Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT07287267
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Relationship Between Range of Motion in Knee Rehabilitation Exercises and Pain in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (VAS)', 'timeFrame': 'Day 1 (Cross sectional single session. Outcomes will be collected during one single session for each participant.)', 'description': 'Pain measured 0-10 visual analog scale (VAS) reported during each trial of progressively increased range of motion during a single session.'}, {'measure': 'Range of motion', 'timeFrame': 'Day 1 (Cross sectional single session. Outcomes will be collected during one single session for each participant.)', 'description': 'Degrees of knee flexion measured during each trial in one single session.'}], 'secondaryOutcomes': [{'measure': 'Force', 'timeFrame': 'Day 1 (Cross sectional single session. Outcomes will be collected during one single session for each participant.)', 'description': 'Force (N) (peak value) reported during the different trials in one session. Measured by force plates.'}, {'measure': 'Tegner Activity Scale (TAS)', 'timeFrame': 'Baseline (Administered at the beginning of the study)', 'description': 'The Tegner Activity Scale (TAS) will be used to assess the physical activity levels of the participants. Scale from 1-10 where 10 is highest possible physical activity and 1 is sedentary.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patellofemoral pain syndrome', 'Range of motion', 'patellofemoral pain'], 'conditions': ['Patello Femoral Syndrome']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the relationship between knee joint range of motion and pain in patients with patellofemoral pain syndrome (PFPS). In a cross-sectional observational design, PFPS patients will perform trials involving progressively increased knee joint range of motion in three closed-chain exercises: squat, single-leg squat, and split squat. During each trial, participants will report pain levels on a 0-10 Visual Analog Scale (VAS) until either (1) achieving full depth in the respective exercise or (2) reaching a pain level of \\>5 on the VAS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This project will include patients diagnosed with PFP (ICD-10: M22.2).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with PFP in only one knee by a licensed healthcare professional.\n* Aged 15-35 years.\n* A physical activity level of 3/10 or higher on the Tegner Activity Scale before the injury.\n\nExclusion Criteria:\n\n* Any prior injury or condition with residual symptoms that may affect the results.\n* Current injury or condition affecting the performance of the test.\n* Resting pain greater than 0-1/10 on the Numeric Pain Rating Scale (NRS) and pain greater than 1-2/10 during light daily activities such as walking, sitting, standing, or climbing stairs.'}, 'identificationModule': {'nctId': 'NCT07287267', 'briefTitle': 'Exploring the Relationship Between Range of Motion in Knee Rehabilitation Exercises and Pain in Patellofemoral Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Linnaeus University'}, 'officialTitle': 'Exploring the Relationship Between Range of Motion in Knee Rehabilitation Exercises and Pain in Patellofemoral Pain Syndrome', 'orgStudyIdInfo': {'id': '2024-01422-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patellofemoral Pain Syndrome', 'description': 'Patients diagnosed with patellofemoral pain syndrome by health care provider.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Exercise with progressively increased range of motion.', 'armGroupLabels': ['Patellofemoral Pain Syndrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kalmar', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ted Gunhamn', 'role': 'CONTACT', 'email': 'ted.olssongunhamn@lnu.com', 'phone': '+46480-4977688'}], 'facility': 'Linnaues University', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ted Gunhamn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Ted Gunhamn', 'investigatorAffiliation': 'Linnaeus University'}}}}