Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT04753333
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2021-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental: Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training along with patellar taping\n\nNo Intervention: Control: Participants in this group will receive Sham EMG-BF guided strength training without patellar taping'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean changes in pain intensity', 'timeFrame': 'up to 6 weeks', '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).'}, {'measure': 'Mean changes in knee function', 'timeFrame': 'up to 6 weeks', '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.'}, {'measure': 'Mean changes in quadriceps muscle strength', 'timeFrame': 'up to 6 weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain; Strength; Function; PFPS; Athletes; Young adults'], 'conditions': ['Patellofemoral Disorder', 'Anterior Knee Pain']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Knee pain during activities such as descending and ascending stairs, squatting, and running,\n2. Positive J sign (lateral tilt of patella),\n3. Sign of patellar malalignment on radiograph.\n\nExclusion Criteria:\n\n1. Fracture around knee,\n2. Patella dislocation,\n3. Knee deformity (e.g., genu varum),\n4. Knee flexion contracture,\n5. Ligaments/meniscal injuries, and\n6. Osteoarthritis of knee.'}, 'identificationModule': {'nctId': 'NCT04753333', 'acronym': 'PFPS', 'briefTitle': 'Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Majmaah University'}, 'officialTitle': 'Efficacy of Electromyographic-biofeedback Supplementation Training on Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes', 'orgStudyIdInfo': {'id': 'DSRMajmaahU'}, 'secondaryIdInfos': [{'id': '2020-26', 'type': 'OTHER_GRANT', 'domain': 'DSR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', '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.', 'interventionNames': ['Behavioral: Electromyography biofeedback (EMG-BF)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', '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.', 'interventionNames': ['Behavioral: Sham electromyography biofeedback (EMG-BF)']}], 'interventions': [{'name': 'Electromyography biofeedback (EMG-BF)', 'type': 'BEHAVIORAL', 'otherNames': ['Patellar Taping'], 'description': 'Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training with patellar taping', 'armGroupLabels': ['Experimental']}, {'name': 'Sham electromyography biofeedback (EMG-BF)', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will receive Sham electromyography biofeedback (EMG-BF) guided strength training without patellar taping', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11952', 'city': "Al Majma'ah", 'state': 'Riyadh Region', 'country': 'Saudi Arabia', 'facility': 'Physiotherapy & Rehabilitation center', 'geoPoint': {'lat': 25.91097, 'lon': 45.35665}}], 'overallOfficials': [{'name': 'Shahnaz Hasan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Majmaah University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be kept secure with the principal investigator (Dr. Asma Alonazi) and sub-investigator (Dr. Shahnaz Hasan) due to confidentiality issues'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Majmaah University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shahnaz Hasan, PhD', 'investigatorAffiliation': 'Majmaah University'}}}}