- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04753333
Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes (PFPS)
Efficacy of Electromyographic-biofeedback Supplementation Training on Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 60 adult male athletes aged 18 to 45 years will be recruited from two cities (Majmaah and Riyadh) of Saudi Arabia. Subjects will be included with the history of knee pain during activities such as descending and ascending stairs, squatting, and running, had positive J sign (lateral tilt of patella), and a sign of patellar malalignment on the radiograph. Individuals with the history of fracture around knee, patella dislocation, knee deformity (e.g., genu varum), flexion contracture, ligaments/meniscal injuries, and osteoarthritis of knee will be excluded from the study. The protocol was submitted to and approved by the ethical sub-committee of College of applied medical science, Majmaah, Saudi Arabia (Ethics number: MUREC-Nov./COM-2O20/11-2). Participants will be requested to sign a written informed consent form approved by the institution ethics committee.
Participants will be randomly assigned to Group A (experimental group): electromyography biofeedback (EMG-BF) guided maximum voluntary isometric contraction exercise with patellar taping; Group B (control group): sham EMG-BF guided maximum voluntary isometric contraction without patellar taping. The outcome measure for this study will be the mean changes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle, pain intensity, and functional status up to 6 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Riyadh
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Al Majma'ah, Riyadh, Saudi Arabia, 11952
- Physiotherapy & Rehabilitation center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Knee pain during activities such as descending and ascending stairs, squatting, and running,
- Positive J sign (lateral tilt of patella),
- Sign of patellar malalignment on radiograph.
Exclusion Criteria:
- Fracture around knee,
- Patella dislocation,
- Knee deformity (e.g., genu varum),
- Knee flexion contracture,
- Ligaments/meniscal injuries, and
- Osteoarthritis of knee.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
The participants in the experimental group will receive Electromyographic-biofeedback guided (EMG-BF) isometric quadriceps strengthening with patellar taping five days a week for four weeks.
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Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training with patellar taping
Other Names:
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Placebo Comparator: Control
The participants in the experimental group will receive Sham EMG-BF guided isometric quadriceps strengthening without patellar taping five days a week for four weeks.
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Participants in this group will receive Sham electromyography biofeedback (EMG-BF) guided strength training without patellar taping
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean changes in pain intensity
Time Frame: up to 6 weeks
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The 10-cm visual analogue scale (VAS) will be used for the assessment of pain intensity.
Each participant will be instructed to report their current intensity of pain on a 10-cm scale between two anchors 0 (indicates no pain) and 10 (indicates maximum pain).
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up to 6 weeks
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Mean changes in knee function
Time Frame: up to 6 weeks
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Knee function will be assessed using the validated Anterior Knee Pain scale.
It comprised of 13 questions designed to evaluate difficulties related to PFPS such as presence of a limp, walking ability, need for support, squatting, stair climbing, jumping, running, pain, abnormal painful kneecap movement, prolonged sitting with knees flexed, atrophy of the thigh, swelling, and flexion deficiency.
Total scores range between 0 and 100.
A higher score suggests lower symptoms and better functional capacity.
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up to 6 weeks
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Mean changes in quadriceps muscle strength
Time Frame: up to 6 weeks
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Maximum voluntary isometric strength of quadriceps femoris muscle will be measured using an isokinetic dynamometer.
Participants will be made in a sitting position and secured using the stabilization straps with the knee joint in 60 degrees of flexion, as this position has resulted in the most significant torque output.
They will be verbally encouraged to carry out three maximal voluntary isometric contractions of quadriceps with 5-sec rest.
The best of the three maximum peak torque will be used for the analysis.
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up to 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shahnaz Hasan, PhD, Majmaah University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSRMajmaahU
- 2020-26 (DSR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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