Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT07139158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Muscle Oxygenation in Patellofemoral Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-17', 'studyFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-08-17', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Oxygenation', 'timeFrame': 'Day 1', 'description': 'Vastus medialis muscle oxygenation will be evaluated with Near-Infrared Spectroscopy at rest, during and after activity.'}], 'secondaryOutcomes': [{'measure': 'Kujala Patellofemoral Score Scale', 'timeFrame': 'Day 1', 'description': 'Kujala patellofemoral scoring is a tool that allows functional evaluation of knee complaints related to the patellofemoral structure. Different scoring systems have been developed for knee-specific symptoms; however, only a few of these are focused on patellofemoral pain.The Kujala Patellofemoral Score Scale is graded on a scale of 0 to 100, with 100 being the highest possible score.'}, {'measure': 'International Physical Activity Questionnaire (IPAQ)', 'timeFrame': 'Day 1', 'description': 'Provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent(MET) -minute score. Standard metabolic equivalent (MET) values have been established for these activities.'}, {'measure': 'Adipose tissue thickness', 'timeFrame': 'Day 1', 'description': 'The skinfold thickness of vastus medialis muscle was evaluated with a Skinfold Caliper. Adipose tissue thickness was obtained by dividing the skinfold thickness by two.'}, {'measure': 'Numeric Pain Rating Scale', 'timeFrame': 'Day 1', 'description': 'Numeric pain rating scale is a scale used to quantify pain intensity. It is divided into eleven equal parts; for example 0 - 10. O means that there is no pain at all, 1 - 3 divisional range falls in the mild category pain , 4 - 6 indicates the symptoms of moderate pain while 7 - 10 reading symptoms the severity of pain.'}, {'measure': 'Tampa Kinesiophobia Scale', 'timeFrame': 'Day 1', 'description': 'The Tampa Kinesiophobia Scale is a 17-question questionnaire that assesses avoidance of injury and fear of movement. The scale is scored using a Likert scale (1 = Strongly disagree, 4 = Strongly agree). Items 4, 8, 12 and 16 are reversed to calculate the total score of the scale. The total score is between 17 and 68. As the score of the person increases, it is understood that their kinesiophobia is high. A total score higher than 37 is considered as high kinesiophobia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patellofemoral pain', 'near-infrared spectroscopy', 'lower extremity', 'kinesiophobia', 'physical activity'], 'conditions': ['Patellofemoral Pain, PFP']}, 'descriptionModule': {'briefSummary': "Patellofemoral joint problems account for a significant portion of knee pain and disability. Among these problems, patellofemoral pain is not directly related to any obvious structural abnormality and is characterized by pain in the retro- or peri-patellar region, particularly during activities such as squatting, running, and climbing stairs. It is commonly seen in the general population. The current literature highlights the tendency of patellofemoral pain to recur and become chronic despite all treatments. Individuals with patellofemoral pain often experience disorders in the neuromuscular function of the quadriceps femoris muscle, which is necessary for knee function and dynamic stability and is frequently suggested to play an important role in the pathophysiology of the disease. A decrease in the tissue's ability to utilize oxygen during exercise or physical activity may lead to permanent dysfunction of the quadriceps femoris muscle. However, no studies have been found in the literature examining changes in oxygenation of the quadriceps femoris muscle in individuals with patellofemoral pain. Therefore, the aim of this study is to investigate changes in oxygenation of the quadriceps femoris muscle in individuals with patellofemoral pain during various exercises and physical activities by comparing them with pain-free individuals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Twenty-one patients with patellofemoral pain and 20 pain-free controls will be conducted at Ankara Medipol University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years of age\n* pain around or behind the patella, which is aggravated by at least one activity that loads the patellofemoral joint during weight bearing on a flexed knee (e.g., squatting, stair ambulation, jogging/running, hopping/jumping)\n* the pain persist for at least four months, and be rated at ≥ 3/10 on the Numeric Pain Rating Scale (NPRS)\n* vastus medialis muscle adipose tissue thickness \\<20 mm\n\nPain-free controls were age- and gender-matched, with vastus medialis muscle adipose tissue thickness \\<20 mm.\n\nExclusion Criteria:\n\n* a history of joint surgery\n* meniscal and/or ligament injuries\n* patellar instability, congenital patellar subluxation/dislocation\n* any cardiovascular, congenital, or musculoskeletal disorders that could interfere with the assessment'}, 'identificationModule': {'nctId': 'NCT07139158', 'briefTitle': 'Muscle Oxygenation in Patellofemoral Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Medipol University'}, 'officialTitle': 'Quadriceps Muscle Oxygenation During Different Lower Limb Tasks in Patients With Patellofemoral Pain: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'GaziU-FTR-SS-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patellofemoral Pain Group'}, {'label': 'Pain-free Control Group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Altındağ', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Selcan Suicmez, Research Asst.', 'role': 'CONTACT', 'email': 'selcansuicmez@hotmail.com', 'phone': '+90 312 444 20 10', 'phoneExt': '8823'}, {'name': 'Cansu Gevrek Aslan, Lecturer', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Serenay Zorlu Develik, Research Asst.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gokhan Yazici, Assoc. Prof.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ankara Medipol University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Selcan Suicmez, Research Asst', 'role': 'CONTACT', 'email': 'selcansuicmez@hotmail.com', 'phone': '+90 312 444 20 10', 'phoneExt': '8823'}, {'name': 'Gokhan Yazici, Assoc. Prof', 'role': 'CONTACT', 'email': 'gokhanyazici38@hotmail.com', 'phone': '+90 312 216 26 01'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Medipol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gazi University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Selcan Suicmez', 'investigatorAffiliation': 'Ankara Medipol University'}}}}