Conservative Treatment for Hip Osteoarthritis
COHART
2 other identifiers
interventional
118
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 22, 2009
CompletedFirst Posted
Study publicly available on registry
December 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMarch 30, 2016
March 1, 2016
2.7 years
December 22, 2009
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain: Numerical pain scale
Baseline, 6 weeks, 3 months, 1 year
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (3)
Hip school
ACTIVE COMPARATORThis group will receive hip school during the intervention period of 6 weeks.
Hip School and Manual Treatment
ACTIVE COMPARATORThis group receives both hip school and manual treatment during the 6 weeks.
Minimal control intervention
ACTIVE COMPARATORAn information leaflet including exercises.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nordic Institute of Chiropractic and Clinical Biomechanicslead
- University of Southern Denmarkcollaborator
- Odense University Hospitalcollaborator
- Foundation for Chiropractic Research and Post Graduate Educationcollaborator
- Region of Southern Denmarkcollaborator
- The Danish Rheumatism Associationcollaborator
Study Sites (1)
Department of Ortopaedic Surgery and Traumatology, Odense University Hospital
Odense, DK, 5000 C, Denmark
Related Publications (2)
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.
PMID: 23792189DERIVEDPoulsen 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.
PMID: 21542914DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik Poulsen, DC, MSc
Nordic Institute of Chiropractic and Clinical Biomechanics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2009
First Posted
December 24, 2009
Study Start
October 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 30, 2016
Record last verified: 2016-03