Conservative Treatment for Hip Osteoarthritis (COHART)

This study has been completed.
Sponsor:
Collaborators:
University of Southern Denmark
Odense University Hospital
Foundation for Chiropractic Research and Postgraduate Education
The Research Foundation for the Region of Southern Denmark
The Danish Rheumatism Association
Information provided by (Responsible Party):
Erik Poulsen, Nordic Institute of Chiropractic and Clinical Biomechanics
ClinicalTrials.gov Identifier:
NCT01039337
First received: December 22, 2009
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Osteoarthritis, Hip
Other: Hip School
Other: Hip School and Manual Treatment
Other: Minimal control intervention

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

Resource links provided by NLM:


Further study details as provided by Nordic Institute of Chiropractic and Clinical Biomechanics:

Primary Outcome Measures:
  • Pain: Numerical pain scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hip Disability and Osteoarthritis Outcome Score [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
  • General improvement experienced by patient - "Global Assessment" [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
  • Quality of life: EQ-5D [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
  • Passive hip range of motion [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
  • Hip surgery up to one year after baseline [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
  • Use of pain medication [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
  • Patient Specific Hip Disability [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hip school
This group will receive hip school during the intervention period of 6 weeks.
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.
Active Comparator: Hip School and Manual Treatment
This group receives both hip school and manual treatment during the 6 weeks.
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.
Active Comparator: Minimal control intervention
An information leaflet including exercises.
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039337

Locations
Denmark
Department of Ortopaedic Surgery and Traumatology, Odense University Hospital
Odense, DK, Denmark, 5000 C
Sponsors and Collaborators
Nordic Institute of Chiropractic and Clinical Biomechanics
University of Southern Denmark
Odense University Hospital
Foundation for Chiropractic Research and Postgraduate Education
The Research Foundation for the Region of Southern Denmark
The Danish Rheumatism Association
Investigators
Principal Investigator: Erik Poulsen, DC, MSc Nordic Institute of Chiropractic and Clinical Biomechanics
  More Information

No publications provided by Nordic Institute of Chiropractic and Clinical Biomechanics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erik Poulsen, PhD fellow, Nordic Institute of Chiropractic and Clinical Biomechanics
ClinicalTrials.gov Identifier: NCT01039337     History of Changes
Other Study ID Numbers: COHART, CVK S-20080027
Study First Received: December 22, 2009
Last Updated: November 6, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Nordic Institute of Chiropractic and Clinical Biomechanics:
osteoarthritis
manual therapy
manipulation
hip school
chiropractic
patient education

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014