Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000439044
Ethics application status
Not yet submitted
Date submitted
14/05/2010
Date registered
1/06/2010
Date last updated
1/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a physiotherapy program on pain and physical function in individuals with hip joint osteoarthritis.
Scientific title
The effects of a physiotherapy program on pain and physical function in individuals with hip joint osteoarthritis: a randomised, double-blind, placebo-controlled trial.
Secondary ID [1] 251853 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 252361 0
Condition category
Condition code
Musculoskeletal 256548 256548 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 257599 257599 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multimodal physiotherapy program, involving manual therapy, exercise and advice, delivered by experienced musculoskeletal Physiotherapists. There will be 10 treatment sessions over 12 weeks. The initial two sessions are 45 minutes each with subsequent sessions 30 minutes each. In order not to unblind potential participants, we are unable to provide a description of the physiotherapy program.
Intervention code [1] 255669 0
Rehabilitation
Intervention code [2] 256545 0
Treatment: Other
Comparator / control treatment
Participants allocated to the sham physiotherapy group will receive realistic 'sham' physiotherapy treatment (inactive ultrasound and inert gel) that does not address the modifiable impairments seen in hip osteoarthritis. There will be 10 treatment sessions over 12 weeks. The initial two sessions are 45 minutes each with subsequent sessions 30 minutes each. In order not to unblind potential participants, we are unable to provide a description of the sham physiotherapy program.
Control group
Placebo

Outcomes
Primary outcome [1] 253429 0
The primary outcome will be hip pain measured using visual analog scale.
Timepoint [1] 253429 0
This will be administered at baseline, 12 weeks and 9 months (6 months post treatment).
Primary outcome [2] 253430 0
Self report physical function- Western Ontario and McMasters Universities (WOMAC) Osteoarthritis Index
Timepoint [2] 253430 0
This will be administered at baseline, 12 weeks and 9 months (6 months post treatment).
Secondary outcome [1] 262553 0
Health-related quality of life- The Assessment of Quality of Life (AQoL) instrument.
Timepoint [1] 262553 0
These will be administered at baseline, 12 weeks and 9 months (6 months post treatment).
Secondary outcome [2] 262554 0
Participant perceived response to treatment (change in pain and physical function) on a 7 point ordinal scale
Timepoint [2] 262554 0
These will be administered at 12 weeks and 9 months.
Secondary outcome [3] 262555 0
Range of motion of the hip internal rotators, external rotators, abductors, flexors and extensors measured with a goniometer and averaged over two repetitions. Strength of the hip internal rotators, external rotators, abductors, flexors and extensors measured with a hand held force transducer with the best of two repetitions taken. Strength of the quadriceps and hamstrings measured with Isokinetic dynamometer, with the best of two repetitions taken. Functional tests, which include the Step Test (number of steps completed in 15 seconds), the time to ascend and descend a series of 5 steps (average of 2 repetitions), the number of times a person can stand-up and sit back down in 30 seconds, the Four Square Step Test which is the time taken to step feet in 4 separate squares clockwise and then anti-clockwise (average of two repetitions) and the time taken to walk 20m in a straight line (average of two repetitions). Gait analyses will also be performed using infrared cameras and force plates to obtain kinetic and kinematic gait data.
Timepoint [3] 262555 0
These will be administered at baseline and at 12 weeks.
Secondary outcome [4] 262556 0
Physical activity levels as measured by the Physical Activity Scale for the Elderly (PASE) questionnaire.
Timepoint [4] 262556 0
These will be administered at baseline, 12 weeks and 9 months (6 months post treatment).
Secondary outcome [5] 262557 0
Adverse effects by use of open ended questions asked by physiotherapists and by the project examiner. Possible adverse events include delayed onset muscle soreness or increased hip pain.
Timepoint [5] 262557 0
These will be administered at 12 weeks.
Secondary outcome [6] 262558 0
Success of blinding- participants will nominate participant's group allocation.
Timepoint [6] 262558 0
These will be administered at 12 weeks and 9 months.
Secondary outcome [7] 262559 0
Direct health care costs, as measured by a recall questionnaire of all use of health professionals, medical tests, medications, professional home care and hospitalisation.
Timepoint [7] 262559 0
These will be administered monthly from baseline for 9 months.
Secondary outcome [8] 262560 0
Daily number of steps using a pedometer.
Timepoint [8] 262560 0
These will be administered at baseline, 12 weeks and 9 months.

Eligibility
Key inclusion criteria
People with hip osteoarthritis aged greater than 50 years fulfilling American College of Rheumatology classification criteria and reporting average hip pain >3 on visual analogue scale (to ensure a minimal level of pain) will be recruited. Hip osteoarthritis (OA) is defined as pain in the groin or hip region on most days of the past month, in addition to joint space narrowing and femoral or acetabular osteophytes on x-ray.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are: (i) hip surgery within 6 months; (ii) awaiting hip joint replacement surgery due to the length of followup; (iii) current or past (within 3 months) oral or intra-articular corticosteroid use; (iv) systemic arthritic conditions; (v) history of hip or knee joint replacement or osteotomy; (vi) symptomatic knee OA or other muscular, joint or neurological condition affecting lower limb function; (vii) physiotherapy treatment or exercises specifically for hip and trunk in past 6 months; (viii) inability to walk unaided; (ix) unable to comply with protocol.

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)
Project Examiner A will conduct preliminary screening over the phone. A standardised hip x-ray will then be obtained. This will be used to determine eligibility and to grade osteoarthritis severity. Baseline testing will be performed following which the participant will be randomised into one of two groups: (i) physiotherapy or (ii) sham physiotherapy. The randomisation schedule will be prepared by the study biostatistician. To conceal randomisation, consecutively numbered, sealed, opaque envelopes will be used and maintained centrally. The envelopes will be kept in a locked location accessible only by a research administrator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by random permuted blocks stratified according to therapist (to control for therapist variation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2348 0
3053

Funding & Sponsors
Funding source category [1] 256147 0
Government body
Name [1] 256147 0
National Health and Medical Research Council (NHMRC)
Country [1] 256147 0
Australia
Primary sponsor type
University
Name
The University of Melbourne, School of Physiotherapy
Address
200 Berkeley St Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 251490 0
None
Name [1] 251490 0
Address [1] 251490 0
Country [1] 251490 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258245 0
Human Research Ethics Committee
Ethics committee address [1] 258245 0
University of Melbourne VIC 3010
Ethics committee country [1] 258245 0
Australia
Date submitted for ethics approval [1] 258245 0
13/11/2009
Approval date [1] 258245 0
Ethics approval number [1] 258245 0
0932812.1

Summary
Brief summary
This project primarily aims to investigate the efficacy of a physiotherapy program to treat hip joint osteoarthritis. Secondary aims are to assess changes in relevant musculoskeletal impairments with treatment, maintenance of treatment effects over 6 months and the cost-effectiveness of physiotherapy.
Primary hypothesis:
A 12-week multimodal physiotherapy program will result in significantly greater improvements in pain and physical function than sham physiotherapy immediately post-treatment in individuals with hip OA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30596 0
Address 30596 0
Country 30596 0
Phone 30596 0
Fax 30596 0
Email 30596 0
Contact person for public queries
Name 13843 0
Kim Bennell
Address 13843 0
Centre for Health, Exercise and Sports Medicine
School of Physiotherapy
The University of Melbourne
Victoria
Australia 3010
Country 13843 0
Australia
Phone 13843 0
+61 3 8344 4135
Fax 13843 0
+61 3 8344 3771
Email 13843 0
k.bennell@unimelb.edu.au
Contact person for scientific queries
Name 4771 0
Kim Bennell
Address 4771 0
Centre for Health, Exercise and Sports Medicine
School of Physiotherapy
The University of Melbourne
Victoria
Australia 3010
Country 4771 0
Australia
Phone 4771 0
+61 3 8344 4135
Fax 4771 0
+61 3 8344 3771
Email 4771 0
k.bennell@unimelb.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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