Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
Study NCT ID:
NCT06156605
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2023-11-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2023-11-25', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain pressure threshold', 'timeFrame': 'Baseline, Immediately after, 30 minutes after', 'description': 'PPT at the right PSIS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spine Injury', 'Pain']}, 'referencesModule': {'references': [{'pmid': '38811985', 'type': 'DERIVED', 'citation': 'Schumacher MR, Swanson C, Wolff S, Orteza R, Aguilar R. Exploring the immediate and short-term effect of lumbar spinal manipulation on pressure pain threshold: a randomized controlled trial of healthy participants. Chiropr Man Therap. 2024 May 29;32(1):19. doi: 10.1186/s12998-024-00540-5.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test in the effects of pain pressure threshold (PPT) looking out to 30 minutes in the lumbar spine. The main question\\[s\\] it aims to answer are:\n\n• Is there a difference between PPT from baseline, immediately after, or 30 minutes after compared to sham ultrasound control group? Participants will be exposed to sham ultrasound or sidelying lumbar manipulation with between groups and within group comparisons of PPT at the posterior superior iliac spine up to 30 minutes following the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic individuals between the ages of 18-50\n\nExclusion Criteria:\n\n* Current low back pain (LBP)\n* A history of low back pain LBP within the last three months\n* Previous spinal surgery\n* Rheumatological condition or neurological symptoms or conditions\n* Recent ingestion of pain-relieving medications within the last 24 hours\n* A lumbar manipulation within three days prior to the exam\n* Exhibited any contraindications to manipulation\n* Positive findings during screening precautions'}, 'identificationModule': {'nctId': 'NCT06156605', 'acronym': 'LumbarPPTUMary', 'briefTitle': 'Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals', 'organization': {'class': 'OTHER', 'fullName': 'University of Mary'}, 'officialTitle': 'Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals', 'orgStudyIdInfo': {'id': 'UMary1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sidelying lumbar manipulation', 'description': 'Right sided lumbar manipulation', 'interventionNames': ['Procedure: Sidelying lumbar manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham ultrasound', 'description': 'Sham (non-therapeutic settings) ultrasound at the right PSIS', 'interventionNames': ['Procedure: Sidelying lumbar manipulation']}], 'interventions': [{'name': 'Sidelying lumbar manipulation', 'type': 'PROCEDURE', 'description': 'R sided lumbar manipulation', 'armGroupLabels': ['Sham ultrasound', 'Sidelying lumbar manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58503', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'University of Mary', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Schumacher, PT, DPT, OCS, FAAOMPT', 'investigatorFullName': 'Matthew Schumacher', 'investigatorAffiliation': 'University of Mary'}}}}