Effectiveness of Neuromuscular Exercise in Patellofemoral Pain Syndrome

Patellofemoral Pain Syndrome Clinical Trial

Official title:

The Effect of Neuromuscular Exercise Program on Strength, Balance, Sleep Quality and Functionality in Patellofemoral Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407414
• Other study ID #: Uskudar8
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: May 2024
• Source: Uskudar University
• Contact: Ömer SEVGIN
• Phone: +905069787535
• Email: omer.sevgin[@]uskudar.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate the effects of a neuromuscular exercise program on strength, balance, sleep quality and functionality in individuals with Patellofemoral pain syndrome.

Description:

The research is planned as a quantitative study. Classical knee exercises will be given to 25 individuals in the control group of the study. An exercise program consisting of Neuromuscular exercises will be applied to 25 individuals in the intervention group. In data collection, strength and balance measurements will be measured face to face by a physiotherapist, and the scales to be made through a survey will be sent to the patients online and they will be asked to fill them out. The scales and forms to be used are as follows: 1.Kujala Patellofemoral Score Scale 2.Lysholm Knee Scoring Scale 3.International Physical Activity Survey 4.Pittsburgh Sleep Quality Index 5.Y Balance Test 6.30 Seconds Sit and Stand Test Applied scales will be done by the physiotherapist. The surveys will be uploaded to the Google Forms database and the participants will be contacted via e-mail or mobile phone applications (such as Whatsapp, Telegram) to participate. They will first be asked to fill out the surveys before starting the exercise program and they will be asked to apply the exercise program. It will be explained as follows. Exercises will be planned 3 times a week and for 12 weeks. Participants will be asked to participate in the survey again after completing the exercise program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 15, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Volunteering to participate in the study.

• Not under 30 years of age and not over 60 years of age.

• Having patellofemoral pain syndrome.

• Not having a physical disability.

• Not having undergone any knee-related surgery.

• Having access to a computer/tablet/phone and the internet.

Exclusion Criteria:

• Not accepting the voluntary consent form.

• Being under 30 years of age and over 60 years of age.

• Having undergone any knee-related surgery.

• Having cognitive, mental or psychological problems.

• Having impaired vision or hearing.

• Having a physical condition that causes significant loss of function.

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Other:
• control
classical physiotherapy methods
• Exercise
In addition to classical physiotherapy methods, neuromuscular exercise protocol will be applied.

Locations

Country	Name	City	State
Turkey	Uskudar University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Basbug P, Kilic RT, Atay AO, Bayrakci Tunay V. The effects of progressive neuromuscular exercise program and taping on muscle strength and pain in patellofemoral pain. A randomized controlled blind study. Somatosens Mot Res. 2022 Mar;39(1):39-45. doi: 10.1080/08990220.2021.1987877. Epub 2021 Oct 29. — View Citation

Kim S, Roh Y, Glaviano NR, Park J. Quadriceps Neuromuscular Function During and After Exercise-Induced Fatigue in Patients With Patellofemoral Pain. J Athl Train. 2023 Jun 1;58(6):554-562. doi: 10.4085/1062-6050-0348.22. — View Citation

Kolle T, Alt W, Wagner D. Effects of a 12-week home exercise therapy program on pain and neuromuscular activity in patients with patellofemoral pain syndrome. Arch Orthop Trauma Surg. 2020 Dec;140(12):1985-1992. doi: 10.1007/s00402-020-03543-y. Epub 2020 Jul 29. — View Citation

Rathleff MS, Samani A, Olesen JL, Roos EM, Rasmussen S, Madeleine P. Effect of exercise therapy on neuromuscular activity and knee strength in female adolescents with patellofemoral pain-An ancillary analysis of a cluster randomized trial. Clin Biomech (Bristol, Avon). 2016 May;34:22-9. doi: 10.1016/j.clinbiomech.2016.03.002. Epub 2016 Mar 11. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kujala Patellofemoral Score Scale	Kujala patellofemoral scoring is a tool that allows functional evaluation of knee complaints related to the patellofemoral structure. Different scoring systems have been developed for knee-specific symptoms; however, only a few of these are focused on patellofemoral pain.The Kujala Patellofemoral Score Scale is graded on a scale of 0 to 100, with 100 being the highest possible score.	14 weeks
Primary	Lysholm Knee Scoring Scale	The Lysholm knee scoring scale is a global assessment tool that reflects overall functional outcome and physical activity level. The Lysholm scale is an 8-item questionnaire originally designed to assess knee function after knee ligament injuries. It was later confirmed for other knee conditions. Items evaluated according to the Lysholm scale include pain, type of support, instability, locking, swelling, limping, climbing stairs, and squatting. All items are scored to yield a score of 1, ranging from 0 to 100, with a higher Lysholm score indicating a lower level of symptoms and a higher level of functioning (91-100 = excellent, 84-90 = good, 65-83 = fair).	14 weeks
Primary	International Physical Activity Survey	Provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent(MET) -minute score. Standard metabolic equivalent (MET) values have been established for these activities.	14 weeks
Primary	Pittsburgh Sleep Quality Index	The pittsburgh Sleep Quality Index is a quantitative measure of sleep quality to define good and bad sleep. It includes 24 questions in total. The self-assessment questions include various items related to sleep quality. The total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence of sleep disturbances or the prevalence of sleep disturbances. However, a pittsburgh Sleep Quality Index total score of five or more indicates poor sleep quality	14 weeks
Primary	Y Balance Test	Y balance test is a simple but reliable test used to measure dynamic balance. The Y balance test is a dynamic test performed in a one-legged stance that requires strength, flexibility, core control and proprioception. It has been used to evaluate physical performance, demonstrate functional symmetry, and identify athletes at higher risk for lower extremity injury. With the test complete and all performances recorded, the test administrator can then calculate the athlete's Y Balance Test performance scores using any of, or all of, the following three equations: Absolute reach distance (cm) = (Reach 1 + Reach 2 + Reach 3) / 3 Relative (normalised) reach distance (%) = Absolute reach distance / limb length * 100 Composite reach distance (%) = Sum of the 3 reach directions / 3 times the limb length * 100	14 weeks
Primary	30 Second Sit and Stand Test	It is a test that evaluates the patient's sitting and standing activity, lower extremity strength and dynamic balance. The number of times the patient sits and stands within 30 seconds gives the score of the test. For this test performed to determine leg strength; A straight-backed chair with a seating height of 43.18cm (12-in) and no armrests is used. The individual is asked to sit in the middle of the chair with his back upright, his feet on the ground, and his arms crossed in front of his chest (right hand on the left shoulder, left hand on the right shoulder). While in this position, the individual starts the test with the start command and takes off as fully as he can during 30 seconds. The number of complete starts he makes during 30 seconds constitutes the subject's score.	14 weeks