The Effect of Flexible Tape in Knee Osteoarthritis (FTKOA)

January 24, 2017 updated by: Kim McManus, The Alfred

The Effect of Flexible Tape Versus Placebo Tape in Patients Completing a Home Exercise Program With Knee Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Interventions:

Participants in both groups will attend physiotherapy on 4 occasions, in addition to an initial appointment where baseline data will be collected.

All participants will be provided with an individualised home exercise program. This will be provided based on the investigators' clinical experience and evidence based programs. The participant will be provided with a handout detailing the exercises they are to complete, including dosage. If there is excessive pain or difficulty associated with completing an exercise the participant will be advised to cease that particular exercise until they have been reviewed by the researcher the following week.

Participants will have their knee taped according to either the therapeutic flexible taping protocol, or the placebo taping protocol depending on which group they have been randomly allocated to on three occasions at one week intervals. All participants will be provided with written information regarding tape allergies and when to remove the tape from their knee. To control for the Hawthorne effect participants will not be aware of whether they are in the intervention or placebo group.

Participants will attend for appointments once per week for three weeks. They will then have a three week period of no intervention and return for a review and completion of the study. At this time the participant can be referred for further physiotherapy intervention as is clinically indicated. This may include physiotherapy at The Alfred Hospital, private practice or the participants' local health services.

If at anytime a participant wishes to withdraw from the study they can be referred by the investigators to continue their physiotherapy in the appropriate setting.

Sample size calculations: The investigators hypothesise that the combination of taping and an exercise program will give rise to clinically significant improvements in functional capacity, symptoms and quality of life. If there is truly no difference in the change in VAS between placebo and therapeutic based groups, then 30 patients are required to be 90% sure that the 95% confidence interval will exclude a difference in means of more than 20mm. This has been demonstrated by Tubach and colleagues in 2005. This assumes a standard deviation of the change in VAS of 21.5. Due to participant attrition anticipated an additional 20% will be recruited to the sample. This will total 36 participants in total.

Feasibility: The osteoarthritis hip and knee clinic at The Alfred hospital review approximately 13 patients per week of which the majority would be appropriate for inclusion in this trial. There are also many referrals from orthopaedics, rheumatology and emergency for patients who will be appropriate for inclusion. It is therefore anticipated that recruitment to the study will not be a barrier to completion of this trial.

Statistical analysis: All data will be analysed by intention to treat. Continuous variables will be analysed using analysis of covariance, controlling for baseline values and recruitment centre. The proportion of participants who complete the program will be compared between groups using a chi-squared test and the relative risk of non-completion will be determined. Alpha will be set at 0.05

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Prahran, Victoria, Australia, 3141
        • The Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Fixomull
Other Names:
  • Hypa fix
  • Medical adhesive tape
Other: Exercise
Participants in both groups will be prescribed a home exercise program to complete.
Other Names:
  • Strengthening
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: Exercise
Participants in both groups will be prescribed a home exercise program to complete.
Other Names:
  • Strengthening
Other: Flexible tape
Flexible, elasticised, adhesive athletic tape
Other Names:
  • Rocktape

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain on visual analogue scale
Time Frame: baseline, 0,3 and 6 weeks after commencement of intervention
• Pain on a Visual Analogue Scale (VAS) over last 48hrs at rest and movement. Anchors used will be no pain and worst imaginable pain. The VAS has been found to be valid, reliable and sensitive to change in this population (Tubach et al, 2005)
baseline, 0,3 and 6 weeks after commencement of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chang in Knee injury and osteoarthritis outcome score (excluding sport domain)
Time Frame: baseline, one week, three weeks and six weeks
The KOOS, a valid and reliable functional questionnaire in patients with knee conditions covering the domains of function, symptoms, quality of life and sport . Sport will not be included in analysis as this is not relevant to the study population.
baseline, one week, three weeks and six weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 30 sec STS test
Time Frame: baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks

The maximum number of chair stand repetitions possible in a 30 second period as per protocol available at:

http://www.oarsi.org/sites/default/files/docs/2013/manual.pdf
baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks
Change in time taken to climb 3 steps
Time Frame: baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks

The time (in seconds) it takes to ascend and descend a 3 stairs as per protocol available at:

http://www.oarsi.org/sites/default/files/docs/2013/manual.pdf
baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks
Change in time to complete 40m walk test
Time Frame: baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks

A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft) as per protocol available at:

http://www.oarsi.org/sites/default/files/docs/2013/manual.pdf
baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks
Change in pain on visual analogue scale (VAS) during 30 sec sit to stand test
Time Frame: prior to initial knee taping and 30mins later following knee tape
Once 30sec sit to stand is completed participants to rate pain on VAS
prior to initial knee taping and 30mins later following knee tape
Change in pain on visual analogue scale (VAS) 40m walk test
Time Frame: prior to initial knee taping and 30mins later following knee tape
Once 40m walk test is completed participants to rate pain on VAS
prior to initial knee taping and 30mins later following knee tape
Change in pain on visual analogue scale (VAS) 3 stair climb test
Time Frame: prior to initial knee taping and 30mins later following knee tape
Once 3 stair climb test is completed participants to rate pain on VAS
prior to initial knee taping and 30mins later following knee tape
Change in amount of weekly analgesia medication consumed
Time Frame: weekly for 4 weeks
Participants will be asked to keep a record of the number of tablets they take per week for pain relief. This will be compared within each particiapnt over the first four weeks of the study period.
weekly for 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Alfred

Investigators

  • Principal Investigator: Kim L McManus, B, Physio, The Alfred

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (ESTIMATE)

January 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FTKOA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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