Conservative Treatment for Hip Osteoarthritis (COHART)
Primary Purpose
Osteoarthritis, Hip
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hip School
Hip School and Manual Treatment
Minimal control intervention
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring osteoarthritis, manual therapy, manipulation, hip school, chiropractic, patient education
Eligibility Criteria
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
Sites / Locations
- Department of Ortopaedic Surgery and Traumatology, Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Hip school
Hip School and Manual Treatment
Minimal control intervention
Arm Description
This group will receive hip school during the intervention period of 6 weeks.
This group receives both hip school and manual treatment during the 6 weeks.
An information leaflet including exercises.
Outcomes
Primary Outcome Measures
Pain: Numerical pain scale
Secondary Outcome Measures
Hip Disability and Osteoarthritis Outcome Score
General improvement experienced by patient - "Global Assessment"
Quality of life: EQ-5D
Passive hip range of motion
Hip surgery up to one year after baseline
Use of pain medication
Patient Specific Hip Disability
Full Information
NCT ID
NCT01039337
First Posted
December 22, 2009
Last Updated
March 29, 2016
Sponsor
Nordic Institute of Chiropractic and Clinical Biomechanics
Collaborators
University of Southern Denmark, Odense University Hospital, Foundation for Chiropractic Research and Post Graduate Education, Region of Southern Denmark, The Danish Rheumatism Association
1. Study Identification
Unique Protocol Identification Number
NCT01039337
Brief Title
Conservative Treatment for Hip Osteoarthritis
Acronym
COHART
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordic Institute of Chiropractic and Clinical Biomechanics
Collaborators
University of Southern Denmark, Odense University Hospital, Foundation for Chiropractic Research and Post Graduate Education, Region of Southern Denmark, The Danish Rheumatism Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
osteoarthritis, manual therapy, manipulation, hip school, chiropractic, patient education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hip school
Arm Type
Active Comparator
Arm Description
This group will receive hip school during the intervention period of 6 weeks.
Arm Title
Hip School and Manual Treatment
Arm Type
Active Comparator
Arm Description
This group receives both hip school and manual treatment during the 6 weeks.
Arm Title
Minimal control intervention
Arm Type
Active Comparator
Arm Description
An information leaflet including exercises.
Intervention Type
Other
Intervention Name(s)
Hip School
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hip School and Manual Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Minimal control intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain: Numerical pain scale
Time Frame
Baseline, 6 weeks, 3 months, 1 year
Secondary Outcome Measure Information:
Title
Hip Disability and Osteoarthritis Outcome Score
Time Frame
Baseline, 6 weeks, 3 months, 1 year
Title
General improvement experienced by patient - "Global Assessment"
Time Frame
Baseline, 6 weeks, 3 months, 1 year
Title
Quality of life: EQ-5D
Time Frame
Baseline, 6 weeks, 3 months, 1 year
Title
Passive hip range of motion
Time Frame
Baseline, 6 weeks, 3 months, 1 year
Title
Hip surgery up to one year after baseline
Time Frame
Baseline, 6 weeks, 3 months, 1 year
Title
Use of pain medication
Time Frame
Baseline, 6 weeks, 3 months, 1 year
Title
Patient Specific Hip Disability
Time Frame
Baseline, 6 weeks, 3 months, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Poulsen, DC, MSc
Organizational Affiliation
Nordic Institute of Chiropractic and Clinical Biomechanics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ortopaedic Surgery and Traumatology, Odense University Hospital
City
Odense
State/Province
DK
ZIP/Postal Code
5000 C
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23792189
Citation
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.
Results Reference
derived
PubMed Identifier
21542914
Citation
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.
Results Reference
derived
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Conservative Treatment for Hip Osteoarthritis
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