Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-05 @ 6:17 PM
Study NCT ID:
NCT03976232
Status:
UNKNOWN
Last Update Posted:
2019-06-05
First Post:
2019-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-04', 'studyFirstSubmitDate': '2019-05-27', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polysomnography', 'timeFrame': 'changes between baseline to 2 weeks and 6 weeks', 'description': 'Polysomnographic parameters will be recorded.'}, {'measure': 'Pittsburgh sleep quality Index scale.', 'timeFrame': 'changes between baseline to 2 weeks and 6 weeks', 'description': 'Qualitative assessment of sleep will be recorded by this scale'}], 'secondaryOutcomes': [{'measure': 'Modified Oswestry disability index', 'timeFrame': 'changes between baseline to 2 weeks and 6 weeks', 'description': 'Chronic low back pain-related disability will be recorded'}, {'measure': 'NPRS', 'timeFrame': 'changes between baseline to 2 weeks and 6 weeks', 'description': 'Pain intensity will be recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disturbance', 'Chronic Low-back Pain']}, 'descriptionModule': {'briefSummary': 'Sleep problems in patients with CLBP are a very common complication and is the most neglected part of the management. Though previous literature suggested that sleep problems need to be managed in patients with CLBP, no physical therapy or manual therapy techniques has been checked for their efficacy to manage the same. Therefore, there is a need to check the efficacy of various physical therapy and manual therapy techniques so that sleep problems associated with CLBP can be managed effectively by physical means. The main purpose of the study is to check the efficacy of tDCS and CST to improve sleep, pain and quality of life in patients with CLBP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. People with chronic low back pain (more than 3 months)\n2. Both males and females.\n3. 18-50 years\n4. Able to follow verbal commands.\n\nExclusion Criteria:\n\n1. Diagnosed with primary sleep disorders\n2. Pregnancy\n3. Taking any medication for a psychological disorder\n4. Acute or subacute LBP\n5. Diagnosed with any other systemic disorder.\n6. Spinal tumour.\n7. Radicular pain and nerve root compression.\n8. Severe spinal stenosis, spondylolisthesis, fibromyalgia.\n9. Unstable angina and other cardiovascular disorders.\n10. Malignancy.\n11. History of other systemic and inflammatory disease.'}, 'identificationModule': {'nctId': 'NCT03976232', 'briefTitle': 'Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi Markendeswar University (Deemed to be University)'}, 'officialTitle': 'Efficacy of Trans Cranial Direct Current Stimulation (tDCS) Along With Craniosacral Therapy (CST) on Sleep Disturbances in Patients With Chronic Low Back Pain (CLBP)', 'orgStudyIdInfo': {'id': 'IEC-1361'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS-Group', 'description': 'Participants of this arm will receive tDCS and Conventional therapy for 2 weeks.', 'interventionNames': ['Device: Trans cranial Direct Current Stimulation (tDCS)']}, {'type': 'EXPERIMENTAL', 'label': 'CST- Group', 'description': 'Participants of this arm will receive CST and Conventional therapy for 2 weeks.', 'interventionNames': ['Other: Craniosacral therapy (CST)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'combination of tDCS and CST', 'description': 'Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks.', 'interventionNames': ['Other: tDCS+ CST']}], 'interventions': [{'name': 'Trans cranial Direct Current Stimulation (tDCS)', 'type': 'DEVICE', 'description': 'Active tDCS will be applied for 20 minutes with 2 mA intensity. Anode will be placed at left dorsolateral prefrontal cortex and cathode will be placed at the right cerebellar cortex.', 'armGroupLabels': ['tDCS-Group']}, {'name': 'Craniosacral therapy (CST)', 'type': 'OTHER', 'description': 'Craniosacral therapy will be given to all the participants which includes release of all major diaphragm, frontal lift, parietal lift, occipital lift, CV4 and dural tube rocking.', 'armGroupLabels': ['CST- Group']}, {'name': 'tDCS+ CST', 'type': 'OTHER', 'description': 'This group will receive tDCS along with CST', 'armGroupLabels': ['combination of tDCS and CST']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Subhasish Chatterjee, MPT', 'role': 'CONTACT', 'email': 'subhasishphysio@gmail.com', 'phone': '8708660994'}, {'name': 'Vandana Esht, Ph.D', 'role': 'CONTACT', 'phone': '8059930235'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharishi Markendeswar University (Deemed to be University)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Subhasish Chatterjee', 'investigatorFullName': 'Subhasish Chatterjee', 'investigatorAffiliation': 'Maharishi Markendeswar University (Deemed to be University)'}}}}