Effects of Proximal Strengthening Exercises in Patellofemoral Pain Syndrome Among Basketball Players

January 28, 2024 updated by: Riphah International University

Effects of Proximal Strengthening Exercises on Pain and Function in Patellofemoral Pain Syndrome Among Basketball Players

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54782
        • Recruiting
        • Physio wellness centre
        • Contact:
        • Principal Investigator:
          • Allah Nawaz, DPT
        • Sub-Investigator:
          • Muhammad Asrar Yousaf, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Isolated Strengthening Exercises
Isolated strengthening exercises refers to set of exercises that are used to treat a specific part of body. In our study, isolated strengthening exercises including 10 repetition of 3 sets of legs extensions,10 repetition of 3 sets squats and 10 repetition of 3 sets lunges are used. These exercises aim to improve the pain and range of motion of knee by acting on quadriceps.
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.
Experimental: Combined Strengthening Exercises
The Combined strengthening group will perform the same isolated strengthening exercises, but with the addition of proximal strengthening exercises for the hip and core muscles. These exercises include 10 repetitions of bridging(3 sets), 10 repetitions of clamshells(2 sets), 10 repetition of 3 sets of legs extensions,10 repetition of 3 sets squats,10 repetition of 3 sets lunges and 10 repetitions of planks(2 sets).
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Single-legged hop tests
Time Frame: 6 weeks
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
Numeric pain rating scale
Time Frame: 6 weeks
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
Knee Injury and Osteoarthritis outcome score for Patellofemoral injury
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muhammad Asrar Yousaf, Phd, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/23/0430

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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