Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-28 @ 6:44 PM
Study NCT ID:
NCT05972395
Status:
UNKNOWN
Last Update Posted:
2023-08-02
First Post:
2023-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conditioned Pain Modulation in Localized vs Widespread Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-24', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conditioned Pain Modulation', 'timeFrame': 'Baseline', 'description': 'Percent change in pressure pain threshold at the lumbar region during cold water hand immersion conditioning stimulus compared to baseline pressure pain threshold at the lumbar region without the conditioning stimulus.'}], 'secondaryOutcomes': [{'measure': 'Pressure Pain Thresholds', 'timeFrame': 'baseline', 'description': 'Pressure pain thresholds measured in kg/cm2 using a pressure algometer at the lumbar spine and distal sites including the upper trapezius and thumbnail.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Low-back Pain']}, 'descriptionModule': {'briefSummary': "This study aims to compare function of the body's endogenous pain modulation system between people with localized low back pain versus widespread body pain. Endogenous pain modulation refers to the body's natural ability to inhibit one pain stimulus by applying a second pain stimulus. This study will assess pain inhibition by measuring pressure pain thresholds at the low back before and during cold water hand immersion. The researchers hypothesize that those with widespread body pain will have worse functioning of pain inhibition compared to those with localized low back pain only. The results may provide insights into personalized chronic pain management approaches.", 'detailedDescription': 'Chronic low back pain (CLBP) is highly prevalent worldwide. Impairments in conditioned pain modulation (CPM) have been documented in CLBP populations. CPM refers to endogenous pain inhibition, where one noxious stimulus inhibits pain from a second noxious stimulus. This relies on descending inhibitory pathways. However, it is unknown whether CPM alterations differ between individuals with localized versus widespread mechanical pain hypersensitivity. The aim of this cross-sectional quantitative sensory testing study is to compare CPM function between localized and widespread CLBP subgroups. A sample of 75 adults with CLBP of at least 3 months duration will be recruited from a chronic pain clinic. Based on pressure pain threshold mapping at the low back and distal sites, participants will be classified as having localized or widespread mechanical hyperalgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with chronic nonspecific LBP stratified by localized vs widespread mechanical hyperalgesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-60 years\n* Chronic LBP \\>3 months\n* Average LBP intensity ≥4/10\n\nExclusion Criteria:\n\n* Known LBP pathologies\n* Previous lumbar surgery\n* Neuropathic LBP\n* Comorbid generalized pain conditions'}, 'identificationModule': {'nctId': 'NCT05972395', 'briefTitle': 'Conditioned Pain Modulation in Localized vs Widespread Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'Determining if Conditioned Pain Modulation Differs Between Individuals With Localized Versus Widespread Mechanical Pain Hypersensitivity in Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'LBP01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Localized CLBP', 'description': 'Chronic low back pain \\>3 months with localized pressure pain hyperalgesia', 'interventionNames': ['Other: Localized vs Widespread Mechanical Pain Hypersensitivity']}, {'label': 'Widespread CLBP', 'description': 'Chronic low back pain \\>3 months with widespread pressure pain hyperalgesia', 'interventionNames': ['Other: Localized vs Widespread Mechanical Pain Hypersensitivity']}], 'interventions': [{'name': 'Localized vs Widespread Mechanical Pain Hypersensitivity', 'type': 'OTHER', 'description': 'Based on pressure pain threshold mapping, participants will be classified as having either localized mechanical pain hyperalgesia (hyperalgesia limited to the lumbosacral region) or widespread mechanical pain hyperalgesia (hyperalgesia extending beyond the lumbosacral region).', 'armGroupLabels': ['Localized CLBP', 'Widespread CLBP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3221405', 'city': 'Al Ḩayy Ath Thāmin', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '01064442032'}], 'facility': 'Outpatient clinic of faculty of physical therapy, Ahram Canadian University'}], 'centralContacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '+201064442032'}], 'overallOfficials': [{'name': 'Amal Fawzy, Ph.d', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Physical Therapy, Ahram Canadian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical Therapy and Director of Electromyography Lab', 'investigatorFullName': 'Mohamed Magdy ElMeligie', 'investigatorAffiliation': 'Ahram Canadian University'}}}}