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Trial registered on ANZCTR


Trial ID
ACTRN12614000909628
Ethics application status
Approved
Date submitted
18/08/2014
Date registered
26/08/2014
Date last updated
7/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The CUBA Study - Cane Use and Bone marrow lesions in knee osteoArthritis
Scientific title
The CUBA Study: The impact of cane use on bone marrow lesion size in people with medial compartment knee osteoarthritis: a randomized controlled trial
Secondary ID [1] 285126 0
Nil
Universal Trial Number (UTN)
U1111-1160-1514
Trial acronym
CUBA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, knee 292683 0
Condition category
Condition code
Musculoskeletal 292998 292998 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 292999 292999 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: contra-lateral use of a cane to unload the affected medial knee compartment. Participants will be instructed to use the cane daily whenever walking for 3 months. Cane use and possible adverse events will be monitored in self-reported log books. Participants will receive reminders during the intervention to maximize adherence to cane use.
Intervention code [1] 289975 0
Treatment: Devices
Intervention code [2] 289976 0
Rehabilitation
Comparator / control treatment
Control Intervention:no use of any gait aids. Participants allocated to the control group will be instructed to maintain their normal lives and to not use any gait devices or gait aids for 3 months.
Control group
Active

Outcomes
Primary outcome [1] 292862 0
Bone marrow lesion size measured with MRI
Timepoint [1] 292862 0
Baseline and 3 months
Secondary outcome [1] 309818 0
Self-reported pain with the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC): pain sub-scale
Timepoint [1] 309818 0
Baseline and 3 months
Secondary outcome [2] 309819 0
Overall pain assessed with 11-point numeric rating scale
Timepoint [2] 309819 0
Baseline and 3 months
Secondary outcome [3] 309820 0
Health-related quality of life with Assessment of Quality of Life Instrument (AQol)
Timepoint [3] 309820 0
Baseline and 3 months
Secondary outcome [4] 309821 0
Participant-perceived overall global change (pain and physical function) since enrolling in the study with a 7-point scale
Timepoint [4] 309821 0
3 months
Secondary outcome [5] 309833 0
Self-reported physical function with the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC): physical function sub-scale
Timepoint [5] 309833 0
Baseline and 3 months
Secondary outcome [6] 309834 0
Additional measure - physical activity measured by the Physical Activity Scale for the Elderly (PASE)
Timepoint [6] 309834 0
Baseline and 3 months
Secondary outcome [7] 309835 0
Additional measure - physical activity measured by the number of steps taken during 1 week (7 days) wearing a pedometer attached to the participant's waist.
Timepoint [7] 309835 0
Baseline and 3 months
Secondary outcome [8] 309836 0
Additional measure - adverse events (eg increased knee pain, wrist pain, back pain etc) and co-interventions (eg analgetics, anti-inflammatories, physiotherapy etc) self-reported in logbooks and/or by questionnaire specifically designed for this study
Timepoint [8] 309836 0
Baseline, monthly and at 3 months
Secondary outcome [9] 309837 0
Additional measure - adherence to cane use measured by both self reported logbooks during the intervention and a questionnaire specifically designed for this study.
Timepoint [9] 309837 0
Weekly, monthly and at 3 months
Secondary outcome [10] 309838 0
'Additional measure - Feasibility and perceived barriers or benefits associated with cane use collected by questionnaire specifically designed for this study, Cane Use Cognitive Mediator Instrument and the NASA Task Load Index."
Timepoint [10] 309838 0
3 months
Secondary outcome [11] 310116 0
pain during walking assessed with 11-point numeric rating scale
Timepoint [11] 310116 0
baseline and 3 months
Secondary outcome [12] 315163 0
Additional measure - feasibility of the biofeedback cane training (eg level of difficulty, level of naturalness, usefulness of biofeedback, confidence in using biofeedback cane) and adverse events (eg symptoms at wrist, elbow, shoulder or neck due to using the biofeedback cane), measured using numeric rating scales in logbooks and/or questionnaires specifically designed for this study
Timepoint [12] 315163 0
Baseline, at week 1

Eligibility
Key inclusion criteria
Aged>50;
Knee pain on most days of the last month;
Kellgren-Lawrence grade 2 or above and definite medial tibiofemoral compartment OA on x-ray (grade 1 or higher medial joint space narrowing and joint space narrowing grade medial>lateral);
Presence of at least one bone marrow lesion in the medial knee compartment on MRI;
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of knee surgery ie joint replacement and tibial osteotomy in either knee and/or planning to undergo knee or hip surgery in the next 3 months;
Other muscular, joint, neurological conditions other than knee OA affecting lower limb function or interfering with daily cane use;
Current and previous (ie previous 3 months) use of canes; Current and previous (ie previous 3 months) irregular use of shoe inserts, knee or ankle braces or customized shoes prescribed by a health professional;
Current and previous treatments (ie previous 6 months) of knee arthroscopy and intra-articular injections in the knee;
Contra-indications for MRI;
Use of potential disease-modifying drugs;

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)
The person who will determine if a potential participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the participant will be allocated. After collection of baseline measures, participants will have 50% chance being allocated to either the control or the intervention group. Allocation will be concealed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the study biostatistician using random permuted blocks and stratified by Kellgren-Lawrence grading of disease severity and body mass index.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
1:1 allocation
Multi-site
Phase
Not Applicable
Type of endpoint(s)
Safety/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)
NSW,VIC
Recruitment hospital [1] 3886 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 4998 0
Maroondah Hospital - Ringwood East
Recruitment hospital [3] 4999 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 8513 0
3010 - University Of Melbourne
Recruitment postcode(s) [2] 8514 0
2006 - The University Of Sydney
Recruitment postcode(s) [3] 9779 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [4] 12486 0
3128 - Box Hill
Recruitment postcode(s) [5] 12487 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 289735 0
Government body
Name [1] 289735 0
National Health and Medical Research Council
Address [1] 289735 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 289735 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne
VIC 3010
Country
Australia
Secondary sponsor category [1] 288428 0
University
Name [1] 288428 0
University of Sydney
Address [1] 288428 0
The University of Sydney
NSW 2006
Country [1] 288428 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291470 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 291470 0
Melbourne Research
The University of Melbourne
Level 5, Alan Gilbert Building
VIC 3010
Ethics committee country [1] 291470 0
Australia
Date submitted for ethics approval [1] 291470 0
18/07/2014
Approval date [1] 291470 0
09/09/2014
Ethics approval number [1] 291470 0
1442016.1

Summary
Brief summary
Osteoarthritis (OA) is a major and costly cause of chronic musculoskeletal pain and disability in Australia. Patient self-management strategies are urgently needed. In knee OA, increased joint loading (forces acting across the joint) leads to worse knee pain and progressive structural joint deterioration. This project will investigate the impact of daily cane use, an easy and inexpensive self-help tool known to unload the knee, applied for 3 months on bone marrow lesion size on MRI in people with medial knee OA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50542 0
Prof Kim Bennell
Address 50542 0
Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, Level 7 Alan Gilbert building, 161 Barry St, Carlton VIC 3053
Country 50542 0
Australia
Phone 50542 0
+ 61 3 83444135
Fax 50542 0
Email 50542 0
k.bennell@unimelb.edu.au
Contact person for public queries
Name 50543 0
Dr Ans Van Ginckel
Address 50543 0
Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, Level 7 Alan Gilbert building, 161 Barry St, Carlton VIC 3053
Country 50543 0
Australia
Phone 50543 0
+ 61 3 90353392
Fax 50543 0
Email 50543 0
ans.van@unimelb.edu.au
Contact person for scientific queries
Name 50544 0
Prof Kim Bennell
Address 50544 0
Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, Level 7 Alan Gilbert building, 161 Barry St, Carlton VIC 3053
Country 50544 0
Australia
Phone 50544 0
+ 61 3 83444135
Fax 50544 0
Email 50544 0
k.bennell@unimelb.edu.au