Conservative Treatment for Hip Osteoarthritis (COHART)

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Other: Hip School; Other: Hip School and Manual Treatment; Other: Minimal control intervention

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 Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • DK
    • Odense, DK, Denmark, 5000 C
      • Department of Ortopaedic Surgery and Traumatology, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain: Numerical pain scale	Baseline, 6 weeks, 3 months, 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nordic Institute of Chiropractic and Clinical Biomechanics
• Collaborators: Odense University Hospital; University of Southern Denmark; Region of Southern Denmark; The Danish Rheumatism Association; Foundation for Chiropractic Research and Post Graduate Education
• Investigators: Principal Investigator: Erik Poulsen, DC, MSc, Nordic Institute of Chiropractic and Clinical Biomechanics

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 22, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (Estimate): December 24, 2009

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: osteoarthritis; patient education; manual therapy; manipulation; chiropractic; hip school
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: COHART; CVK S-20080027