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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04753333
Other study ID # DSRMajmaahU
Secondary ID 2020-26
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date February 28, 2021

Study information

Verified date September 2021
Source Majmaah University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 28, 2021
Est. primary completion date February 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Knee pain during activities such as descending and ascending stairs, squatting, and running, 2. Positive J sign (lateral tilt of patella), 3. Sign of patellar malalignment on radiograph. Exclusion Criteria: 1. Fracture around knee, 2. Patella dislocation, 3. Knee deformity (e.g., genu varum), 4. Knee flexion contracture, 5. Ligaments/meniscal injuries, and 6. Osteoarthritis of knee.

Study Design


Intervention

Behavioral:
Electromyography biofeedback (EMG-BF)
Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training with patellar taping
Sham electromyography biofeedback (EMG-BF)
Participants in this group will receive Sham electromyography biofeedback (EMG-BF) guided strength training without patellar taping

Locations

Country Name City State
Saudi Arabia Physiotherapy & Rehabilitation center Al Majma'ah Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Majmaah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). up to 6 weeks
Primary 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. up to 6 weeks
Primary 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. up to 6 weeks
See also
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Recruiting NCT05428332 - Spring Loaded Tri-Compartment Unloader Knee Brace Study N/A
Recruiting NCT06398535 - Ultrasound Versus Magnetic Reseonance Imaging(MRI) in the Assessment of Anterior Knee Pain