Hip OsteoarthritisNCT01025661
Effects of Chiropractic Care in Patients With Hip Osteoarthritis
A study testing Chiropractic care in people with Hip Osteoarthritis, run by Scandinavian College of Chiropractic at 1 site in Sweden.
Trial summary
The purpose of the study is to explore the short term effects of chiropractic care on pain and function in patients with hip osteoarthritis. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Chiropractic care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- Start not givento not given
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- waiting for first time unilateral arthroplasty on the affected side
Who cannot join
- documented osteoporosis, current pathology such as malignancy, infection, cardiovascular disease, stroke and femoral fractures on affected side
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Scandinavian College of Chiropractic
Solna, Stockholm County, 169 57
About this study
Official title: Effects of Chiropractic Care on Pain and Function in Patients With Hip Osteoarthritis Waiting for Arthroplasty - a Controlled Clinical Pilot Trial
The purpose of the study is to explore the short term effects of chiropractic care on pain and function in patients with hip osteoarthritis.
Read the detailed description
Research over the last years have reported a scarce of trails investigating chiropractic treatment of lower extremities. Osteoarthritis, also called joint failure, is a common rheumatic joint disease often affecting the hipjoint, contributing to pain, decreased mobility and loss of function. Individuals with osteoarthritis can also be affected in many other ways, e.g. economically, socially and emotionally.
Chiropractic care may be considered as a complement to the conventional allopathic treatment of hip osteoarthritis. Joint manipulation is a well-established treatment technique to restore optimal joint function of the locomotor system. The aim of the study is to explore the effects of chiropractic vs. continued conventional care (waiting list controls) on pain and function during a three week trail period among patients with hip osteoarthritis waiting for arthroplasty.
- Conditions
- Hip Osteoarthritis
- Being tested
- Chiropractic care
- Keywords
- chiropractic, hip osteoarthritis, hip arthroplasty, pain, activities of daily living.
- Medical subject headings
- Osteoarthritis, Hip, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic careOther
Clinical examinations and treatments were performed at the outpatient clinic. The patients were assessed and treated by research assistants and the clinical care was supervised by state registered chiropractors. The choice of therapy and modality was pragmatic and based on the analysis of different functions such as mobility, tenderness, muscle tension and tone, and each patient's relative symptoms. Chiropractic care included high-velocity and low-amplitude techniques, soft-tissue or myofascial techniques, and arthrokinematic stabilizing exercises or a combination of these. Patients were treated in 1-2 sessions per week during the trial.
| Study group | Role | What they receive |
|---|---|---|
| Waiting list control | No intervention | The waiting list controls did not receive any intervention during the study period. Receives: Other: Chiropractic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 100mm Visual Analogue Scale (VAS)
Measured: Baseline and follow up after three weeks
Secondary outcomes (1)
The five sub-scales of the Hip disability and Osteoarthritis Outcome Score (HOOS), i.e. pain, other symptoms, function in daily living (ADL), function in sport and recreation (sport/rec) and hip related Quality of life (QOL)
Measured: Baseline and follow up after three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scandinavian College of Chiropractic
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Stockholm South General Hospital
- Investigators
- P M Thorman et al, RC, Principal investigator, Skandinavian College Of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025661
- Sponsor's protocol ID
- 2007/7900-31/3
- Status last verified
- Dec 2009
- First submitted
- 2 Dec 2009
- Last updated
- 8 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chiropractic Care on Pain and Function in Patients With Hip Osteoarthritis Waiting for Arthroplasty - a Controlled Clinical Pilot Trial
- ClinicalTrials.gov ID
- NCT01025661
- Acronym / sponsor ID
- 2007/7900-31/3
- Conditions
- Hip Osteoarthritis
- Keywords
- chiropractic, hip osteoarthritis, hip arthroplasty, pain, activities of daily living.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Scandinavian College of ChiropracticUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Stockholm South General Hospital
- First posted
- 3 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 explore the short term effects of chiropractic care on pain and function in patients with hip osteoarthritis.
Detailed description
Research over the last years have reported a scarce of trails investigating chiropractic treatment of lower extremities. Osteoarthritis, also called joint failure, is a common rheumatic joint disease often affecting the hipjoint, contributing to pain, decreased mobility and loss of function. Individuals with osteoarthritis can also be affected in many other ways, e.g. economically, socially and emotionally.
Chiropractic care may be considered as a complement to the conventional allopathic treatment of hip osteoarthritis. Joint manipulation is a well-established treatment technique to restore optimal joint function of the locomotor system. The aim of the study is to explore the effects of chiropractic vs. continued conventional care (waiting list controls) on pain and function during a three week trail period among patients with hip osteoarthritis waiting for arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Waiting list control | No intervention | Other: Chiropractic careThe waiting list controls did not receive any intervention during the study period. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- waiting for first time unilateral arthroplasty on the affected side
Key exclusion criteria (1 listed)
- documented osteoporosis, current pathology such as malignancy, infection, cardiovascular disease, stroke and femoral fractures on affected side
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 |
|---|---|---|
| Chiropractic careClinical examinations and treatments were performed at the outpatient clinic. The patients were assessed and treated by research assistants and the clinical care was supervised by state registered chiropractors. The choice of therapy and modality was pragmatic and based on the analysis of different functions such as mobility, tenderness, muscle tension and tone, and each patient's relative symptoms. Chiropractic care included high-velocity and low-amplitude techniques, soft-tissue or myofascial techniques, and arthrokinematic stabilizing exercises or a combination of these. Patients were treated in 1-2 sessions per week during the trial. | Other | Waiting list control |
Primary outcome
The 100mm Visual Analogue Scale (VAS)
Time frame: Baseline and follow up after three weeks
1 secondary outcome
The five sub-scales of the Hip disability and Osteoarthritis Outcome Score (HOOS), i.e. pain, other symptoms, function in daily living (ADL), function in sport and recreation (sport/rec) and hip related Quality of life (QOL)
Time frame: Baseline and follow up after three weeks
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 8 Dec 2009.
Related trials for Hip Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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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.
P M Thorman et al, RC principal investigator
Skandinavian College Of Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic care in people with Hip Osteoarthritis, run by Scandinavian College of Chiropractic at 1 site in Sweden.
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 1 inclusion and 1 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 8 Dec 2009. 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 Sweden. 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?
The 100mm Visual Analogue Scale (VAS) (time frame: Baseline and follow up after three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2009.