- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05629286
Rigid Taping and Patella Stabilizing Brace Methods in pwPFPS (Patient With Patellofemoral Pain Syndrome)
Immediate Effect of Rigid Taping and Patella Stabilizing Brace on Proprioception, Functionality, and Balance in Patients With Patellofemoral Pain Syndrome
Patellofemoral pain syndrome (PFPS) is a common musculoskeletal disease with an annual prevalence of 22.7%. Pain in the anterior of the knee and/or retropatellar and/or peripatellar region patellofemoral compression force increases, squatting, climbing stairs, prolonged sitting is characterized by increased pain related activities such as flexion after.
A large number of different treatment strategies have been proposed to examine these underlying factors and to address the resulting disorders and activity limitations. PFPS in the conservative treatment of patellar taping, stretching the shortened structures, the vastus medialis obliquus, strengthening activity modification, biofeedback, neuromuscular electrical stimulation, ultrasound, and foot orthoses and brace is located. The most frequently used for the treatment of patients with high effect size physiotherapy treatment and exercise training combined treatment in order to control the pain in the short and medium term, while the external knee supports-foot orthoses (brace), kinesiotape, rigid-band is used. It is known that the most commonly recommended external support for patients in the fight against PFPS in the clinical setting is kinesiological taping and brace. However, since kinesiotaping does not show orthotic properties like brace, their comparison with each other and the study of their effects give misleading results. The use of McConnell taping, which can show similar effects with both kinesiotaping and brace, gives clinically positive results. When the literature was examined, there was no study that examined the effectiveness of brace and rigid taping comparatively. In our study, we aim to investigate the extent to which we can change the impaired patella position in PFPS with the use of rigid tape and brace in accordance with this information in the literature and to examine the possible effects of rigid tape and brace, which we will apply to patients with PFPS, on balance, proprioception, gait and functionality in patients. In line with the results we will obtain, it is aimed to increase the effectiveness of treatment and shorten the recovery time by determining the external support that will help patients exercise and their movements in daily life.
H1: McConnell taping and patella stabilizing brace applications applied to patients with PFPS differ from each other in terms of proprioception, functionality, balance and gait parameters.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34500
- Istanbul University-Cerrahpasa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- being 18-50 years old
- Having been diagnosed with patellofemoral pain syndrome
- BMI <30 kg/m2
- For the last 3 months, the pain in the front of the knee in descending stairs, squatting and functional activities has been > 3 points on the visual analog scale
Exclusion Criteria:
- The presence of an organic lesion (chondromalesia patella, syndrome of excessive lateral pressure, peripatellar bursitis, bening-malignant neoplasm, tendonitis) that can cause pain in the front of the knee
- Having had steroid injections in the knee within the last 6 months and/or having received a physiotherapy program for the knee
- Having undergone lower extremity surgery
- Having a diagnosis of Grade 2 and above osteoarthritis according to Kellgren Lawrence
- Presence of Patellar Tendinopathy
- Presence of a history of trauma to the lower extremities
- The presence of neurological problems that will affect balance and walking
- Having any rheumatological disease
- The use of an assistive device for the ambulance
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Intervention Group 1
McConnell taping first and then patella stabilizing brace applied to healty participants and patients with PFPS
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non-stretch rigid McConnell tape will be applied
An orthotic application that wraps the patellofemoral joint, which has a patellar cavity and supports the patella, and provides stabilization with velcro
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Intervention Group 2
first patella stabilizing brace and then applied McConnell taping to healty participants and patients with PFPS
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non-stretch rigid McConnell tape will be applied
An orthotic application that wraps the patellofemoral joint, which has a patellar cavity and supports the patella, and provides stabilization with velcro
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No Intervention Group
no intervention to healty participants and patients with PFPS
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Kujala Patellofemoral Scoring
Time Frame: up to three weeks
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It is a tool that allows functional evaluation in knee complaints due to patellofemoral structure.
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up to three weeks
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Visual Analog Scale
Time Frame: up to three weeks
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The maximum pain intensity assessment of the participants during walking, climbing stairs, descending stairs, sitting and squatting activities will be performed using a 10 cm VAS.
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up to three weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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10 Stair Up Test
Time Frame: up to three weeks
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Participants will go up and down with both feet 10 times on a hard step 20 centimeters above the ground.
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up to three weeks
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Squat
Time Frame: up to three weeks
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Participants will be asked to squat from their knees to the point where they cannot see their toes.
It will be recorded how many seconds the participants did the 5 repetitions.
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up to three weeks
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Joint Position Sense
Time Frame: up to three weeks
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To assess the knee proprioception of the participants, the method of active presence of a passively determined position will be applied.
The patient's extremity is brought to a position and she is expected to bring it to the same position.
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up to three weeks
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Single Leg Stance Test
Time Frame: up to three weeks
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Evaluates the standing balance of the participants.
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up to three weeks
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Y Balance Test
Time Frame: up to three weeks
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The Y balance test is a dynamic test performed in a one-legged posture that requires strength, flexibility, core control and proprioception.
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up to three weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yildiz Analay Akbaba, Assoc. Prof., Istanbul University - Cerrahpasa
Publications and helpful links
General Publications
- Kurt EE, Buyukturan O, Erdem HR, Tuncay F, Sezgin H. Short-term effects of kinesio tape on joint position sense, isokinetic measurements, and clinical parameters in patellofemoral pain syndrome. J Phys Ther Sci. 2016 Jul;28(7):2034-40. doi: 10.1589/jpts.28.2034. Epub 2016 Jul 29.
- Collins NJ, Barton CJ, van Middelkoop M, Callaghan MJ, Rathleff MS, Vicenzino BT, Davis IS, Powers CM, Macri EM, Hart HF, de Oliveira Silva D, Crossley KM. 2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017. Br J Sports Med. 2018 Sep;52(18):1170-1178. doi: 10.1136/bjsports-2018-099397. Epub 2018 Jun 20.
- Dobson F, Hinman RS, Hall M, Terwee CB, Roos EM, Bennell KL. Measurement properties of performance-based measures to assess physical function in hip and knee osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2012 Dec;20(12):1548-62. doi: 10.1016/j.joca.2012.08.015. Epub 2012 Aug 31.
- Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.
- Clifford AM, Dillon S, Hartigan K, O'Leary H, Constantinou M. The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome. Gait Posture. 2020 Oct;82:266-272. doi: 10.1016/j.gaitpost.2020.09.010. Epub 2020 Sep 15.
- Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.
- Sisk D, Fredericson M. Taping, Bracing, and Injection Treatment for Patellofemoral Pain and Patellar Tendinopathy. Curr Rev Musculoskelet Med. 2020 Aug;13(4):537-544. doi: 10.1007/s12178-020-09646-8.
- Barton CJ, Lack S, Hemmings S, Tufail S, Morrissey D. The 'Best Practice Guide to Conservative Management of Patellofemoral Pain': incorporating level 1 evidence with expert clinical reasoning. Br J Sports Med. 2015 Jul;49(14):923-34. doi: 10.1136/bjsports-2014-093637. Epub 2015 Feb 25.
- McConnell J. Management of patellofemoral problems. Man Ther. 1996 Mar;1(2):60-6. doi: 10.1054/math.1996.0251.
- Deng F, Adams R, Pranata A, Cui F, Han J. Tibial internal and external rotation taping for improving pain in patients with patellofemoral pain syndrome. J Sci Med Sport. 2022 Aug;25(8):644-648. doi: 10.1016/j.jsams.2022.04.003. Epub 2022 Apr 12.
- Kuru T, Dereli EE, Yaliman A. Validity of the Turkish version of the Kujala patellofemoral score in patellofemoral pain syndrome. Acta Orthop Traumatol Turc. 2010;44(2):152-6. doi: 10.3944/AOTT.2010.2252.
- D'hondt NE, Struijs PA, Kerkhoffs GM, Verheul C, Lysens R, Aufdemkampe G, Van Dijk CN. Orthotic devices for treating patellofemoral pain syndrome. Cochrane Database Syst Rev. 2002;(2):CD002267. doi: 10.1002/14651858.CD002267.
- Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004 May;85(5):815-22. doi: 10.1016/s0003-9993(03)00613-0.
- van der Heijden RA, Lankhorst NE, van Linschoten R, Bierma-Zeinstra SM, van Middelkoop M. Exercise for treating patellofemoral pain syndrome. Cochrane Database Syst Rev. 2015 Jan 20;1(1):CD010387. doi: 10.1002/14651858.CD010387.pub2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-9230347
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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