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Patellofemoral Pain SyndromeNCT05629286

Rigid Taping and Patella Stabilizing Brace Methods in pwPFPS (Patient With Patellofemoral Pain Syndrome)

An observational study of Patellofemoral Pain Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Patellofemoral Pain Syndrome
What is being tested?
McConnell taping and Patella Stabilizer Brace
Type of treatment
Medical device
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2023to 22 Dec 2024
How long will I take part?
3 Weeks
Phase
Observational
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • The presence of neurological problems that will affect balance and walking
  • Having any rheumatological disease
  • The use of an assistive device for the ambulance

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpaşa

    Istanbul, 34500

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

Voluntary participants who have been diagnosed with PFPS and agreed to voluntary health subjects will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into tree groups. One of the intervention groups will be taped first, then brace; the other will be used brace first, then tape. Healthy individuals will form the control group.

Being tested
McConnell taping, Patella Stabilizer Brace
Keywords
McConnell Taping, Patella Stabilazing Brace, Proprioception, Balance, Gait, Functionality
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • McConnell tapingDevice

    non-stretch rigid McConnell tape will be applied

  • Patella Stabilizer BraceDevice

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

Study groups in NCT05629286
Study groupRoleWhat they receive
Intervention Group 1McConnell taping first and then patella stabilizing brace applied to healty participants and patients with PFPS
Receives: Device: McConnell taping; Device: Patella Stabilizer Brace
Intervention Group 2first patella stabilizing brace and then applied McConnell taping to healty participants and patients with PFPS
Receives: Device: McConnell taping; Device: Patella Stabilizer Brace
No Intervention Groupno intervention to healty participants and patients with PFPS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kujala Patellofemoral Scoring

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

    Measured: up to three weeks

  2. 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.

    Measured: up to three weeks

Secondary outcomes (5)
  1. 10 Stair Up Test

    Participants will go up and down with both feet 10 times on a hard step 20 centimeters above the ground.

    Measured: up to three weeks

  2. Squat

    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.

    Measured: up to three weeks

  3. Joint Position Sense

    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.

    Measured: up to three weeks

  4. Single Leg Stance Test

    Evaluates the standing balance of the participants.

    Measured: up to three weeks

  5. Y Balance Test

    The Y balance test is a dynamic test performed in a one-legged posture that requires strength, flexibility, core control and proprioception.

    Measured: up to three weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2022
  2. Study start1 Feb 2023
  3. Primary completion18 Sep 2024
  4. Study completion22 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
36 participants (actual)
Target duration
3 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT05629286
Sponsor's protocol ID
A-9230347
Status last verified
Dec 2024
First submitted
10 Nov 2022
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32987346
  • 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.

    PubMed 29392329
  • 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.

    PubMed 29925502
  • 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.

    PubMed 25603546
  • 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.

    PubMed 27512259
  • 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.

    PubMed 32500350
  • 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.

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

    PubMed 11386839
  • 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.

    PubMed 35484009
  • 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.

    PubMed 20676018
  • 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.

    PubMed 12076444
  • 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.

    PubMed 15129407
  • 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.

    PubMed 22944525
  • 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.

    PubMed 24183777

Questions about this trial

What is this clinical trial studying?

An observational study of Patellofemoral Pain Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

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 9 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 27 Dec 2024. 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 Turkey (Türkiye). 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. 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?

Kujala Patellofemoral Scoring (time frame: up to three weeks). The study lists 2 primary outcomes in all. 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 NCT05629286, which also lists 14 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 27 Dec 2024.

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