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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06131710
Other study ID # REC/RCR & AHS/23/0430
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 5, 2023
Est. completion date February 5, 2024

Study information

Verified date January 2024
Source Riphah International University
Contact Muhammad Asrar Yousaf, Phd
Phone 03004099505
Email asrar.yousaf@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study aims to compare the effectiveness of two different exercise approaches in treating Patellofemoral Pain Syndrome (PFPS) in basketball players. It employs a randomized clinical trial with 32 participants aged 18-40 diagnosed with PFPS. The participants are divided into two groups: Isolated Strengthening Exercises (ISE) and Combined Strengthening Exercises (CSE). The ISE group focuses solely on quadriceps strengthening exercises, while the CSE group incorporates both quadriceps and proximal strengthening exercises for the hip and core muscles. Outcome measures include pain levels, functionality, and physical performance assessments recorded at baseline and after 6 weeks. Statistical analysis using independent t-tests in SPSS will determine which approach is more effective. This study seeks to provide evidence on whether the combination of proximal strengthening exercises enhances the reduction of pain and improvement in functionality for basketball players with PFPS, compared to isolated strengthening exercises alone.


Description:

Patellofemoral Pain Syndrome (PFPS) is a common knee condition that affects basketball players and can lead to significant pain and functional limitations. The syndrome involves pain around or behind the patella (kneecap) due to malalignment and abnormal tracking of the patella within the femoral groove. Isolated strengthening exercises targeting the quadriceps have been widely recommended as a treatment approach for PFPS. However, recent research suggests that incorporating proximal strengthening exercises, focusing on the hip and core muscles, may enhance treatment outcomes. This study aims to investigate the comparative effectiveness of isolated strengthening exercises alone versus combined with proximal strengthening exercises in reducing pain and improving functionality in basketball players with PFPS. This research will employ a randomized clinical trial design to assess the impact of different strengthening exercise protocols on pain and functionality among basketball players diagnosed with PFPS. A sample of 32 basketball players aged 18-40 years, diagnosed with PFPS by a qualified orthopedic specialist and physiotherapists will be recruited for the study. Participants will be randomly assigned into two groups: The Isolated Strengthening Exercises (ISE) group and the Combined Strengthening Exercises (CSE) group, which includes both isolated and proximal strengthening exercises. The ISE group will follow a structured program consisting of isolated strengthening exercises targeting the quadriceps, focusing on exercises such as leg extensions, squats, and lunges. The CSE group will perform the same isolated strengthening exercises but with the addition of proximal strengthening exercises for the hip and core muscles, including exercises such as hip abduction, clamshells, and planks. Outcome measures, including pain levels using NPRS, functionality using the KOOS-PF, Step-down test, single leg squat Hop test, and range of motion assessments, will be recorded at baseline after 6 weeks. Statistical analysis, including independent t-tests, will be performed to compare the outcomes between the ISE and CSE groups using SPSS version 26.0.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion criteria: - Professional male basketball players of the age group 18-40 years - Practicing players of basketball (3-5 times a week) - Players who experience pain around Patella - Pain severity between 3 and 10 during stair descending test for PFPS - Positive diagnostic patellofemoral syndrome maneuvers including Shrug test, Grind test and Perkins test Exclusion criteria: - Past surgery of affected leg - Systemic illness (diabetes, systemic lupus erythematosus) - Individuals havening significant knee pathologies such as ACL tear, Meniscal tear - Referred pain originating from other points of body - Knee deformities or signs of knee OA in knee x-ray

Study Design


Intervention

Other:
Isolated Strengthening Exercises
Isolated strengthening exercises can be beneficial for individuals with Patellofemoral Pain Syndrome (PFPS) to help address muscle imbalances and alleviate pain.
Combined Strengthening Exercises
Combined strengthening exercises for Patellofemoral Pain Syndrome (PFPS) typically include a mix of quadriceps strengthening exercises, hip strengthening exercises, and core stability exercises. The goal is to address muscle imbalances and improve the overall stability of the knee joint.

Locations

Country Name City State
Pakistan Physio wellness centre Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

Mostafaee N, Pashaei-Marandi M, Negahban H, Pirayeh N, Saki Malehi A, Ebrahimzadeh MH. Examining the diagnostic accuracy of common physical examination and functional tests in the diagnosis of patellofemoral pain syndrome among patients with anterior knee pain. Physiother Theory Pract. 2022 Dec 19:1-13. doi: 10.1080/09593985.2022.2158053. Online ahead of print. — View Citation

You S, Shen Y, Liu Q, Cicchella A. Patellofemoral Pain, Q-Angle, and Performance in Female Chinese Collegiate Soccer Players. Medicina (Kaunas). 2023 Mar 16;59(3):589. doi: 10.3390/medicina59030589. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale The Numeric pain rating scale is a self-reported, or clinician-administered, measurement tool consisting of a numerical point scale with extreme anchors of no pain to extreme pain. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form. The 0 on scale shows no pain, 1-4 shows mild pain, 5 and 6 shows moderate pain and 7-10 shows severe pain. 6 weeks
Primary Knee Injury and Osteoarthritis outcome score for Patellofemoral injury Knee Injury and Osteoarthritis Outcome Score Patellofemoral is one subjective type of questionnaire developed as an extension with the aim of estimating the immediate and long-term symptoms and function among people with Patellofemoral pain syndrome. Higher scores show pain severity whereas lower score shows mild or no pain. 6 weeks
Primary Single-legged hop tests Single-legged hop tests are functional tests that have been used to identify individuals who can regain dynamic knee stability after an ACL injury. 6 weeks
See also
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