Osteoarthritis, HipCOHARTNCT01039337
Conservative Treatment for Hip Osteoarthritis
A study testing Hip School and Hip School and Manual Treatment in people with Osteoarthritis, Hip, run by Nordic Institute of Chiropractic and Clinical Biomechanics at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Hip School and Hip School and Manual Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ortopaedic Surgery and Traumatology, Odense University Hospital
Odense, DK, 5000 C
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Hip School, Hip School and Manual Treatment, Minimal control intervention
- Keywords
- osteoarthritis, manual therapy, manipulation, hip school, chiropractic, patient education
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip SchoolOther
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 and Manual TreatmentOther
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.
Minimal control interventionOther
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 group | Role | What they receive |
|---|---|---|
| Hip school | Active comparator | This group will receive hip school during the intervention period of 6 weeks. Receives: Other: Hip School |
| Hip School and Manual Treatment | Active comparator | This group receives both hip school and manual treatment during the 6 weeks. Receives: Other: Hip School and Manual Treatment |
| Minimal control intervention | Active comparator | An information leaflet including exercises. Receives: Other: Minimal control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: Numerical pain scale
Measured: Baseline, 6 weeks, 3 months, 1 year
Secondary outcomes (7)
Hip Disability and Osteoarthritis Outcome Score
Measured: Baseline, 6 weeks, 3 months, 1 year
General improvement experienced by patient - "Global Assessment"
Measured: Baseline, 6 weeks, 3 months, 1 year
Quality of life: EQ-5D
Measured: Baseline, 6 weeks, 3 months, 1 year
Passive hip range of motion
Measured: Baseline, 6 weeks, 3 months, 1 year
Hip surgery up to one year after baseline
Measured: Baseline, 6 weeks, 3 months, 1 year
Use of pain medication
Measured: Baseline, 6 weeks, 3 months, 1 year
Patient Specific Hip Disability
Measured: Baseline, 6 weeks, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Institute of Chiropractic and Clinical Biomechanics
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital, Foundation for Chiropractic Research and Post Graduate Education, Region of Southern Denmark, The Danish Rheumatism Association
- Responsible party
- Sponsor
- Investigators
- Erik Poulsen, DC, MSc, Principal investigator, Nordic Institute of Chiropractic and Clinical Biomechanics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039337
- Sponsor's protocol ID
- COHART
- Other IDs
- CVK S-20080027
- Acronym
- COHART
- Status last verified
- Mar 2016
- First submitted
- 22 Dec 2009
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23792189Poulsen 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.
PubMed 21542914
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01039337
- Acronym / sponsor ID
- COHART / COHART
- Conditions
- Osteoarthritis, Hip
- Keywords
- osteoarthritis, manual therapy, manipulation, hip school, chiropractic, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Nordic Institute of Chiropractic and Clinical BiomechanicsUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital, Foundation for Chiropractic Research and Post Graduate Education, Region of Southern Denmark, The Danish Rheumatism Association
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hip school | Active comparator | Other: Hip SchoolThis group will receive hip school during the intervention period of 6 weeks. |
| Hip School and Manual Treatment | Active comparator | Other: Hip School and Manual TreatmentThis group receives both hip school and manual treatment during the 6 weeks. |
| Minimal control intervention | Active comparator | Other: Minimal control interventionAn information leaflet including exercises. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip SchoolThe 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 |
| Hip School and Manual TreatmentHip 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 | Hip School and Manual Treatment |
| Minimal control interventionAs 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. | Other | Minimal control intervention |
Primary outcome
Pain: Numerical pain scale
Time frame: Baseline, 6 weeks, 3 months, 1 year
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Derived from this study: PubMed 23792189Poulsen 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.
- Derived from this study: PubMed 21542914Poulsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Poulsen, DC, MSc principal investigator
Nordic Institute of Chiropractic and Clinical Biomechanics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip School and Hip School and Manual Treatment in people with Osteoarthritis, Hip, run by Nordic Institute of Chiropractic and Clinical Biomechanics at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain: Numerical pain scale (time frame: Baseline, 6 weeks, 3 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039337, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.