Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000681954
Ethics application status
Approved
Date submitted
17/03/2008
Date registered
6/07/2011
Date last updated
6/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Chiropractic manipulation for osteoarthritis of the hip.
Scientific title
Chiropractic manipulation for osteoarthritic hip pain for changes in pain, range of motion, quality of life, cost, and risk for falls in subjects with hip osteoarthritis
Secondary ID [1] 262562 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 2930 0
Condition category
Condition code
Alternative and Complementary Medicine 3069 3069 0 0
Other alternative and complementary medicine
Musculoskeletal 268373 268373 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A: will receive 9 manipulative therapy treatments (adjustments) to one area: the hip with pre-manipulative static and post active-assisted stretch of tight hip muscles. After the last (or 9th) treatment these patients will receive general advice and recommendations on managing hip osteoarthritis and how to gently and safely increase general exercise. Chiropractic treatment will be provided as one on one therapy, of 20 minutes duration, at a frequency of two time per week for the first four weeks.

Group B: will receive 9 treatments with manipulative therapy treatments (adjustments) to the entire kinetic chain (five areas): the lumbosacral, sacroiliac, hip, knee, ankle and foot joints with pre-manipulative static and post active-assisted stretch of tight hip muscles. Chiropractic treatment will be provided as one on one therapy, of 20 minutes duration, at a frequency of two time per week for the first four weeks.
Intervention code [1] 2662 0
Treatment: Other
Comparator / control treatment
Group A
Control group
Active

Outcomes
Primary outcome [1] 3952 0
Western Ontario and McMaster Universities Osteoarthritis Index (functional quality of life)
Timepoint [1] 3952 0
9th Treatment, 3 month, 6 month, 9 month
Secondary outcome [1] 6642 0
Overall Treatment Effect (OTE) (general improvement and patient satisfaction)
Timepoint [1] 6642 0
9th Treatment, 3 month, 6 month, 9 month
Secondary outcome [2] 6643 0
Harris Hip Score (osteoarthritis functional changes)
Timepoint [2] 6643 0
9th Treatment, 3 month, 6 month, 9 month
Secondary outcome [3] 6644 0
Berg Balance Scale (risk for falls)
Timepoint [3] 6644 0
9th Treatment, 3 month, 6 month, 9 month
Secondary outcome [4] 6645 0
Visual Analog Scale (pain) and long arm goniometry (range of motion)
Timepoint [4] 6645 0
9th Treatment, 3 month, 6 month, 9 month

Eligibility
Key inclusion criteria
Diagnosis is made based upon the American College of Rheumatology guidelines, daily hip pain and/or stiffness for > 60 mins, radiographic diagnosis of hip osteoarthritis made using the ACR guidelines, <15 internal rotation and < 115 flexion.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous hip surgery, visual/ vestibular/ neurological/ peripheral or sensory disorders, rheumatoid arthritis, severe osteoporosis, lumbar herniated disc.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will contact a research assistant in response to print advertisement. Particiapnst will then be telephone screened, upon passing they will be invited for a physical and radiographic screening. Upon the diagnosis of osteoarthritis participant will then be randomised into Group A or Group B by concealed allocation via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random Number generator by using a randomisation table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 612 0
2122
Recruitment postcode(s) [2] 792 0
2113

Funding & Sponsors
Funding source category [1] 3182 0
Self funded/Unfunded
Name [1] 3182 0
Henry Pollard
Country [1] 3182 0
Australia
Primary sponsor type
Individual
Name
Henry Pollard
Address
84 The Kingsway
Cronulla NSW 2230
Country
Australia
Secondary sponsor category [1] 2852 0
Other Collaborative groups
Name [1] 2852 0
Cleveland College of Chiropractic
Address [1] 2852 0
Cleveland Chiropractic College
590 North Vermont Avenue
Los Angeles, California 90004
Country [1] 2852 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5166 0
Macquarie University
Ethics committee address [1] 5166 0
Research Office
Level 3, Research HUB, Building C5C
Macquarie University
NSW 2109
Ethics committee country [1] 5166 0
Australia
Date submitted for ethics approval [1] 5166 0
Approval date [1] 5166 0
22/02/2008
Ethics approval number [1] 5166 0
HE22FEB2008-R05639

Summary
Brief summary
The primary purpose of this study was to investigate if chiropractic treatment for the entire lower limb kinetic chain (lumbar spine, hip, knee, ankle and foot joints) has better outcomes than treatment of the symptomatic hip alone. Our hypothesis is that full lower limb kinetic chain treatment is better for changes in pain, range of motion, quality of life and risk for falls in subjects with hip osteoarthritis. The intervention tested was chiropractic manipulation performed at one area (symptomatic osteoarthritic hip) versus chiropractic manipulation at various areas (ipsilateral lower limb kinetic chain).
Trial website
Trial related presentations / publications
Brantingham JW, Globe G, Cassa T, Globe D, de Luca K, Pollard H. Full kinetic chain manual and manipulative therapy plus exercise compared with targeted manual and manipulative therapy plus exercise for symptomatic osteoarthritis of the hip - a randomised clinical trial. In Press – Archives of Physical Medicine and Rehabilitation.

de Luca K, Pollard H, Brantingham J, Cassa T, Globe G. A randomised controlled trial of chiropractic management for the lower limb kinetic chain in sufferers of hip osteoarthritis: a protocol. In Press – Journal of Chiropractic Medicine.


Brantingham JW, Globe G, Cassa T, Globe D, de Luca K, Pollard H, Lee F, Bates C, Jensen M, Mayer S, Korporaal C. A single-group pre-test post-test design using full kinetic chain manipulative therapy with rehabilitation in the treatment of 27 patients with hip osteoarthritis. Journal of the American Chiropractic Association 2010; 47(6):8-26.

de Luca K, Pollard H, Brantingham J, Cassa T, Globe G. Chiropractic management of the kinetic chain for the treatment of hip osteoarthritis: an Australian case series. Journal of Manipulative and Physiological Therapeutics 2010; 33(6):474-9.

Brantingham J, Globe G, Cassa T, Globe D, de Luca K, Pollard H, et al. A single-group pre-test post-test design using full kinetic chain manipulative therapy with rehabilitation in the treatment of 18 patients with hip osteoarthritis. Journal of Manipulative and Physiological Therapeutics 2010; 33(6):445-57.
Public notes

Contacts
Principal investigator
Name 28440 0
Address 28440 0
Country 28440 0
Phone 28440 0
Fax 28440 0
Email 28440 0
Contact person for public queries
Name 11597 0
Henry Pollard
Address 11597 0
84 The Kingsway
Cronulla NSW 2230
Country 11597 0
Australia
Phone 11597 0
+61 2 9523 4600
Fax 11597 0
Email 11597 0
hpollard@optushome.com.au
Contact person for scientific queries
Name 2525 0
Henry Pollard
Address 2525 0
84 The Kingsway
Cronulla NSW 2230
Country 2525 0
Australia
Phone 2525 0
+61 2 9523 4600
Fax 2525 0
Email 2525 0
hpollard@optushome.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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