NCT05629286

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

November 10, 2022

Last Update Submit

December 22, 2024

Conditions

Keywords

McConnell TapingPatella Stabilazing BraceProprioceptionBalanceGaitFunctionality

Outcome Measures

Primary Outcomes (2)

  • Kujala Patellofemoral Scoring

    It is a tool that allows functional evaluation in knee complaints due to patellofemoral structure.

    up to three weeks

  • Visual Analog Scale

    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.

    up to three weeks

Secondary Outcomes (5)

  • 10 Stair Up Test

    up to three weeks

  • Squat

    up to three weeks

  • Joint Position Sense

    up to three weeks

  • Single Leg Stance Test

    up to three weeks

  • Y Balance Test

    up to three weeks

Study Arms (3)

Intervention Group 1

McConnell taping first and then patella stabilizing brace applied to healty participants and patients with PFPS

Device: McConnell tapingDevice: Patella Stabilizer Brace

Intervention Group 2

first patella stabilizing brace and then applied McConnell taping to healty participants and patients with PFPS

Device: McConnell tapingDevice: Patella Stabilizer Brace

No Intervention Group

no intervention to healty participants and patients with PFPS

Interventions

non-stretch rigid McConnell tape will be applied

Intervention Group 1Intervention Group 2

An orthotic application that wraps the patellofemoral joint, which has a patellar cavity and supports the patella, and provides stabilization with velcro

Intervention Group 1Intervention Group 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who have been diagnosed with PFPS, healthy people for control group

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

    PMID: 32987346BACKGROUND
  • 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.

    PMID: 29392329BACKGROUND
  • 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.

    PMID: 29925502BACKGROUND
  • 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.

    PMID: 25603546BACKGROUND
  • 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.

    PMID: 27512259BACKGROUND
  • 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.

    PMID: 32500350BACKGROUND
  • 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.

    PMID: 25716151BACKGROUND
  • McConnell J. Management of patellofemoral problems. Man Ther. 1996 Mar;1(2):60-6. doi: 10.1054/math.1996.0251.

    PMID: 11386839BACKGROUND
  • 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.

    PMID: 35484009BACKGROUND
  • 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.

    PMID: 20676018BACKGROUND
  • 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.

    PMID: 12076444BACKGROUND
  • 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.

    PMID: 15129407BACKGROUND
  • 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.

    PMID: 22944525BACKGROUND
  • 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.

    PMID: 24183777BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Yildiz Analay Akbaba, Assoc. Prof.

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2022

First Posted

November 29, 2022

Study Start

February 1, 2023

Primary Completion

September 18, 2024

Study Completion

December 22, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations