Patellofemoral SyndromeNCT06131710
Effects of Proximal Strengthening Exercises in Patellofemoral Pain Syndrome Among Basketball Players
A study testing Isolated Strengthening Exercises and Combined Strengthening Exercises in people with Patellofemoral Syndrome, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Syndrome
- What is being tested?
- Isolated Strengthening Exercises and Combined Strengthening Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2023to 5 Feb 2024
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Physio wellness centre
Lahore, Punjab Province, 54782
Sana Sarwar, DPT, 03324027932, phstherapist@gmail.com
Allah Nawaz, DPT
About this study
Official title: 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.
Read the 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.
- Conditions
- Patellofemoral Syndrome
- Being tested
- Isolated Strengthening Exercises, Combined Strengthening Exercises
- Keywords
- Clamshell, Isolated exercise, Pain, Patellofemoral syndrome, Squat
- Medical subject headings
- Patellofemoral Pain Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated Strengthening ExercisesOther
Isolated strengthening exercises can be beneficial for individuals with Patellofemoral Pain Syndrome (PFPS) to help address muscle imbalances and alleviate pain.
Combined Strengthening ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Isolated Strengthening Exercises | Experimental | 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. Receives: Other: Isolated Strengthening Exercises |
| Combined Strengthening Exercises | Experimental | 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). Receives: Other: Isolated Strengthening Exercises; Other: Combined Strengthening Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start5 May 2023
- Primary completion5 Feb 2024 (estimated)
- Study completion5 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Asrar Yousaf, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131710
- Sponsor's protocol ID
- REC/RCR & AHS/23/0430
- Status last verified
- Jan 2024
- First submitted
- 9 Nov 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2024 Apr;40(4):843-855. doi: 10.1080/09593985.2022.2158053. Epub 2022 Dec 19.
PubMed 36537113You 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.
PubMed 36984590
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proximal Strengthening Exercises on Pain and Function in Patellofemoral Pain Syndrome Among Basketball Players
- ClinicalTrials.gov ID
- NCT06131710
- Acronym / sponsor ID
- REC/RCR & AHS/23/0430
- Conditions
- Patellofemoral Syndrome
- Keywords
- Clamshell, Isolated exercise, Pain, Patellofemoral syndrome, Squat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 5 Feb 2024 (estimated)
- Study completion
- 5 Feb 2024 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated Strengthening Exercises | Experimental | Other: Isolated Strengthening ExercisesIsolated 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. |
| Combined Strengthening Exercises | Experimental | Other: Isolated Strengthening Exercises, Other: Combined Strengthening ExercisesThe 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolated Strengthening ExercisesIsolated strengthening exercises can be beneficial for individuals with Patellofemoral Pain Syndrome (PFPS) to help address muscle imbalances and alleviate pain. | Other | Combined Strengthening Exercises, Isolated Strengthening Exercises |
| Combined Strengthening ExercisesCombined 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. | Other | Combined Strengthening Exercises |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 36537113Mostafaee 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. 2024 Apr;40(4):843-855. doi: 10.1080/09593985.2022.2158053. Epub 2022 Dec 19.
- Background: PubMed 36984590You 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Asrar Yousaf, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated Strengthening Exercises and Combined Strengthening Exercises in people with Patellofemoral Syndrome, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Jan 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Asrar Yousaf, Phd (03004099505, asrar.yousaf@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 6 weeks). The study lists 3 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 NCT06131710, which also lists 2 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 30 Jan 2024.