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Trial registered on ANZCTR


Registration number
ACTRN12608000288325
Ethics application status
Approved
Date submitted
5/06/2008
Date registered
5/06/2008
Date last updated
27/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of physiotherapy on pain and physical function in people with arthritis affecting their kneecap
Scientific title
Effect of a 12-week multi-modal physiotherapy treatment on pain and physical function in people with patellofemoral osteoarthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral osteoarthritis 3230 0
Condition category
Condition code
Musculoskeletal 3397 3397 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be treated by an experienced physiotherapist, trained and proficient in the interventions. The treatment will be delivered in 8 sessions (30-60 minutes duration) over 12 weeks (1/week for 4 weeks, 1/fortnight for 8 weeks).
The physiotherapy treatment will consist of quadriceps muscle retraining, quadriceps and hip muscle strengthening, patellar taping, manual patellofemoral and soft tissue mobilization, hip muscle retraining and OA education. The treatment will be tailored according to each patient’s clinical presentation (eg strength, pain severity, swelling), presence of comorbidities (eg back and hip pain or pathology) and progressed based on individual response to exercise load, thus maximising the training effects.
Exercises will be supervised by the physiotherapist during each visit. A home exercise program will be prescribed, to be performed independently at home 4 times per week.
An exercise manual will be produced, with clear instructions and diagrams. Specific aspects of the treatment include:
For the remaining 6 months of the trial, participants will be required to continue with a home maintenance program. Compliance with the program will be monitored from the diary recordings of exercise completions, usual pain and medication use.
Intervention code [1] 2973 0
Treatment: Other
Comparator / control treatment
The control treatment is a physiotherapy led OA education. Participants allocated to this group will attend individualised health education sessions covering topics such as exercise, diet weight loss etc, provided by the physiotherapist with the same frequency as the physiotherapy sessions. For the remaining 6 months of the trial, participants will be required to complete a diary, recording usual pain and medication use.
Control group
Active

Outcomes
Primary outcome [1] 4293 0
Knee pain severity on aggravating activity (stairs or squat) (past week) on a 0-100mm horizontal visual analogue scale (VAS)
Timepoint [1] 4293 0
baseline and 12 weeks
Primary outcome [2] 4294 0
Physical function will be assessed on the physical function subscale of the Western Ontario MacMaster Universities (WOMAC) Osteoarthritis Index.
Timepoint [2] 4294 0
baseline and 12 weeks
Primary outcome [3] 238024 0
Participants will rate their perceived overall change in symptoms following treatment on a 5 point ordinal scale: 1-much improved, 2-improved, 3-no change, 4-worse, 5-much worse, giving a perceived global effect score
Timepoint [3] 238024 0
baseline and 12 weeks
Secondary outcome [1] 7231 0
Sport and Recreational Function and Knee Related Quality-Of-Life will be assessed using the relevant scales of the Knee Injury and Osteoarthritis Outcome Score.
Timepoint [1] 7231 0
baseline and 12 weeks
Secondary outcome [2] 7233 0
Observed functional tests including the step test, a timed stair ascent/descent task, and a chair rise test.
Timepoint [2] 7233 0
baseline and 12 weeks
Secondary outcome [3] 7234 0
Physical Activity Scale for the Elderly (PASE).
Timepoint [3] 7234 0
baseline and 12 weeks
Secondary outcome [4] 7235 0
Treatment expectation and self efficacy questionnaires
Timepoint [4] 7235 0
baseline and 12 weeks

Eligibility
Key inclusion criteria
To be included in the study, participants must fulfil the following criteria: (i) aged at least 40 years; (ii) anterior- or retro-patellar knee pain aggravated by at least two activities that load the PFJ (eg stair ambulation, squatting and/or rising from sitting); (iii) pain severity at least 4 on an 11 point numerical pain scale during aggravating activities; (iv) pain during these activities present on most days during the past month; (v) osteophyte grade at least grade 1 in the lateral PFJ compartment on skyline x-ray
Minimum age
40 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: (i) concomitant pain from other knee structures, hip or lumbar spine; (ii) current or previous physiotherapy for knee pain (prior 12 months); (iii) contra-indications to the treatments (eg tape allergy); (iv) recent knee injections (prior 3 months); (v) planned lower limb surgery in the following 6 months; (vi) body mass index more than 34 kg.m2; (vii) medial patellofemoral OA (osteophytes or joint space narrowing on a skyline x-ray) that is more severe than lateral patellofemoral OA; (viii) moderate to severe concomitant tibiofemoral OA (Kellgren and Lawrence grade more than grade 2 on an postero-anterior radiograph); (ix) knee or hip arthroplasty or osteotomy; (xi) physical inability to undertake testing procedures or; (x) other medical conditions, including arthritic conditions which could affect testing or treatment outcomes; (xi) inability to understand written and spoken English.

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)
Sealed opaque envelopes kept in central location and opened at time of treatment by central administrator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated (variable block sizes will be used). The schedule will be maintained centrally by one of the investigators
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
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)

Funding & Sponsors
Funding source category [1] 3456 0
Government body
Name [1] 3456 0
National Health and Medical Research Council Project Grant
Address [1] 3456 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 3456 0
Australia
Primary sponsor type
Individual
Name
Dr Kay M Crossley
Address
Department of Mechanical Engineering
Melbourne School of Engineering
The University of Melbourne
Country
Australia
Secondary sponsor category [1] 3101 0
Individual
Name [1] 3101 0
Dr Rana Hinman
Address [1] 3101 0
Centre for Health, Exercise and Sports Medicine
School of Physiotherapy
The University of Melbourne
Country [1] 3101 0
Australia
Secondary sponsor category [2] 3102 0
Individual
Name [2] 3102 0
Prof Bill Vicenzino
Address [2] 3102 0
Division of Physiotherapy,
School of Health and Rehabilitation Sciences,
University of Queensland.
Country [2] 3102 0
Australia
Secondary sponsor category [3] 3103 0
Individual
Name [3] 3103 0
Prof Marcus Pandy
Address [3] 3103 0
Department of Mechanical Engineering
Melbourne School of Engineering
The University of Melbourne
Country [3] 3103 0
Australia
Secondary sponsor category [4] 3104 0
Individual
Name [4] 3104 0
Dr Anthony Schache
Address [4] 3104 0
Department of Mechanical Engineering
Melbourne School of Engineering
The University of Melbourne
Country [4] 3104 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5489 0
Human Research Ethics Committee, The University of Melbourne
Ethics committee address [1] 5489 0
Level 5, Alan Gilbert Building
161 Barry Street
Carlton, 3052
Ethics committee country [1] 5489 0
Australia
Date submitted for ethics approval [1] 5489 0
Approval date [1] 5489 0
27/03/2008
Ethics approval number [1] 5489 0
0721163

Summary
Brief summary
Participants will be recruited from the community via advertisements, medical practitioners and our own research database.
Trial website
http://kneestudy.merit.unimelb.edu.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28647 0
Address 28647 0
Country 28647 0
Phone 28647 0
Fax 28647 0
Email 28647 0
Contact person for public queries
Name 11804 0
Dr Kay Crossley
Address 11804 0
Department of Mechanical Engineering
Melbourne School of Engineering
The University of Melbourne
Country 11804 0
Australia
Phone 11804 0
+61 38344 8646
Fax 11804 0
Email 11804 0
k.crossley@unimelb.edu.au
Contact person for scientific queries
Name 2732 0
Dr Kay Crossley
Address 2732 0
Department of Mechanical Engineering
Melbourne School of Engineering
The University of Melbourne
Country 2732 0
Australia
Phone 2732 0
+61 38344 8646
Fax 2732 0
Email 2732 0
k.crossley@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
No Results