Conservative Treatment for Hip Osteoarthritis (COHART)

Tracking Information
First Submitted Date ICMJE	December 22, 2009
First Posted Date ICMJE	December 24, 2009
Last Update Posted Date	March 30, 2016
Study Start Date ICMJE	October 2008
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 9, 2011)	Pain: Numerical pain scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
Original Primary Outcome Measures ICMJE; (submitted: December 23, 2009)	Pain: Numerical pain scale [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]; Disability: Patient Specific Hip Disability [ Time Frame: Baseline, 6 weeks, 3 months, 1 year ]
Change History	Complete list of historical versions of study NCT01039337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 9, 2011)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: December 23, 2009)	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 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
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	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Osteoarthritis, Hip
Intervention ICMJE	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.; 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.; 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.
Study Arms	Active Comparator: Hip school This group will receive hip school during the intervention period of 6 weeks. Intervention: Other: Hip School; Active Comparator: Hip School and Manual Treatment This group receives both hip school and manual treatment during the 6 weeks. Intervention: Other: Hip School and Manual Treatment; Active Comparator: Minimal control intervention An information leaflet including exercises. Intervention: Other: Minimal control intervention
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.
* 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	Completed
Actual Enrollment ICMJE; (submitted: November 6, 2012)	118
Original Estimated Enrollment ICMJE; (submitted: December 23, 2009)	120
Actual Study Completion Date	June 2011
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Denmark
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01039337
Other Study ID Numbers ICMJE	COHART; CVK S-20080027
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Nordic Institute of Chiropractic and Clinical Biomechanics
Study Sponsor ICMJE	Nordic Institute of Chiropractic and Clinical Biomechanics
Collaborators ICMJE	University of Southern Denmark; Odense University Hospital; Foundation for Chiropractic Research and Post Graduate Education; Region of Southern Denmark; The Danish Rheumatism Association
Investigators ICMJE	Principal Investigator: Erik Poulsen, DC, MSc Nordic Institute of Chiropractic and Clinical Biomechanics
PRS Account	Nordic Institute of Chiropractic and Clinical Biomechanics
Verification Date	March 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP