Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-02 @ 6:26 AM
Study NCT ID:
NCT03992495
Status:
UNKNOWN
Last Update Posted:
2019-06-20
First Post:
2019-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Exercise on Pain Sensitivity in a Population With Ongoing Neck Pain Compared to Healthy Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-19', 'studyFirstSubmitDate': '2019-06-18', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in body movements', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Head repositioning accuracy will be tested using a clinical test in a seated position. Participants will turn their head to end of range in from a neutral position with their eyes closed and return to the start position again. The difference between start and end position will be recorded. Standing balance will be assessed by recording the time (seconds) a tandem stance can be maintained.'}], 'primaryOutcomes': [{'measure': 'Change in pain sensitivity', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Pain sensitivity will be estimated by determining the pressure pain threshold (PPT) on the neck before and after exercise'}], 'secondaryOutcomes': [{'measure': 'Change in perceived pain', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Pain will be scored using a scale from 0-10 with 0 being no pain and 10 being worst imaginable pain and by drawing perceived painful areas on a body charts'}, {'measure': 'Change in disability', 'timeFrame': 'Baseline, 6 weeks, 12 weeks', 'description': 'Disability will be estimated by scoring the Neck Disability Index (NDI) questionnaire. The questionnaire is designed to help express how neck pain affects your ability to manage everyday activities.(Domains: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, recreation). Higher score = high level of disability'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Neck pain', 'Pain sensitivity'], 'conditions': ['Neck Pain', 'Healthy']}, 'descriptionModule': {'briefSummary': 'This study investigates the effect of exercise on pain sensitivity in ongoing neck pain patients compared to a healthy control group.', 'detailedDescription': 'Increased pain sensitivity is a common finding in neck pain patients when compared to healthy controls. Although most studies favor exercise as an intervention, the specific effect on pain sensitivity is still debated. This study will investigate the effect of exercise on pain sensitivity in neck pain patients compared to healthy controls'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with self-reported pain from the neck area with a symptom duration of three months or longer and pain free healthy participants.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: - Healthy participants\n\n* Pain free healthy participants\n* Able to speak, read and understand Danish and English\n\nExclusion Criteria: - Healthy participants\n\n* Pain from the neck or shoulder area during the past 6 months\n* Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session\n* Former surgery in neck or shoulder\n* Current or previous chronic or recurrent pain condition\n* Pregnancy\n* Drug addiction defined as the use of cannabis, opioids or other drugs\n* Previous neurologic, musculoskeletal or mental illnesses\n* Regular use of analgesics\n* Abnormally disrupted sleep in the last 24 hours preceding the experiment\n* Lack of ability to cooperate\n\nInclusion Criteria: - Neck pain population\n\n* Self reported neck pain lasting three months or longer.\n* Able to speak, read and understand Danish and English\n* Reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion\n\nExclusion Criteria: - Neck pain population\n\n* Shoulder pain during arm movements\n* Experience of DOMS during the week leading up to the test session\n* Former surgery in neck or shoulder\n* Current or previous chronic or recurrent pain condition other than neck pain\n* Pregnancy\n* Drug addiction defined as the use of cannabis, opioids or other drugs\n* Previous neurologic, musculoskeletal or mental illnesses\n* Abnormally disrupted sleep in the 24 hours preceding the experiment\n* Lack of ability to cooperate'}, 'identificationModule': {'nctId': 'NCT03992495', 'briefTitle': 'The Effect of Exercise on Pain Sensitivity in a Population With Ongoing Neck Pain Compared to Healthy Controls', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'The Effect of Exercise on Neck Pain and Pain Sensitivity', 'orgStudyIdInfo': {'id': 'N-20180063_Sub-project_3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neck pain', 'description': 'People suffering from neck pain at the time of recruitment', 'interventionNames': ['Other: Exercise']}, {'label': 'Healthy', 'description': 'Participants with no significant past neck pain, chronic pain or other relevant medical disorders.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'All participants will be exposed to aerobic/strengthening exercises', 'armGroupLabels': ['Healthy', 'Neck pain']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Steffan W Christensen, PhD', 'role': 'CONTACT', 'email': 'stc@hst.aau.dk', 'phone': '99408889', 'phoneExt': '+45'}], 'overallOfficials': [{'name': 'Steffan W Christensen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Steffan Wittrup Christensen', 'investigatorAffiliation': 'Aalborg University'}}}}