Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
Study NCT ID:
NCT06758050
Status:
RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-12-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Core Exercises on Patellofemoral Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2024-12-26', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '6 weeks', 'description': 'by Visual analog scale'}, {'measure': 'knee function', 'timeFrame': '6 weeks', 'description': 'by Anterior knee pain scale ( AKPS) ( Kujala )'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '6 weeks', 'description': 'By hand held dynamometer'}, {'measure': 'Balance', 'timeFrame': '6 weeks', 'description': 'By Biodex balance system'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['core strengthening exercises, hip and knee-focused exercises, patellofemoral pain syndrome'], 'conditions': ['Patellofemoral Pain Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSubjects 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.\n\nHypotheses:\n\nIt will be hypothesized that:\n\n1. There is no effect of core strengthening exercises on pain in treating PFPS.\n2. There is no effect of core strengthening exercises on muscle strength in treating PFPS.\n3. There is no effect of core strengthening exercises on function in treating PFPS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of both genders with an age range of 18- 35 years old.\n2. Gradual development of pain in the front of the knee lasting more than 12 weeks.\n3. Patients with body mass index 18- 25 kg m2.\n4. Pain is aggravated by at least 2 of the following activities: jumping, running, prolonged sitting, stair climbing, kneeling, and squatting.\n\n 1. Positive patellar grinding test.\n 2. Insidious onset of symptoms, unrelated to a traumatic damage.\n\nExclusion Criteria:\n\n1. Traumatic patellar subluxation or dislocation.\n2. A history of any of the following conditions: meniscal or other intra articular pathologic conditions; cruciate or collateral ligament involvement.\n3. Any lower limb bony or congenital deformities.\n4. Previous knee and hip joint surgeries.\n5. Osteoarthritis in the ankle, knee, or hip joints.\n6. Conditions that affect muscle strength such as diabetes mellitus or rheumatoid arthritis.'}, 'identificationModule': {'nctId': 'NCT06758050', 'briefTitle': 'Effect of Core Exercises on Patellofemoral Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Adding Core Exercises to Hip and Knee-focused Exercises on Patellofemoral Pain Syndrome', 'orgStudyIdInfo': {'id': 'No:P.T.REC/012/005347'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': '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.\n\nDuring 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.', 'interventionNames': ['Other: Core strengthening exercises', 'Other: Traditional treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Group A (control group) (evidence-based approaches group): The participants in the control group will receive only a hip and knee- focused exercise program.\n\n1. 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.\n2. 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).', 'interventionNames': ['Other: Traditional treatment']}], 'interventions': [{'name': 'Core strengthening exercises', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['Study group']}, {'name': 'Traditional treatment', 'type': 'OTHER', 'description': 'hip and knee-focused exercises', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Rana Ibrahim, Bachelor', 'role': 'CONTACT', 'email': 'ranaibrahim066@gmail.com', 'phone': '01151082787'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Rana Ibrahim Ahmed, Bachelor Physical Therapy-MUST', 'role': 'CONTACT', 'email': 'ranaibrahim066@gmail.com', 'phone': '01151082787'}], 'overallOfficials': [{'name': 'rana ibrahim ahmed, Bachelor Physical Therapy-MUST', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misr University for Science and Technology'}, {'name': 'Nasr Awad Abd Elkader, Assistant Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Physical Therapy for Musculoskeletal Disorders and its Surgeries Faculty of Physical Therapy Cairo University'}, {'name': 'Abdelgalil Allam Abdelgalil, Lecturer of Physical Therapy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physical Therapy for Musculoskeletal Disorders and its Surgeries Faculty of Physical Therapy Cairo University'}, {'name': 'Mohammed Safwat Hamza, Associate Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine Misr University for Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rana Ibrahim Ahmed Mahmoud', 'investigatorFullName': 'Rana Ibrahim', 'investigatorAffiliation': 'Cairo University'}}}}