Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT05582733
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2022-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Cervical Spine Manipulation
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': 'D014143', 'term': 'Traction'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Free envelop method'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes from the baseline in Algometer values', 'timeFrame': 'Baseline and 3 weeks', 'description': 'It is a device used to identify the pressure and force eliciting a pressure pain threshold. The hand held algometer 1 cm round rubber surface which applies force and display for readings in newtons or kilograms.Sustained force is usually applied at the right angle to the soft tissue. Estimated pressure application rates have ranged from 0.05 to 20N/s. it has a high validity and reliability for measuring pain pressure threshold in patients of myofascial trigger points.'}, {'measure': 'changes from the baseline in Inclinometer values', 'timeFrame': 'Baseline and 3 weeks', 'description': 'It is a device used to measure neck ranges of motion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Pain']}, 'descriptionModule': {'briefSummary': 'To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point. it was a randomized control trial including 66 patients at physiotherapy OPD of railway rehabilitation center from August 2019 to December 2019, Railway General Hospital Pakistan and Max Rehab and decompression center Max health Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method.', 'detailedDescription': 'To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point and neck ranges of motion. A randomized control trial of 66 patients was conducted from August 2019 to December 2019 at physiotherapy OPD of railway rehabilitation center, Railway General Hospital Pakistan and Max Rehab and decompression center Maxhealth Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method. Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching. Structural questionnaire was used for pre and post assessment. Outcomes were measured by algometry and inclinometer before and after the application of respective techniques. The data was analyzed at baseline and immediately after the intervention on IBM SPSS-21.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.presence MTrps in upper trapezius\n* limited side bending and rotation\n* both gender\n* age between 25 to 45\n\nExclusion Criteria:\n\n* Malignancy, infection, trauma, bone deformities.\n* Acute Disc Protrusion\n* Positive VBI\n* Positive Sharp purser test\n* History of whiplash injury'}, 'identificationModule': {'nctId': 'NCT05582733', 'briefTitle': 'Effects of Cervical Spine Manipulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Effects of Cervical Spine Manipulation on Upper Trapezius Active Versus Conventional Techniques.', 'orgStudyIdInfo': {'id': 'REC:00570'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical spine manipulation', 'description': 'In spinal manipulation, the velocity, magnitude and direction of the impulse are controlled to encourage relaxation and comfort of muscle and connective tissue.', 'interventionNames': ['Other: Cervical spine manipulation', 'Other: traction']}, {'type': 'EXPERIMENTAL', 'label': 'traction', 'description': 'aimed to relieve pressure on the spine', 'interventionNames': ['Other: Cervical spine manipulation', 'Other: traction']}], 'interventions': [{'name': 'Cervical spine manipulation', 'type': 'OTHER', 'description': 'hot pack for 10 minutes will be applied followed by cervical manipulation (chin hold kaltenborn) once and then stretching', 'armGroupLabels': ['Cervical spine manipulation', 'traction']}, {'name': 'traction', 'type': 'OTHER', 'description': 'Hot pack will be applied followed by sustained pressure or MPR for 90 sec and then stretching.', 'armGroupLabels': ['Cervical spine manipulation', 'traction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00430', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Dr. Abdul Gaffoor', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Abdul Ghafoor Sajjad, PHD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ghafoor.sajjad@riphah.edu.pk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Riphah International University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Madeeha Shafiq', 'investigatorAffiliation': 'University of Lahore'}}}}