Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000965505
Ethics application status
Not yet submitted
Date submitted
19/08/2015
Date registered
15/09/2015
Date last updated
22/11/2018
Date data sharing statement initially provided
22/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can combined exercise and manual therapy alter the need for surgery in patients with advanced osteoarthritis of the knee?
Scientific title
Can a supervised exercise programme with manual therapy improve pain, function and quality of life in patients with advanced OA knee?: A randomised controlled trial.
Secondary ID [1] 287317 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee joint. 295954 0
Condition category
Condition code
Musculoskeletal 296227 296227 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 296433 296433 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will attend the Physiotherapy Dept for a supervised exercise programme twice weekly. They will attend for 24 sessions of 1 hour each, delivered twice weekly over a 12 week intervention period. They will attend the gym and the hydrotherapy pool at SCGH. Patients will be part of a group doing 1 hour of land based and 1 hour of water based exercise classes each week. These will be supervised by a Physiotherapist.

The land/gym based exercise class will include a combination of balance and strength training using walking exercises, stepup and down exercises, theraband/elastic exercises, free weights and quadriceps machines and cycling. The pool exercise class will include a walking programme, stepping exercises, buoyancy assisted exercises for balance and specific water resisted leg strengthening exercises.

Once each fortnight they will also receive manual therapy from a post-graduate qualified (Musculoskeletal) Physiotherapist. Patients will receive a total of 6 sessions of 10 minutes duration each, over the 12 week intervention period, of manual therapy. This will include gliding techniques to the patella and soft tissue techniques to the surrounding muscles.

All patients will be registered for each session on an attendance sheet as per usual Physiotherapy Outpatient Department practice. Patient notes will also be completed on each occasion of service, including the date, treatment administered and type of exercise undertaken. These records wil be kept in accordance with the infrastructure already in place in the Department.
Intervention code [1] 292637 0
Treatment: Other
Intervention code [2] 292807 0
Rehabilitation
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 295891 0
Proportion of patients who achieve a decrease in pain score, assessed using the Numerical Rating Scale (NRS).
Timepoint [1] 295891 0
At baseline, 12 weeks and 6 months.
Primary outcome [2] 295892 0
Proportion of patients who achieve an improvement in function, assessed using the Western Ontario and McMaster osteoarthritis index (WOMAC).
Timepoint [2] 295892 0
Baseline, 12 weeks, 6 months.
Secondary outcome [1] 316871 0
Proportion of patients who achieve an improvement in quality of life using the SF-36 Health Survey.
Timepoint [1] 316871 0
Baseline, 12 weeks, 6 months.
Secondary outcome [2] 316872 0
Proportion of patients who achieve a delay in surgical need for Total Knee Replacement, using the Orthopaedic Dept Waitlist at SCGH catalogue of all current patients.
Timepoint [2] 316872 0
6 months and 12 months.

Eligibility
Key inclusion criteria
OA of the knee joint at a level of severity that the patient has been consented for a Total Knee Replacement (TKR), as a category 3. This means they will undergo surgery in less than 365 days.
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous TKR.
Listed for bilateral TKR.
Need for High Risk Anaesthetic assessment indicating significant medical comorbidities
Weight of greater than 120kg. The gym equipment in the Physiotherapy Dept is not certified as safe above this weight.
Open wounds and incontinence as patients are unable to participate in pool based exercise classes.

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)
Allocation was done by a process of central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Calculation:
Using a type 1 error rate of 5%, power of 80% and an expected standard deviation in the difference in WOMAC scores from pre- to post-treatment of 55 points, we require a sample size of 76 participants per group to detect a difference of 25 points in the mean pre-post differences of WOMAC scores between treatment and control groups. The target sample of 200 was decided upon to take into account potential drop outs from the study once it has commenced.

Statistical Analysis Plan:
Linear mixed models will be used to compare differences from pre- to post-treatment in WOMAC scores between the treatment and control groups. Fixed factors of group and time (pre-treatment vs. post-treatment) will be used along with a random effect of individual.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
2/11/2015
Actual
Date of last participant enrolment
Anticipated
1/03/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4226 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 10197 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 291881 0
Hospital
Name [1] 291881 0
Sir Charles Gairdner Hospital.
Country [1] 291881 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 290584 0
None
Name [1] 290584 0
Address [1] 290584 0
Country [1] 290584 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293390 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 293390 0
Second Floor, A Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands. WA 6009
Ethics committee country [1] 293390 0
Australia
Date submitted for ethics approval [1] 293390 0
31/08/2015
Approval date [1] 293390 0
Ethics approval number [1] 293390 0
2015-096

Summary
Brief summary
The aim of this study is to examine whether patients who are waiting on a surgical waitlist for Total Knee Replacement, can decrease pain by participating in regular supervised exercise, together with targeted manual therapy.
HYPOTHESIS: Patients with severe OA of the knee who participate in a Physiotherapy intervention programme will experience a reduction in knee pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59670 0
Mrs Louise Giglia-Smith
Address 59670 0
Advanced Practitioner Physiotherapist
Sir Charles Gairdner Hospital
Physiotherapy Dept
Hospital Avenue
Nedlands. WA 6009
Country 59670 0
Australia
Phone 59670 0
+61, 8, 9346 2035
Fax 59670 0
Email 59670 0
[email protected]
Contact person for public queries
Name 59671 0
Mrs Louise Giglia-Smith
Address 59671 0
Sir Charles Gairdner Hospital
Physiotherapy Dept
Hospital Avenue
Nedlands. WA 6009
Country 59671 0
Australia
Phone 59671 0
+61, 8, 9346 2035
Fax 59671 0
Email 59671 0
[email protected]
Contact person for scientific queries
Name 59672 0
Mrs Louise Giglia-Smith
Address 59672 0
Sir Charles Gairdner Hospital
Physiotherapy Dept
Hospital Avenue
Nedlands. WA 6009
Country 59672 0
Australia
Phone 59672 0
+61, 8, 9346 2035
Fax 59672 0
Email 59672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Will get further into the study and make that decision.


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
No additional documents have been identified.