Conservative Treatment for Hip Osteoarthritis (COHART)
|ClinicalTrials.gov Identifier: NCT01039337|
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : March 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Hip||Other: Hip School Other: Hip School and Manual Treatment Other: Minimal control intervention||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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.
- Pain: Numerical pain scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
- Hip Disability and Osteoarthritis Outcome Score [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
- General improvement experienced by patient - "Global Assessment" [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
- Quality of life: EQ-5D [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
- Passive hip range of motion [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
- Hip surgery up to one year after baseline [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
- Use of pain medication [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
- Patient Specific Hip Disability [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039337
|Department of Ortopaedic Surgery and Traumatology, Odense University Hospital|
|Odense, DK, Denmark, 5000 C|
|Principal Investigator:||Erik Poulsen, DC, MSc||Nordic Institute of Chiropractic and Clinical Biomechanics|