OsteoarthritisFTKOANCT02049216
The Effect of Flexible Tape in Knee Osteoarthritis
A study testing Flexible tape, Fixomull and Exercise in people with Osteoarthritis, run by The Alfred at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Flexible tape, Fixomull and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
- Participants in both groups will have clinically significant improvements in pain and timed performance based measures compared to their baseline scores.
Read the 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
- Conditions
- Osteoarthritis
- Being tested
- Flexible tape, Fixomull, Exercise
- Keywords
- knee, osteoarthritis, tape, exercise, rocktape
- Medical subject headings
- Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible tapeOther
Also called Rocktape
Flexible, elasticised, adhesive athletic tape
FixomullOther
Also called Hypa fix, Medical adhesive tape
ExerciseOther
Also called Strengthening
Participants in both groups will be prescribed a home exercise program to complete.
| Study group | Role | What they receive |
|---|---|---|
| Sham tape | Sham comparator | * 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. Receives: Other: Fixomull; Other: Exercise |
| Flexible tape | Experimental | 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. Receives: Other: Flexible tape; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain on visual analogue scale
- 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)
Measured: baseline, 0,3 and 6 weeks after commencement of intervention
Secondary outcomes (1)
Chang in Knee injury and osteoarthritis outcome score (excluding sport domain)
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.
Measured: baseline, one week, three weeks and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim McManus, The Alfred
- Investigators
- Kim L McManus, B, Physio, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049216
- Sponsor's protocol ID
- FTKOA
- Acronym
- FTKOA
- Status last verified
- Jan 2017
- First submitted
- 22 Jan 2014
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15208174Bennell 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.
PubMed 20851051McManus 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.
PubMed 34555671
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Flexible Tape Versus Placebo Tape in Patients Completing a Home Exercise Program With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02049216
- Acronym / sponsor ID
- FTKOA / FTKOA
- Conditions
- Osteoarthritis
- Keywords
- knee, osteoarthritis, tape, exercise, rocktape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tape | Sham comparator | Other: Fixomull, Other: Exercise* 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. |
| Flexible tape | Experimental | Other: Flexible tape, Other: ExerciseFlexible 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. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible tapeAlso: RocktapeFlexible, elasticised, adhesive athletic tape | Other | Flexible tape |
| FixomullAlso: Hypa fix, Medical adhesive tape | Other | Sham tape |
| ExerciseAlso: StrengtheningParticipants in both groups will be prescribed a home exercise program to complete. | Other | Flexible tape, Sham tape |
Primary outcome
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)
1 secondary outcome
Chang in Knee injury and osteoarthritis outcome score (excluding sport domain)
Time frame: baseline, one week, three weeks and six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Background: PubMed 15208174Tubach 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.
- Background: PubMed 20851051Bennell 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.
- Derived from this study: PubMed 34555671McManus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim L McManus, B, Physio principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible tape, Fixomull and Exercise in people with Osteoarthritis, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain on visual analogue scale (time frame: baseline, 0,3 and 6 weeks after commencement of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02049216, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.