Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT05937503
Status:
UNKNOWN
Last Update Posted:
2023-07-18
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant will not informed about the intervention'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-15', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Up to one month', 'description': 'A 10 cm Visual Analog Scale will be used to determine the severity of pain, with numbers ranging from "0" (no pain) to "10" (unbearable pain)'}, {'measure': 'Central Sensitization', 'timeFrame': 'Up to one month', 'description': 'Central Sensitization Inventory (CSI) scale will be used severity of central sensitization.The total score range of the scale, which consists of a total of 25 questions, is between 0-100 points. Central sensitization with a score of 40 and above is considered positive. An increase in the total score indicates an increase in the level of central sensitization.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index', 'timeFrame': 'Up to one month', 'description': 'Oswestry Disability Index (ODI) will be used to measure disability level'}, {'measure': 'Health Survey', 'timeFrame': 'Up to one month', 'description': '36-item Short Form Health Survey Questionnaire (SF-36) will be used'}, {'measure': 'Hospital Anxeity and depresssion', 'timeFrame': 'Up to one month', 'description': 'Hospital Anxeity and Depression Scale will be used. The cut-off points for caseness of anxiety or depression is 8/21 for anxiety or depression. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83.\n\nThe scores of the scale are as follows: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['central sensitization', 'manual therapy', 'non-specific low back pain'], 'conditions': ['Central Sensitization', 'Manual Therapy']}, 'descriptionModule': {'briefSummary': 'Central sensitization (CS) is defined as the increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input. CS has been proposed as an underlying mechanism of chronic pain in musculoskeletal disorders including low back pain (LBP).\n\nThe aim of this study is to investigate the effect of manual therapy on central sensitization in patients with nonspecific chronic LBP.', 'detailedDescription': 'A total of 40 LBP patients aged between 24-64 with CSS will be randomized into two groups. The manual therapy group will receive a 4-week manual therapy (two sessions/week) plus the conventional physiotherapy program, while the control group will only receive conventional physiotherapy. Before and after the interventions pain intensity (VAS), and scores of three questionnaires: Oswestry Disability Index (ODI), Central Sensitization Inventory (CSI), and the 36-item Short Form Health Survey Questionnaire (SF-36) will be recorded.The outcomes of the study will be analyzed by appropriate statistical methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-spesific low back pain patients with pain longer than 12 weeks\n* aged between 20-64 years male and female participants\n\nExclusion Criteria:\n\n* concomitant disease that would interfere with treatment\n* pregnancy\n* have had any spinal surgery or fracture'}, 'identificationModule': {'nctId': 'NCT05937503', 'briefTitle': 'Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Atılım University'}, 'officialTitle': 'Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain.A Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'E-59394181-604.01.02-33380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manual therapy', 'description': 'Manual therapy group', 'interventionNames': ['Other: manual therapy', 'Other: conventional physiotherapy']}, {'type': 'OTHER', 'label': 'Conventional physiotherapy', 'description': 'Conventional physiotherapy group', 'interventionNames': ['Other: manual therapy', 'Other: conventional physiotherapy']}], 'interventions': [{'name': 'manual therapy', 'type': 'OTHER', 'otherNames': ['conventional physiotherapy'], 'description': 'The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.', 'armGroupLabels': ['Conventional physiotherapy', 'Manual therapy']}, {'name': 'conventional physiotherapy', 'type': 'OTHER', 'description': 'Control group will only receive conventionel physiotherapy intervention.', 'armGroupLabels': ['Conventional physiotherapy', 'Manual therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06830', 'city': 'Ankara', 'state': 'Select State', 'country': 'Turkey (Türkiye)', 'facility': 'Naime Ulug', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Atılım University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atılım University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD.', 'investigatorFullName': 'NAİME ULUG', 'investigatorAffiliation': 'Atılım University'}}}}