Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT06330402
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2024-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploration of Gait Biomechanics and Pain
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain intensity (NRS 0-10)', 'timeFrame': 'Baseline', 'description': "Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imagineable'"}, {'measure': 'Pain distribution', 'timeFrame': 'Baseline', 'description': 'Pain during intervention is marked on a body chart'}], 'primaryOutcomes': [{'measure': 'Infrared marker XYZ coordinates', 'timeFrame': 'Baseline', 'description': 'Marker-based motion capture with infrared cameras will be used to estimate placement of reflective markers in the XYZ planes measured in milimeters. Reflective markers will be placed from head-to-toe on anatomical landmarks.'}, {'measure': 'Pain sensitivity.', 'timeFrame': 'Baseline', 'description': 'Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation.'}], 'secondaryOutcomes': [{'measure': 'The Pittsburgh Sleep Quality Index score', 'timeFrame': 'Baseline', 'description': '19 items summarized to a single score ranging from zero to 21 with higher scores reflecting worse quality of sleep.'}, {'measure': 'The Pain catastrophizing Scale score', 'timeFrame': 'Baseline', 'description': '13 items summarized to a single score ranging from zero to 52 with higher scores reflecting more catastrophizing.'}, {'measure': 'The Hospital Anxiety and Depression Scale', 'timeFrame': 'Baseline', 'description': '14 items summarized into two 7-item subscales measuring symptoms of anxiety and depression. Each subscale score ranges from zero to 21 with higher scores reflecting more severe symptoms.'}, {'measure': 'Knee symptoms', 'timeFrame': 'Baseline', 'description': '42 items divided into five subscales: pain (9 items), activities of daily living (17 items), sport and recreation function (5 items), knee-related quality of life (4 items), and other symptoms (7 items). Each subscale is score from zero to 100 with higher scores reflecting increased severity of knee problems.'}, {'measure': 'Ground reaction forces', 'timeFrame': 'Baseline', 'description': 'Ground reaction forces will be measured in Newton-meters with force plates embedded in the floor.'}, {'measure': 'Ground reaction moments', 'timeFrame': 'Baseline', 'description': 'Ground reaction moments will be measured in Newton-meters with force plates embedded in the floor.'}, {'measure': 'Ground contact XZ location', 'timeFrame': 'Baseline', 'description': 'Ground contact XZ coordinate location will be measured in milimeters with force plates embedded in the floor.'}, {'measure': 'Muscle activation', 'timeFrame': 'Baseline', 'description': 'Muscle activation will be measured in micro-volts using wireless EMG on the muscles of the lower extremities.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Healthy']}, 'descriptionModule': {'briefSummary': 'This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:\n\n* How do gait patterns change during painful walking?\n* Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?\n\nParticipants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition).', 'detailedDescription': 'This study will be a randomized, crossover design where experimental knee pain will be provoked in healthy subjects using hypertonic saline injections to the infrapatellar fat pad (IFP). This will be controlled with a second injection of isotonic saline, which is non-painful. The participants will not be informed of the type of injection.\n\nHypertonic saline injections to the IFP usually provoke pain lasting about 15 minutes. Within this timeframe, motion capture will be conducted to estimate the biomechanics of gait. During the motion capture the participants will perform five 10-meter walking trials and three jumps. This process will be replicated for the control condition.\n\nAdditionally, the participants will have their pain sensitivity tested using cuff-pressure algometry before both IFP injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women aged 18-45 years\n\nExclusion Criteria:\n\n* Pregnancy\n* Drug addiction, defined as the use of cannabis, opioids, or other drugs\n* Previous or current neurologic or musculoskeletal illnesses\n* Current pain\n* Lack of ability to cooperate'}, 'identificationModule': {'nctId': 'NCT06330402', 'briefTitle': 'Exploration of Gait Biomechanics and Pain', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'Undersøgelse af sammenhængen Mellem Biomekanik og Smerter Ved Gang', 'orgStudyIdInfo': {'id': 'N-20220063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Painful condition', 'description': 'Hypertonic saline injection to the infrapatellar fat pad.', 'interventionNames': ['Other: Hypertonic saline injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control condition', 'description': 'Isotonic saline injection to the infrapatellar fat pad.', 'interventionNames': ['Other: Isotonic saline injection']}], 'interventions': [{'name': 'Hypertonic saline injection', 'type': 'OTHER', 'description': '0.25 mL injection with hypertonic saline (7%) to the infrapatellar fat pad.', 'armGroupLabels': ['Painful condition']}, {'name': 'Isotonic saline injection', 'type': 'OTHER', 'description': 'Control injection with 0.25 mL isotonic saline (0.9%) to the infrapatellar fat pad.', 'armGroupLabels': ['Control condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'state': 'North Denmark', 'country': 'Denmark', 'facility': 'Aalborg University', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kristian Kjær Petersen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kristian Kjær Petersen', 'investigatorAffiliation': 'Aalborg University'}}}}