Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000138987
Ethics application status
Approved
Date submitted
7/02/2011
Date registered
7/02/2011
Date last updated
7/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of taping on pain and function in people with knee osteoarthritis.
Scientific title
In persons with moderate to severe knee osteoarthritis, is McConnell patella taping more effective than a placebo in decreasing pain and improving knee kinematics during a step descent task?
Secondary ID [1] 253556 0
nil
Universal Trial Number (UTN)
U1111-1119-1370
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 261116 0
Condition category
Condition code
Musculoskeletal 259263 259263 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly drawn into the taping intervention group and the vitamin E cream placebo group. McConnell taping will be applied to the subject’s knee using three strips of common sports tape, with three corresponding hypoallergenic strips of tape underlying. The patella will be pulled medially, tilted medially and rotated medially. The tape will be applied once to only one knee and for a duration of no more than 10mins in which the participant will step down from a single step for 5 repititions.
Intervention code [1] 257987 0
Treatment: Devices
Comparator / control treatment
Placebo - The vitamin E cream placebo group will have a small amount of cream briefly rubbed into their knee in the area corresponding to where the McConnell taping is applied in the intervention group. The cream will be applied to one knee only and will be briefly rubbed into the skin once immediately before repeating 5 step down repititions off a single step.
Control group
Placebo

Outcomes
Primary outcome [1] 262080 0
Primary Outcome: Difference in knee pain between the patients no taping before intervention pain scores, with the pain scores after the tape/vitamin E cream interventions measured on a visual analogue scale (VAS-10cm).
Timepoint [1] 262080 0
Timepoint: Initial pain at baseline, then tested immediately after each step descent task. A total of five repititions with no tape for each participant, then five more repititions for either tape or cream per participant. Patients can rest for as long as needed between these repititions, but ideally if the patient is able then only 30seconds between repititions.
Secondary outcome [1] 273120 0
Secondary outcome: knee velocity, and knee range of motion of stance limb during the step descent task measured via 3D motion analysis system.
Timepoint [1] 273120 0
Timepoint: Concurrent with performing the task.

Eligibility
Key inclusion criteria
Aged 55-70 years, symptomatic unilateral radiographic grade 2-3 knee OA.
Minimum age
55 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lower limb surgery less than 6 months ago (excluding arthropscopic debridement and partial meniscectomy).
Systemic arthritis.
Symptomatic hip and ankle OA on the ipsilateral side.
Any clinical presentation where participation may be judged to compromise the safety of the research participant.
Known or suspected allergy to tape / elastoplast.
Isolated lateral compartment knee OA.
Diabetics with sensory neuropathy in lower limb.

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)
Participants will be allocated on the day by having them pick a card at random out of a sealed opaque envelopes containing cards written either taping or cream.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
21/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258441 0
Self funded/Unfunded
Name [1] 258441 0
Country [1] 258441 0
Primary sponsor type
Individual
Name
Sareen McLinton currently studying Bachelor of Physiotherapy (Honours) at the University of South Australia
Address
University of South Australia City East campus, North Tce, Adelaide, South Australia 5000
Country
Australia
Secondary sponsor category [1] 257587 0
Individual
Name [1] 257587 0
Dr Dominic Thewlis, Lecturer in Biomechanics at the University of South Australia and Health Science Honours student supervisor.
Address [1] 257587 0
University of South Australia City East campus, North Tce, Adelaide, South Australia 5000
Country [1] 257587 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260429 0
Central Northern Adelaide Health Service Ethics (CNAHS) of Human Research Committee
Ethics committee address [1] 260429 0
Ethics committee country [1] 260429 0
Australia
Date submitted for ethics approval [1] 260429 0
Approval date [1] 260429 0
18/01/2011
Ethics approval number [1] 260429 0
2010162

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32180 0
Address 32180 0
Country 32180 0
Phone 32180 0
Fax 32180 0
Email 32180 0
Contact person for public queries
Name 15427 0
Dr Dominic Thewlis BSc (Hons) PhD (Biomechanics)
Address 15427 0
University of South Australia City Each campus
North Tce Adelaide,
South Australia 5000
Country 15427 0
Australia
Phone 15427 0
+61 8 830 21540
Fax 15427 0
+61 8 830 22766
Email 15427 0
Dominic.Thewlis@unisa.edu.au
Contact person for scientific queries
Name 6355 0
Dr Dominic Thewlis BSc (Hons) PhD (Biomechanics)
Address 6355 0
University of South Australia City Each campus
North Tce Adelaide,
South Australia 5000
Country 6355 0
Australia
Phone 6355 0
+61 8 830 21540
Fax 6355 0
+61 8 830 22766
Email 6355 0
Dominic.Thewlis@unisa.edu.au

No information has been provided regarding IPD availability


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.