Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-23 @ 9:26 AM
Study NCT ID:
NCT01161758
Status:
COMPLETED
Last Update Posted:
2010-07-14
First Post:
2010-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals
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': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-13', 'studyFirstSubmitDate': '2010-07-08', 'studyFirstSubmitQcDate': '2010-07-13', 'lastUpdatePostDateStruct': {'date': '2010-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electromyography of sternocleidomastoid muscle.', 'timeFrame': 'Pre intervention (baseline) and 1 minute post intervention', 'description': 'Measurement of sternocleidomastoid muscle activation during deep neck flexion. The degree of neck flexion is determined by a pressure biofeedback unit place underneath the neck. EMG of the left and right sternocleidomastoids are recorded for 5seconds at each level of neck flexion'}], 'secondaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': 'Pre intervention (baseline) and 1 minute post intervention', 'description': 'The algometer to measure pressure pain threshold was applied at a constant rate of 40 kPa/sec on the posterior aspect of the left and right articular pillar of C5/C6.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical therapy', 'pain threshold', 'electromyography', 'musculoskeletal manipulation', 'neck muscles'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'Passive accessory cervical mobilization is widely used as a clinical approach to the management of musculoskeletal pain of spinal origin. The purpose of the study is to determine if passive cervical mobilization can improve motor function in situations where motor performance is not impaired by the presence of pain.', 'detailedDescription': 'Cervical mobilization has been shown to elicit effects on pain perception, autonomic function and motor function in subjects who experience musculoskeletal pain. The improvement in motor function may be a direct effect of the treatment or secondary to a hypoalgesic effect. This study aims to demonstrate whether it is possible to alter motor function following joint mobilization, in situations where motor performance is not impaired by pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No history of neck or back pain over the last six months\n* Without any previous experience with spinal manual therapy techniques\n\nExclusion Criteria:\n\n* History of musculoskeletal or rheumatologic conditions\n* Any kind of spinal surgery\n* Dizziness\n* Previous trauma to the cervical spine\n* Neurological signs or symptoms'}, 'identificationModule': {'nctId': 'NCT01161758', 'briefTitle': 'Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Curtin University'}, 'officialTitle': 'A Crossover Study on the Effect of Cervical Mobilization on Motor Function and Pressure Pain Threshold in Pain Free Individuals', 'orgStudyIdInfo': {'id': 'PT0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Passive cervical mobilisation', 'description': 'Grade III cervical mobilization technique as described by Maitland. Applied to left C5/6 Segment.', 'interventionNames': ['Other: Passive cervical mobilisation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Manual contact', 'description': 'Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique.', 'interventionNames': ['Other: Manual contact']}, {'type': 'NO_INTERVENTION', 'label': 'Non-contact control', 'description': 'Non-contact control, which involved the subject resting in the treatment position without any physical contact between the researcher and the subject.'}], 'interventions': [{'name': 'Passive cervical mobilisation', 'type': 'OTHER', 'otherNames': ['Physiotherapy'], 'description': 'Passive cervical mobilization which involved an oscillatory grade III unilateral postero-anterior mobilization applied to the left C5/C6 segment. The mobilization consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.', 'armGroupLabels': ['Passive cervical mobilisation']}, {'name': 'Manual contact', 'type': 'OTHER', 'otherNames': ['placebo light touch'], 'description': 'Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique. The light manual contact consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.', 'armGroupLabels': ['Manual contact']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Benjamin Soon Tze Chin, MManipTher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Queensland'}, {'name': 'Annina Schmid, MManipTher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Queensland'}, {'name': 'Elias Fridriksson, MManipTher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Curtin University'}, {'name': 'Philip Cheong, MManipTher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Curtin University'}, {'name': 'Elisabeth Gresslos, MManipTher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Curitn University of Technology'}, {'name': 'Anthony Wright, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Curtin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Curtin University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Anthony Wright', 'oldOrganization': 'Curtin University of Technology'}}}}