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Trial registered on ANZCTR


Registration number
ACTRN12609000664246
Ethics application status
Approved
Date submitted
3/08/2009
Date registered
5/08/2009
Date last updated
5/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of chiropractic management for the lower limb kinetic chain in sufferers of hip osteoarthritis
Scientific title
Sufferers of hip osteoarthritis receiving chiropractic management of the lower limb kinetic chain and their changes in overall therapy effectiveness and the Western Ontario and McMaster Universities Osteoarthritis Index.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 243448 0
Condition category
Condition code
Alternative and Complementary Medicine 239747 239747 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-adjustive stretches of hip musculature and hip manipulation, as well as an intervention group which received stretching and manipulation of the lumbar spine, sacro-iliac joints and ipsilateral knee, ankle and foot complexes.

receiving
Treatment was provided by a senior chiropractic intern, with treatment scheduled two time per week for nine visits, and then six additional optional treatments over six months. Treatment usually lasted for 15-30 minutes.
Intervention code [1] 237066 0
Treatment: Other
Intervention code [2] 237077 0
Rehabilitation
Comparator / control treatment
Stretching and manipulation of the symtomatic hip only

Treatment was provided by a senior chiropractic intern, with treatment scheduled two time per week for nine visits, and then six additional optional treatments over six months. Treatment usually lasted for 15-30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 240503 0
McMaster Overall Therapy Effectiveness
Timepoint [1] 240503 0
On the conclusion of nine treatment sessions, after three months, six months and nine months.
Primary outcome [2] 240504 0
Western Ontario and McMaster Universities Osteoarthritis Index
Timepoint [2] 240504 0
On the conclusion of nine treatment sessions, after three months, six months and nine months.
Secondary outcome [1] 257059 0
Berg Balance Scale
Timepoint [1] 257059 0
On the conclusion of nine treatment sessions, after three months, six months and nine months.
Secondary outcome [2] 257060 0
Goniometry measurements (range of motion)
Timepoint [2] 257060 0
On the conclusion of nine treatment sessions, after three months, six months and nine months.

Eligibility
Key inclusion criteria
Meeting the American College of Rheumatology clinical criteria for hip osteoarthritis and having recent x-rays graded as having Grade 1 to 3 hip osteoarthritis as per the Kellgren and Lawrence radiological assessment of osteoarthritis.
Minimum age
55 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.      Patient report of general and internal medical disorders such as significant visual disorders, severe vestibular disorders (i.e., Meniere’s), neurological (Alzheimer’s and other degenerative brain and mental disorders, disease and dysfunction) and peripheral sensory disorders (severe insulin dependent diabetes),
2.      History of hip joint replacement, rheumatoid arthritis, instability, fracture/ and severe osteoporosis, frank avascular necrosis with or without moderate or severe deformity,
3.      History of lumbar herniated disc and injury,
4.      Severe balance and proprioception problems (i.e., inability to stand with and/or without marked spinal or hip deformity) etc.,
5.      Symptoms of hip osteoarthritis (moderate to severe) in both hips,
6.      Marked or severe fear of chiropractic adjustments/manipulative and or exercise procedures.

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)
Interested individuals responded to an advertising campaign calling for sufferers of hip pain. They underwent initial phone screening to exclude sufferers of systemic conditions or contraindications to manipulative therapy. Subjects were included if they met the inclusion and possessed no exclusion criteria. Eligible participants were randomly allocated to one of two intervention groups; Protocol A or Protocol B. A random number generator was utilised to randomly sequence the two groups in allocations of six at a time.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1997 0
2122
Recruitment postcode(s) [2] 1998 0
2130

Funding & Sponsors
Funding source category [1] 237441 0
University
Name [1] 237441 0
Macquarie University
Address [1] 237441 0
Macquarie Injury Management Group, Macquarie University
Sydney, NSW 2109, Australia
Country [1] 237441 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Macquarie Injury Management Group
Address
C/o PO Box 448,
Cronulla, NSW 2230, Australia
Country
Australia
Secondary sponsor category [1] 236931 0
Individual
Name [1] 236931 0
Katie Hardy
Address [1] 236931 0
32 Elizabeth St
Parramatta, NSW 2150 Australia
Country [1] 236931 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239569 0
Macquarie University Human ethics Committee
Ethics committee address [1] 239569 0
Macquarie University
Sydney, NSW 2109, Australia
Ethics committee country [1] 239569 0
Australia
Date submitted for ethics approval [1] 239569 0
Approval date [1] 239569 0
22/02/2008
Ethics approval number [1] 239569 0
HE22FEB2008-R05639

Summary
Brief summary
This study aims to investigate the effectiveness of chiropractic treatment for the lower limb kinetic chian. We hypothesize the wider scope of treatment will provide better outcome in pain scores, overall effectiveness, range and motion and gait ability due to the inter-relationahip of the biomechanical change and addressing compensatory actions. We hope it will provide evidence to be included in guidelines for management of osteoarthritis and may provide alternative options to analgesics and surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30006 0
Address 30006 0
Country 30006 0
Phone 30006 0
Fax 30006 0
Email 30006 0
Contact person for public queries
Name 13253 0
Katie Hardy
Address 13253 0
135-139 Fairfield Rd
Guildford West NSW 2161
Country 13253 0
Australia
Phone 13253 0
+61 412 431 931
Fax 13253 0
Email 13253 0
katie_hardy@hotmail.com
Contact person for scientific queries
Name 4181 0
Henry Pollard
Address 4181 0
Macquarie Injury Management Group, Macquarie University
Sydney, NSW 2109, Australia
Country 4181 0
Australia
Phone 4181 0
+61 2 9523 4600
Fax 4181 0
Email 4181 0
hpollard@optushome.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary