Patellofemoral Pain SyndromeNCT06758050
Effect of Core Exercises on Patellofemoral Pain Syndrome
A study testing Core strengthening exercises and Traditional treatment in people with Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
the goal of this interventional study is to Investigate the effect of core strengthening exercises on pain, strength, function, and balance in patients with PFPS. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Core strengthening exercises and Traditional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Aug 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both genders with an age range of 18- 35 years old.
- Gradual development of pain in the front of the knee lasting more than 12 weeks.
- Patients with body mass index 18- 25 kg m2.
- Pain is aggravated by at least 2 of the following activities: jumping, running, prolonged sitting, stair climbing, kneeling, and squatting.
- Positive patellar grinding test.
- Insidious onset of symptoms, unrelated to a traumatic damage.
Who cannot join
- Traumatic patellar subluxation or dislocation.
- A history of any of the following conditions: meniscal or other intra articular pathologic conditions; cruciate or collateral ligament involvement.
- Any lower limb bony or congenital deformities.
- Previous knee and hip joint surgeries.
- Osteoarthritis in the ankle, knee, or hip joints.
- Conditions that affect muscle strength such as diabetes mellitus or rheumatoid arthritis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza
Rana Ibrahim, Bachelor, 01151082787, ranaibrahim066@gmail.com
About this study
Official title: Effect of Adding Core Exercises to Hip and Knee-focused Exercises on Patellofemoral Pain Syndrome
the goal of this interventional study is to Investigate the effect of core strengthening exercises on pain, strength, function, and balance in patients with PFPS.
Read the detailed description
Purpose: Patellofemoral pain syndrome is a frequent musculoskeletal disorder, which can result from core muscles instability that can lead to pain, function and altered dynamic balance. The objective of this study is to assess the effect of core muscle strengthening on pain, function, strength and dynamic balance in patients with patellofemoral pain syndrome.
Subjects and Methods: Forty-four patients with age ranging from 18 to 35 years with patellofemoral pain syndrome will be divided into study (N=22) and control (N=22) groups. Both groups will be given 6 weeks of conventional physical therapy program and an additional core muscle strengthening for the study group. The tools are being used to assess the outcome are 1- Visual Analogue Scale,2- handheld dynamometer,3-AKPS 4- BIODEX Balance.
Hypotheses:
It will be hypothesized that:
- There is no effect of core strengthening exercises on pain in treating PFPS.
- There is no effect of core strengthening exercises on muscle strength in treating PFPS.
- There is no effect of core strengthening exercises on function in treating PFPS.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Core strengthening exercises, Traditional treatment
- Keywords
- core strengthening exercises, hip and knee-focused exercises, patellofemoral pain syndrome
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core strengthening exercisesOther
By core strengthening exercise, could be improved pain, balance, and function in patients with patellofemoral pain syndrome. In that case, this will not only improve their postural stability and neuromuscular control, but we believe it will improve their overall functional, performance, and quality of life. Currently, limited evidence exists about the effectiveness of core strengthening exercises on pain, function and dynamic balance in patellofemoral pain syndrome. By addressing core strengthening exercise, physical therapists can advise new treatment methods for patellofemoral pain syndrome (Chevidikunnan et al., 2016)
Traditional treatmentOther
hip and knee-focused exercises
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Group B (study group) (core strengthening exercises added to evidence-based approaches group) The core muscle strength training program The core muscle strength training program will last for 6 weeks and comprise of two training sessions per week, with a total of 12 sessions for the study group.
During the main part of the training, the "big 3" exercises as described by McGill will be conducted. These include the curl-up, side bridge, and quadruped position. Receives: Other: Core strengthening exercises; Other: Traditional treatment |
| Control group | Active comparator | Group A (control group) (evidence-based approaches group): The participants in the control group will receive only a hip and knee- focused exercise program.
1. Hip-focused exercise: Based on previous studies, hip-focused exercises will consist of side- lying hip abduction, hip external rotation (clamshell), and prone hip extension.
2. Knee-focused exercise The knee-focused exercise regime will be based on previous studies and consist of supine straight leg raises, supine terminal knee extensions (from 10° flexion to full extension), and a mini squat (45° flexion) with the back supported against the wall (to reduce stabilizing requirements from the hip muscles). Receives: Other: Traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
by Visual analog scale
Measured: 6 weeks
knee function
by Anterior knee pain scale ( AKPS) ( Kujala )
Measured: 6 weeks
Secondary outcomes (2)
Muscle strength
By hand held dynamometer
Measured: 6 weeks
Balance
By Biodex balance system
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 posted3 Jan 2025
- Study start4 Aug 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Ibrahim, Cairo University
- Investigators
- rana ibrahim ahmed, Bachelor Physical Therapy-MUST, Principal investigator, Misr University for Science and TechnologyNasr Awad Abd Elkader, Assistant Professor, Study chair, Physical Therapy for Musculoskeletal Disorders and its Surgeries Faculty of Physical Therapy Cairo UniversityAbdelgalil Allam Abdelgalil, Lecturer of Physical Therapy, Study director, Physical Therapy for Musculoskeletal Disorders and its Surgeries Faculty of Physical Therapy Cairo UniversityMohammed Safwat Hamza, Associate Professor, Study director, Faculty of Medicine Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758050
- Sponsor's protocol ID
- No:P.T.REC/012/005347
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Core Exercises to Hip and Knee-focused Exercises on Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT06758050
- Acronym / sponsor ID
- No:P.T.REC/012/005347
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- core strengthening exercises, hip and knee-focused exercises, patellofemoral pain syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 3 Jan 2025 (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.
the goal of this interventional study is to Investigate the effect of core strengthening exercises on pain, strength, function, and balance in patients with PFPS.
Detailed description
Purpose: Patellofemoral pain syndrome is a frequent musculoskeletal disorder, which can result from core muscles instability that can lead to pain, function and altered dynamic balance. The objective of this study is to assess the effect of core muscle strengthening on pain, function, strength and dynamic balance in patients with patellofemoral pain syndrome.
Subjects and Methods: Forty-four patients with age ranging from 18 to 35 years with patellofemoral pain syndrome will be divided into study (N=22) and control (N=22) groups. Both groups will be given 6 weeks of conventional physical therapy program and an additional core muscle strengthening for the study group. The tools are being used to assess the outcome are 1- Visual Analogue Scale,2- handheld dynamometer,3-AKPS 4- BIODEX Balance.
Hypotheses:
It will be hypothesized that:
- There is no effect of core strengthening exercises on pain in treating PFPS.
- There is no effect of core strengthening exercises on muscle strength in treating PFPS.
- There is no effect of core strengthening exercises on function in treating PFPS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Core strengthening exercises, Other: Traditional treatmentGroup B (study group) (core strengthening exercises added to evidence-based approaches group) The core muscle strength training program The core muscle strength training program will last for 6 weeks and comprise of two training sessions per week, with a total of 12 sessions for the study group. During the main part of the training, the "big 3" exercises as described by McGill will be conducted. These include the curl-up, side bridge, and quadruped position. |
| Control group | Active comparator | Other: Traditional treatmentGroup A (control group) (evidence-based approaches group): The participants in the control group will receive only a hip and knee- focused exercise program. 1. Hip-focused exercise: Based on previous studies, hip-focused exercises will consist of side- lying hip abduction, hip external rotation (clamshell), and prone hip extension. 2. Knee-focused exercise The knee-focused exercise regime will be based on previous studies and consist of supine straight leg raises, supine terminal knee extensions (from 10° flexion to full extension), and a mini squat (45° flexion) with the back supported against the wall (to reduce stabilizing requirements from the hip muscles). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients of both genders with an age range of 18- 35 years old.
- Gradual development of pain in the front of the knee lasting more than 12 weeks.
- Patients with body mass index 18- 25 kg m2.
- Pain is aggravated by at least 2 of the following activities: jumping, running, prolonged sitting, stair climbing, kneeling, and squatting.
Key exclusion criteria (6 listed)
- Traumatic patellar subluxation or dislocation.
- A history of any of the following conditions: meniscal or other intra articular pathologic conditions; cruciate or collateral ligament involvement.
- Any lower limb bony or congenital deformities.
- Previous knee and hip joint surgeries.
- Osteoarthritis in the ankle, knee, or hip joints.
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 |
|---|---|---|
| Core strengthening exercisesBy core strengthening exercise, could be improved pain, balance, and function in patients with patellofemoral pain syndrome. In that case, this will not only improve their postural stability and neuromuscular control, but we believe it will improve their overall functional, performance, and quality of life. Currently, limited evidence exists about the effectiveness of core strengthening exercises on pain, function and dynamic balance in patellofemoral pain syndrome. By addressing core strengthening exercise, physical therapists can advise new treatment methods for patellofemoral pain syndrome (Chevidikunnan et al., 2016) | Other | Study group |
| Traditional treatmenthip and knee-focused exercises | Other | Control group, Study group |
Primary outcome
Pain
Time frame: 6 weeks
by Visual analog scale
knee function
Time frame: 6 weeks
by Anterior knee pain scale ( AKPS) ( Kujala )
2 secondary outcomes
Muscle strength
Time frame: 6 weeks
Balance
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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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.
rana ibrahim ahmed, Bachelor Physical Therapy-MUST principal investigator
Misr University for Science and Technology
Nasr Awad Abd Elkader, Assistant Professor study chair
Physical Therapy for Musculoskeletal Disorders and its Surgeries Faculty of Physical Therapy Cairo University
Abdelgalil Allam Abdelgalil, Lecturer of Physical Therapy study director
Physical Therapy for Musculoskeletal Disorders and its Surgeries Faculty of Physical Therapy Cairo 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 Core strengthening exercises and Traditional treatment in people with Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Jan 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rana Ibrahim Ahmed, Bachelor Physical Therapy-MUST (01151082787, ranaibrahim066@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2025.