Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT04001218
Status:
COMPLETED
Last Update Posted:
2019-06-28
First Post:
2019-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Head Repositioning Accuracy During Experimental Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'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', 'interventionModelDescription': 'Participants will be randomized to either the painful condition or the control condition first before crossing over to opposite condition.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2015-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-27', 'studyFirstSubmitDate': '2019-06-26', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in head repositioning accuracy', 'timeFrame': 'Within session (session lasts approximately 2 hours)', 'description': 'Participants will be blindfolded and asked asked to, from a neutral position, to move the head into full range of motion before returning to to a neutral position again. The difference between the start and end position will be used as an estimate of head repositioning error.'}], 'secondaryOutcomes': [{'measure': 'Change in perceived pain', 'timeFrame': 'Within session (session lasts approximately 2 hours)', 'description': 'Pain will be scored using a scale from 0-10 with 0 being no pain and 10 being worst imaginable pain, by drawing on body charts and choosing words from the McGill Pain Questionnaire.'}, {'measure': 'Change in perceived performance of head repositioning accuracy test', 'timeFrame': 'Within session (session lasts approximately 2 hours)', 'description': 'Likert scores of the perceived difficultness (0=no problems, 1=minimally difficult, 2=somewhat difficult, 3=fairly difficult, 4= very difficult, 5=unable to perform)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Neck Pain']}, 'descriptionModule': {'briefSummary': 'This study investigates if/how an experimentally applied neck muscle pain influences head repositioning error in healthy participants.', 'detailedDescription': 'Healthy volunteers will participate in a single session study with a crossover design.\n\nDuring the study healthy participants will be randomized to either receive a injection of hypertonic saline (painful injection) or isotonic saline (control injection) in a neck muscle.\n\nHead repositioning accuracy will be assessed with and without performing a cognitive task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women aged 18-50 years\n* Right handed\n* Able to speak, read and understand Danish or English\n* Normal pain free neck and shoulder range of motion\n\nExclusion Criteria:\n\n* Pain from the neck or shoulder area\n* Prior surgery in neck or shoulder\n* Pregnancy\n* Drug addiction defined as the use of cannabis, opioids or other drugs\n* Self reported neurologic, musculoskeletal or mental illnesses'}, 'identificationModule': {'nctId': 'NCT04001218', 'briefTitle': 'Head Repositioning Accuracy During Experimental Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'Neck Pain - Motor and Sensory Aspects', 'orgStudyIdInfo': {'id': 'N20120018_Subproject 1d'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Painful condition', 'description': 'Participants will be injected with 0.5ml hypertonic saline (5.8%) into a neck muscle', 'interventionNames': ['Drug: Injection of hypertonic saline']}, {'type': 'EXPERIMENTAL', 'label': 'Control condition', 'description': 'Participants will be injected with 0.5ml Isotonic saline (0.9%) into a neck muscle', 'interventionNames': ['Drug: Injection of Isotonic saline']}], 'interventions': [{'name': 'Injection of hypertonic saline', 'type': 'DRUG', 'otherNames': ['Hypertonic saline (5.8%)'], 'description': 'Painful condition: Participants will be injected in a neck muscle with 0.5ml of hypertonic saline (5.8%)', 'armGroupLabels': ['Painful condition']}, {'name': 'Injection of Isotonic saline', 'type': 'DRUG', 'otherNames': ['Isotonic saline (0.9%)'], 'description': 'Control condition: Participants will be injected in a neck muscle with 0.5ml isotonic saline (0.9%)', 'armGroupLabels': ['Control condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9220', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Dept. Of Health Science and Technology, SMI, Aalborg University', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Steffan W Christensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Steffan Wittrup Christensen', 'investigatorAffiliation': 'Aalborg University'}}}}