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Completed

NCT Number: NCT01039337

Conservative Treatment for Hip Osteoarthritis

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ortopaedic Surgery and Traumatology, Odense University Hospital

Odense, DK, 5000 C, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip School

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

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

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.

Primary outcomes

  1. Pain: Numerical pain scale

    Time frame: Baseline, 6 weeks, 3 months, 1 year

Secondary outcomes

  1. Hip Disability and Osteoarthritis Outcome Score

    Time frame: Baseline, 6 weeks, 3 months, 1 year

  2. General improvement experienced by patient - "Global Assessment"

    Time frame: Baseline, 6 weeks, 3 months, 1 year

  3. Quality of life: EQ-5D

    Time frame: Baseline, 6 weeks, 3 months, 1 year

  4. Passive hip range of motion

    Time frame: Baseline, 6 weeks, 3 months, 1 year

  5. Hip surgery up to one year after baseline

    Time frame: Baseline, 6 weeks, 3 months, 1 year

  6. Use of pain medication

    Time frame: Baseline, 6 weeks, 3 months, 1 year

  7. Patient Specific Hip Disability

    Time frame: Baseline, 6 weeks, 3 months, 1 year

Sponsors and collaborators

Lead sponsor

Nordic Institute of Chiropractic and Clinical Biomechanics

Other

Collaborators

  • Foundation for Chiropractic Research and Post Graduate Education
  • Odense University Hospital
  • Region of Southern Denmark
  • The Danish Rheumatism Association
  • University of Southern Denmark

Registry information

Official study 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

Acronym: COHART

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 24, 2009
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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