The Effect of Flexible Tape in Knee Osteoarthritis

NCT02049216 | Completed

• 1 other identifier: FTKOA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 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. 2.Participants in both groups will have clinically significant improvements in pain and timed performance based measures compared to their baseline scores.

Conditions

Osteoarthritis

Keywords

knee; osteoarthritis; tape; exercise; rocktape

Outcome Measures

Primary Outcomes (1)

• 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)

  baseline, 0,3 and 6 weeks after commencement of intervention

Secondary Outcomes (1)

• Chang in Knee injury and osteoarthritis outcome score (excluding sport domain)

  baseline, one week, three weeks and six weeks

Other Outcomes (7)

• Change in 30 sec STS test

  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

  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

  baseline, 1 week from baseline with no intervention (control period), immediately after the first tape application (one week), three weeks and six weeks

Study Arms (2)

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.

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.

Other: Flexible tape; Other: Exercise

Interventions

Flexible tape OTHER

Flexible, elasticised, adhesive athletic tape

Also known as: Rocktape

Flexible tape

Fixomull OTHER

Also known as: Hypa fix, Medical adhesive tape

Sham tape

Exercise OTHER

Participants in both groups will be prescribed a home exercise program to complete.

Also known as: Strengthening

Flexible tape; Sham tape

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead

Study Sites (1)

The Alfred Hospital

Prahran, Victoria, 3141, Australia

Location

Related Publications (3)

• 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.

  PMID: 15208174 BACKGROUND

• 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.

  PMID: 20851051 BACKGROUND

• 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.

  PMID: 34555671 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Kim L McManus, B, Physio

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 30, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

AU (1)