Conservative Treatment for Hip Osteoarthritis (COHART)
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | December 22, 2009 | ||||
Last Updated Date | February 9, 2011 | ||||
Start Date ICMJE | October 2008 | ||||
Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Pain: Numerical pain scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01039337 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Conservative Treatment for Hip Osteoarthritis | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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 | 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 ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
||||
Condition ICMJE | Osteoarthritis, Hip | ||||
Intervention ICMJE |
|
||||
Study Arm (s) |
|
||||
Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 120 | ||||
Estimated Completion Date | June 2011 | ||||
Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 40 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Denmark | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01039337 | ||||
Other Study ID Numbers ICMJE | COHART, CVK S-20080027 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Erik Poulsen, DC, MSc, Nordic Institute of Chiropractic and Clinical Biomechanics | ||||
Study Sponsor ICMJE | Nordic Institute of Chiropractic and Clinical Biomechanics | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE |
|
||||
Information Provided By | Nordic Institute of Chiropractic and Clinical Biomechanics | ||||
Verification Date | February 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |