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

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Immediate Effect of Rigid Taping and Patella Stabilizing Brace on Proprioception, Functionality, Gait and Balance in Patients With Patellofemoral Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05629286
• Other study ID #: A-9230347
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Yildiz Analay Akbaba, Assoc. Prof.
• Phone: +905323774013
• Email: yildizanalay[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Device:
• McConnell taping
non-stretch rigid McConnell tape will be applied
• Patella Stabilizer Brace
An orthotic application that wraps the patellofemoral joint, which has a patellar cavity and supports the patella, and provides stabilization with velcro

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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:CD010387. doi: 10.1002/14651858.CD010387.pub2. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kujala Patellofemoral Scoring	It is a tool that allows functional evaluation in knee complaints due to patellofemoral structure.	up to three weeks
Primary	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	10 Stair Up Test	Participants will go up and down with both feet 10 times on a hard step 20 centimeters above the ground.	up to three weeks
Secondary	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.	up to three weeks
Secondary	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.	up to three weeks
Secondary	Single Leg Stance Test	Evaluates the standing balance of the participants.	up to three weeks
Secondary	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.	up to three weeks