Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001259730
Ethics application status
Approved
Date submitted
14/11/2013
Date registered
18/11/2013
Date last updated
18/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of self knee taping versus therapist knee taping in people with patellofemoral osteoarthritis
Scientific title
The effect of self taping on pain and function in people with mild to moderate radiographic severity patellofemoral knee osteoarthritis
Secondary ID [1] 283591 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
SKTPO: Self knee taping for Patellofemoral Osteoarthritis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Isolated Patellofemoral osteoarthritis or co-existed with tibiofemoral osteoarthritis. 290511 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290898 290898 0 0
Physiotherapy
Musculoskeletal 290918 290918 0 0
Osteoarthritis
Alternative and Complementary Medicine 290919 290919 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Commercially hypoallergenic knee tape (Hypafix) will be tested. The knee tape will be used to induce medial gliding of knee patella. Tape will be applied by physiotherapist 1 in Arm 1. In Arm 2, Tape will be applied by patient after getting detailed instructions from physiotherapist 2. In order to improve adherence from patients in arm 2, Patients will be required to report date and time of taping sessions, and return of unused tape. Patients in both groups will be contacted every 3-4 days to confirm appointment date (arm 1) or ensure ability to apply self taping. An independent investigator (observer 1) will open the sealed opaque envelope indicating whether patient will be allocated in arm 1 or arm 2. In addition, he will collect questionnaires after final treatment from observer 2.
The outcome investigator (observer 2) will remain blinded to test condition (therapist taping vs. Self taping) for the study duration. He will be responsible for distribution and collecting questionnaires at baseline and post-treatment and send them to observer 1.

Arm 1: Therapeutic tape will be applied by Physiotherapist 1

Arm 2: Therapeutic tape will be applied by patient himself with supervision by physiotherapist 2.

Exposure: The tape will be applied for 6 weeks starting from first treatment session. Tape will be replaced every 3-4 days at clinic for arm 1. Subjects in arm 2 will be supplied with pre-cut tape to apply at home with detailed instructions.



Intervention code [1] 288278 0
Rehabilitation
Intervention code [2] 288294 0
Treatment: Other
Comparator / control treatment
The effects of the self knee tape (treatment group) on pain and function will be compared with therapist-applied knee taping (comparator group) at baseline and after 6 weeks of continuous treatment.
Control group
Active

Outcomes
Primary outcome [1] 290882 0
Primary outcome: Visual Analogue Score (VAS) of knee pain.
Timepoint [1] 290882 0
VAS
Time point: 0 minutes (baseline), 6 weeks post-treatment for arm1 and arm2 groups.
Primary outcome [2] 290883 0
Pain, function and symptom sub-scores of Knee objective outcome score (KOOS) will be collected.
Timepoint [2] 290883 0
KOOS
Time point: 0 minutes (baseline), 6 weeks post-treatment for arm1 and arm2 groups.
Secondary outcome [1] 305536 0
Nil.
Timepoint [1] 305536 0
Nil.

Eligibility
Key inclusion criteria
i) Confirmed diagnosis of Mild to moderate of isolated Patellofemroal or co-existed with tibiofemoral knee osteoarthritis; ii) aged at least 35 years at the time of treatment; iii) pain during aggravating activities present on most days during the past month; and v) radiographic OA severity of greater than or equal to 2 on Kellgren and Lawrence grading (Kellgren, 1957).
Minimum age
35 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
i) concomitant pain from hip or lumbar spine; ii) recent knee injections (3 months); iii) planned lower limb surgery in the following 6 months; iv) knee or hip arthroplasty or osteotomy; v) Any history of skin problems prevent application of patellar taping; vii) inability to understand written and spoken Arabic/English.

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)
Following provision of informed consent, Patients at first treatment session will be allocated randomly by sealed opaque envelopes to either arm 1 or arm 2 groups. This concealed allocation will be performed by independent investigator (from outside of physiotherapy clinic). The assessor will remain blinded group allocation until all analyses have been finalized.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer generated randomization
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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/08/2013
Actual
12/09/2013
Date of last participant enrolment
Anticipated
30/01/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5623 0
Saudi Arabia
State/province [1] 5623 0
Eastern Province

Funding & Sponsors
Funding source category [1] 288269 0
Hospital
Name [1] 288269 0
King Khaled General Hospital
Hafr Albatin
Country [1] 288269 0
Saudi Arabia
Primary sponsor type
Hospital
Name
King Khaled General Hospital
Address
King Khaled General Hospital
Hafr Albatin 31991
Eastern Province
Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 287003 0
None
Name [1] 287003 0
Nil.
Address [1] 287003 0
Nil.
Country [1] 287003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290166 0
Ethical Comittee at KKGH.
Ethics committee address [1] 290166 0
King Khaled Geneal Hospital,
Hafr Albatin, 31991
Eastern Province
Saudi Arabia
Ethics committee country [1] 290166 0
Saudi Arabia
Date submitted for ethics approval [1] 290166 0
Approval date [1] 290166 0
23/05/2013
Ethics approval number [1] 290166 0

Summary
Brief summary
Osteoarthritis (OA) is a global problem, commonly developed in the knee joint. The prevalence of radiographic tibiofemoral osteoarthritis (TFOA) in elderly American subjects is about 44% in those 80 years or older, whereas it is only 27% in those younger than 80 with a slight higher percentage in women than men . The prevalence of patellofemroal osteoarthritis (PFOA) is approximately at same percentage, in patients with degenerative changes of the knee; about half has arthritis in patellofemoral joints. McAlindon, Snow et al. (1992) was among the firsts who investigated the prevalence of PFOA in UK and worldwide; authors reported that 19% of men and 34% of women over the age of 55 have radiographic degenerative changes isolated to the patellofemoral joint in a community based British study. Davies, Vince et al. (2002).

Therapeutic taping (clinical-based) has been used extensively in physiotherapy practice. However, with no availability of cure and progressive nature of patellofemroal osteoarthritis, there is urgent need to test whether simpler and easier to apply taping technique are effective or not. Self taping is a cost-effective and easier to apply technique comparing to clinical-based patellar taping.

This clinical trial aims to explore whether this technique (self patellar taping ) able to produce similar effects compared with commonly used therapeutic taping or not.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44310 0
Mr Ameer Almubarak
Address 44310 0
Department of Physiotherapy, King Khaled General Hospital, Hafr Albatin 31991, Eastern Provice
Country 44310 0
Saudi Arabia
Phone 44310 0
+966558877635
Fax 44310 0
Email 44310 0
aaalmubarak@moh.gov.sa
Contact person for public queries
Name 44311 0
Mr Ameer Almubarak
Address 44311 0
Department of Physiotherapy, King Khaled General Hospital, Hafr Albatin 31991, Eastern Provice
Country 44311 0
Saudi Arabia
Phone 44311 0
+966558877635
Fax 44311 0
Email 44311 0
aaalmubarak@moh.gov.sa
Contact person for scientific queries
Name 44312 0
Mr Ameer Almubarak
Address 44312 0
Department of Physiotehrapy, King KHaled General Hospital, Hafr Albatin 31991
Country 44312 0
Saudi Arabia
Phone 44312 0
+966558877635
Fax 44312 0
Email 44312 0
aaalmubarak@moh.gov.sa

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

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