Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT03507920
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2018-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-02', 'studyFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global rating of change scale', 'timeFrame': 'Immediately after the intervention', 'description': 'Measures overall improvement as perceived by the participant. It is a 15-point scale ranging from -7 (a very great deal worse), through 0 (no change), to +7 (a great deal better). Values above 0 denote improvement following treatment, 0 denotes no change, and values below 0 denote worsening after the treatment. The higher the value, the greater the improvement; the lower the value, the greater the worsening. The participant will be asked to provide a value that represents their change (they may give 0, which denotes no change) following the intervention.'}, {'measure': 'Change in pain reported by the participant during neck movements', 'timeFrame': 'Baseline and immediately after the intervention', 'description': 'The participant will be asked to report if he/she has pain on each of the following movements: flexion, extension, side flexion and rotation'}, {'measure': 'Change in Sympathetic nervous system activity using skin conductance', 'timeFrame': 'Baseline, during the intervention and immediately after the intervention', 'description': 'Skin conductance in the index and ring finger will be measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of spinal mobilizations on neck symptoms and sympathetic nervous system activity in people with neck pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary complaint of neck pain\n* Non-traumatic history of onset\n* Pain has a clear mechanical aggravating and easing positions or movements\n* Limited range of motion\n* Local provocation tests produce recognisable symptoms\n* A positive expectation that mobilisations will help\n\nExclusion Criteria:\n\n* No neurological deficit\n* No signs of central hyperexcitability\n* Referral to other health professional to exclude red flags not required'}, 'identificationModule': {'nctId': 'NCT03507920', 'briefTitle': 'The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain', 'orgStudyIdInfo': {'id': 'M10/2016/095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neck passive mobilizations', 'interventionNames': ['Other: Neck passive mobilizations']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Manual contact', 'interventionNames': ['Other: Manual contact']}], 'interventions': [{'name': 'Neck passive mobilizations', 'type': 'OTHER', 'description': 'Passive mobilizations performed to the neck of the participant by a Physiotherapist', 'armGroupLabels': ['Neck passive mobilizations']}, {'name': 'Manual contact', 'type': 'OTHER', 'description': 'Manual contact applied to the neck of the participant by a Physiotherapist', 'armGroupLabels': ['Manual contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48940', 'city': 'Leioa', 'state': 'Bizkaia', 'country': 'Spain', 'facility': 'University of the Basque Country, Faculty of Medicine and Infirmary', 'geoPoint': {'lat': 43.32686, 'lon': -2.98884}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of the Basque Country (UPV/EHU)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}