Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes (PFPS)
Primary Purpose
Patellofemoral Disorder, Anterior Knee Pain
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Electromyography biofeedback (EMG-BF)
Sham electromyography biofeedback (EMG-BF)
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Disorder focused on measuring Pain; Strength; Function; PFPS; Athletes; Young adults
Eligibility Criteria
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.
Sites / Locations
- Physiotherapy & Rehabilitation center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mean changes in pain intensity
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).
Mean changes in knee function
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.
Mean changes in quadriceps muscle strength
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04753333
First Posted
January 22, 2021
Last Updated
September 14, 2021
Sponsor
Majmaah University
1. Study Identification
Unique Protocol Identification Number
NCT04753333
Brief Title
Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes
Acronym
PFPS
Official Title
Efficacy of Electromyographic-biofeedback Supplementation Training on Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Majmaah University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to investigate the effects of electromyography biofeedback (EMG-BF) guided isometric quadriceps strengthening with patellar taping and isometric exercise alone in young adult male athletes with patellofemoral pain syndrome (PFPS).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Disorder, Anterior Knee Pain
Keywords
Pain; Strength; Function; PFPS; Athletes; Young adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental: Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training along with patellar taping
No Intervention: Control: Participants in this group will receive Sham EMG-BF guided strength training without patellar taping
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Electromyography biofeedback (EMG-BF)
Other Intervention Name(s)
Patellar Taping
Intervention Description
Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training with patellar taping
Intervention Type
Behavioral
Intervention Name(s)
Sham electromyography biofeedback (EMG-BF)
Intervention Description
Participants in this group will receive Sham electromyography biofeedback (EMG-BF) guided strength training without patellar taping
Primary Outcome Measure Information:
Title
Mean changes in pain intensity
Description
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).
Time Frame
up to 6 weeks
Title
Mean changes in knee function
Description
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.
Time Frame
up to 6 weeks
Title
Mean changes in quadriceps muscle strength
Description
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.
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahnaz Hasan, PhD
Organizational Affiliation
Majmaah University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy & Rehabilitation center
City
Al Majma'ah
State/Province
Riyadh
ZIP/Postal Code
11952
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be kept secure with the principal investigator (Dr. Asma Alonazi) and sub-investigator (Dr. Shahnaz Hasan) due to confidentiality issues
Learn more about this trial
Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes
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