Clinical trial NCT02049216: The Effect of Flexible Tape in Knee Osteoarthritis
Official title: The Effect of Flexible Tape Versus Placebo Tape in Patients Completing a Home Exercise Program With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: knee
osteoarthritis
tape
exercise
rocktape
Lead sponsor: The Alfred
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain on visual analogue scale
timeFrame: baseline, 0,3 and 6 weeks after commencement of intervention
Secondary outcomes:
measure: Chang in Knee injury and osteoarthritis outcome score (excluding sport domain)
timeFrame: baseline, one week, three weeks and six weeks
Other outcomes:
measure: Change in 30 sec STS test
timeFrame: baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks
measure: Change in time taken to climb 3 steps
timeFrame: baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks
measure: Change in time to complete 40m walk test
timeFrame: baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks
measure: Change in pain on visual analogue scale (VAS) during 30 sec sit to stand test
timeFrame: prior to initial knee taping and 30mins later following knee tape
measure: Change in pain on visual analogue scale (VAS) 40m walk test
timeFrame: prior to initial knee taping and 30mins later following knee tape
measure: Change in pain on visual analogue scale (VAS) 3 stair climb test
timeFrame: prior to initial knee taping and 30mins later following knee tape
measure: Change in amount of weekly analgesia medication consumed
timeFrame: weekly for 4 weeks
Locations:
city: Prahran
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: Kim L McManus, B, Physio
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: McManus KL, Kimmel LA, Holland AE. Rocktape provides no benefit over sham taping in people with knee osteoarthritis who are completing an exercise program: a randomised trial. Physiotherapy. 2021 Dec;113:29-36. doi: 10.1016/j.physio.2021.05.005. Epub 2021 May 17.