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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02049216




Registration number
NCT02049216
Ethics application status
Date submitted
22/01/2014
Date registered
30/01/2014
Date last updated
26/01/2017

Titles & IDs
Public title
The Effect of Flexible Tape in Knee Osteoarthritis
Scientific title
The Effect of Flexible Tape Versus Placebo Tape in Patients Completing a Home Exercise Program With Knee Osteoarthritis
Secondary ID [1] 0 0
FTKOA
Universal Trial Number (UTN)
Trial acronym
FTKOA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Flexible tape
Other interventions - Fixomull
Other interventions - Exercise

Sham Comparator: Sham tape - Fixomull tape only
Single piece of 10cm wide, 32cm long applied from inferior to tibial tuberosity, over patella and onto quadriceps muscle. Corners rounded. Tape to be applied with the knee in 90 degrees flexion.
Participants in both groups will also be prescribed an individualised home exercise program by a physiotherapist.

Experimental: Flexible tape - Flexible tape (rocktape brand) applied as follows:
First piece of tape 10 cm wide and 32cm long (length of a standard goniometer). Split down centre 18cm from 1 end. Second piece of tape 5cm wide and 14cm long.
Tape applied in 90 degrees knee flexion Applied with no tension in proximal and distal ends. 30% tension to un-split portion placed over quads. 50% tension to split portion placed either side of patella and crossing over at tibial tuberosity Additional piece of 5cm wide flexible tape applied with 80% tension over patella tendon, with no tension in 3cm from ends All tape corners rounded
Participants in both groups will also be prescribed an individualised home exercise program by a physiotherapist.


Other interventions: Flexible tape
Flexible, elasticised, adhesive athletic tape

Other interventions: Fixomull


Other interventions: Exercise
Participants in both groups will be prescribed a home exercise program to complete.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in pain on visual analogue scale
Timepoint [1] 0 0
baseline, 0,3 and 6 weeks after commencement of intervention
Secondary outcome [1] 0 0
Chang in Knee injury and osteoarthritis outcome score (excluding sport domain)
Timepoint [1] 0 0
baseline, one week, three weeks and six weeks

Eligibility
Key inclusion criteria
- clinical diagnosis of osteoarthritis of the knee

- radiological diagnosis of osteoarthritis of the knee

- able to understand basic English

- knee outcome and injury scale available in patients's preferred language
Minimum age
40 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- other significant lower limb pathology

- previous total knee replacement in effected knee

- co-morbidities limiting participation in a basic home exercise program or performance
of outcome measures eg. unstable cardiac or respiratory conditions

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
3141 - Prahran

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
People with osteoarthritis (OA) of the knee attending The Alfred hospital will be invited to
participate in a randomised controlled trial comparing two different types of knee taping.
Both groups will also be prescribed an exercise program to assist in management of their knee
OA.

Hypothesis are as follows:

1. Participants treated with flexible tape with have greater reductions in pain and
improvements on timed performance based measures when compared to those treated with a
placebo tape.

2. Participants in both groups will have clinically significant improvements in pain and
timed performance based measures compared to their baseline scores.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02049216
Trial related presentations / publications
Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.
Bennell KL, Hinman RS. A review of the clinical evidence for exercise in osteoarthritis of the hip and knee. J Sci Med Sport. 2011 Jan;14(1):4-9. doi: 10.1016/j.jsams.2010.08.002. Epub 2010 Sep 17.
Public notes

Contacts
Principal investigator
Name 0 0
Kim L McManus, B, Physio
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02049216