 6 weeks.

Group Type ACTIVE_COMPARATOR

Hip School

Intervention Type OTHER

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

This group receives both hip school and manual treatment during the 6 weeks.

Group Type ACTIVE_COMPARATOR

Hip School and Manual Treatment

Intervention Type OTHER

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

An information leaflet including exercises.

Group Type ACTIVE_COMPARATOR

Minimal control intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Foundation for Chiropractic Research and Post Graduate Education

OTHER

Sponsor Role collaborator

Region of Southern Denmark

OTHER

Sponsor Role collaborator

The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

Nordic Institute of Chiropractic and Clinical Biomechanics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erik Poulsen, DC, MSc

Role: PRINCIPAL_INVESTIGATOR

Nordic Institute of Chiropractic and Clinical Biomechanics

Locations

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Department of Ortopaedic Surgery and Traumatology, Odense University Hospital

Odense, DK, Denmark

Site Status

Countries

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Denmark

References

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Poulsen E, Hartvigsen J, Christensen HW, Roos EM, Vach W, Overgaard S. Patient education with or without manual therapy compared to a control group in patients with osteoarthritis of the hip. A proof-of-principle three-arm parallel group randomized clinical trial. Osteoarthritis Cartilage. 2013 Oct;21(10):1494-503. doi: 10.1016/j.joca.2013.06.009. Epub 2013 Jun 21.

Reference Type DERIVED
PMID: 23792189 (View on PubMed)

Poulsen E, Christensen HW, Roos EM, Vach W, Overgaard S, Hartvigsen J. Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: protocol for a three-armed randomized clinical trial. BMC Musculoskelet Disord. 2011 May 4;12:88. doi: 10.1186/1471-2474-12-88.

Reference Type DERIVED
PMID: 21542914 (View on PubMed)

Other Identifiers

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CVK S-20080027

Identifier Type: -

Identifier Source: secondary_id

COHART

Identifier Type: -

Identifier Source: org_study_id

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