Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000644268
Ethics application status
Approved
Date submitted
4/06/2009
Date registered
30/07/2009
Date last updated
30/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of patellar tape on patellar malalignment and pain in people with patellofemoral osteoarthritis
Scientific title
The effect of patellar tape on patellar malalignment and pain 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 236914 0
Condition category
Condition code
Musculoskeletal 237271 237271 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 237272 237272 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) application of tape
Taping to correct patellar alignment was applied in a standardized manner by the same investigator who is an experienced physiotherapist. Where necessary, skin was shaved prior to tape application. Two pieces of rigid tape (Leuko Sportstape Premium Plus, Beiersdorf Australia Ltd) were used to apply a medial patellar glide, as well as a medial and superior tilt to the patellar. To unload the infrapatellar fat pad, another two pieces of tape were applied distal to the patella. Hypoallergenic tape (Fixomull (registered trademark) stretch, Beiersdorf Australia Ltd) was applied beneath the rigid tape to prevent skin irritation. Participants were asked to report any symptoms of skin irritation while they wore the tape, and the knee was inspected after the tape was removed.
b) tape was applied immediately prior to testing and worn only for the duration of testing (ie 30 - 60 minutes)
c) duration between intervention and control was 30 - 60 minutes
Intervention code [1] 236972 0
Rehabilitation
Comparator / control treatment
The comparator treatment was no tape. The duration between the two interventions was 30-60 minutes. Therefore, if a person was randomised to receive tape first, there was a 30-60 minute break between removal of tape and the control (no tape) testing; if a person was randomsied to the control condition (no tape) first, this was followed by a break of 30-60 iminutes before the tape was applied
Control group
Active

Outcomes
Primary outcome [1] 238084 0
patellar alignment, measured from axial scans of magnetic resonance imaging
Timepoint [1] 238084 0
immediately after application of tape and no tape
Secondary outcome [1] 242283 0
pain during squatting, measured on a 100mm visual analogue scale
Timepoint [1] 242283 0
immediately after application of tape and no tape

Eligibility
Key inclusion criteria
inclusion was based on: (i) history of knee pain in the preceding week on at least two of the following activities: stair ambulation, squatting, rising from sitting and locomotion (walking and/or jogging); (ii) average overall knee pain >3 points on a 10 point numerical pain scale; (iii) primary area of pain described in the anterior or retropatellar regions; (iv) physical examination revealing tenderness in the peri-patellar region; and (v) radiographic evidence of either an osteophyte of severity at least grade 2, or joint space narrowing of at least grade 1 with concurrent grade 1 osteophyte(s) in the patellofemoral joint (PFJ) on skyline x-ray. Individuals with concomitant tibiofemoral joint (TFJ) osteoarthritis (OA) were included if the predominant source of symptoms was deemed to be from the PFJ.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) pain at a site distant to the patellar; (ii) concomitant injury or pathology in the lumbar spine, hip or other knee joint structures; (iii) history of fracture, arthroplasty or osteotomy of the knee or hip; (iv) inability to understand written and spoken English; (v) history of allergic reaction to tape; or (vi) contraindications for magnetic resonance (MR) imaging (eg implanted metal in vital organs).

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)
After consent, the investigator opened the envelope that indicated the order of the taping condition (tape, no tape).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sinple randomisation, computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237105 0
Charities/Societies/Foundations
Name [1] 237105 0
ANZ Charitable Funds
Country [1] 237105 0
Australia
Primary sponsor type
University
Name
Early Career Research Scheme
Address
The University of Melbourne
Parkville, Victoria 3010
Country
Australia
Secondary sponsor category [1] 4606 0
None
Name [1] 4606 0
Address [1] 4606 0
Country [1] 4606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239200 0
Human Research Ethics Committee
Ethics committee address [1] 239200 0
Ethics committee country [1] 239200 0
Australia
Date submitted for ethics approval [1] 239200 0
Approval date [1] 239200 0
17/07/2006
Ethics approval number [1] 239200 0
0714623.1

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

Contacts
Principal investigator
Name 29692 0
Address 29692 0
Country 29692 0
Phone 29692 0
Fax 29692 0
Email 29692 0
Contact person for public queries
Name 12939 0
Kay Crossley
Address 12939 0
Melbourne School of Engineering
Department of Mechanical Engineering
The University of Melbourne
Victoria
3010
Country 12939 0
Australia
Phone 12939 0
+61 383448646
Fax 12939 0
Email 12939 0
[email protected]
Contact person for scientific queries
Name 3867 0
Kay Crossley
Address 3867 0
Melbourne School of Engineering
Department of Mechanical Engineering
The University of Melbourne
Victoria, 3010
Country 3867 0
Australia
Phone 3867 0
+61 383448646
Fax 3867 0
Email 3867 0
[email protected]

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.