Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
Study NCT ID:
NCT06712992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2024-11-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electromyographic Response to TsDcs in CNSLBP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-30', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in NPRS from baseline to four weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': "An 11-point Numerical Pain Rating Scale (NPRS; 0= no pain, 10= maximum pain) will be used to assess the patients' pre and post treatment levels of back pain. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. Scores range from 0-10 points, with higher scores indicating greater pain intensity"}], 'secondaryOutcomes': [{'measure': 'Changes in Nociceptive Flexion Reflex (NFR) Threshold and area from baseline to 4 weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The NFR threshold will be assessed as an objective measure of spinal nociceptive processing in adults with chronic non-specific low back pain (CNSLBP). The NFR threshold will be defined as the lowest stimulus intensity that elicits an NFR response.The NFR threshold and NFR area will be assessed before and after 4 weeks of trans-spinal direct current stimulation (tsDCS) plus exercise or sham stimulation plus exercise.'}, {'measure': 'Changes in PROMIS Global Health - 10 Survey from baseline to 4 weeks', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) is a comprehensive instrument designed to assess health-related quality of life across various domains. PROMIS GH-10, specifically, is tailored to measure global physical and mental health. It encompasses a range of items that evaluate general health perceptions, physical function, pain, fatigue, emotional distress, and social health. PROMIS GH-10 has been demonstrated to be reliable and valid for use in the general population and various specific conditions, such as low back pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized, double-blinded, sham-controlled study is to investigate the efficacy of trans-spinal direct current stimulation on pain level, quality of life, and electromyographic nociceptive flexion reflex in patients with non-specific chronic low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals of both sexes.\n* Age 18-60 years old.\n* Chronic non-specific low back pain according to the most recent guidelines for the diagnosis and management of NSLPB come from the American College of Physicians and was published in 2017. According to these guidelines, the diagnosis of chronic NSLBP should be made based on the following criteria:\n* Chronic low back pain, defined as pain lasting for more than 12 weeks.\n* No specific identifiable cause of pain(e.g. infection, malignancy, fracture, inflammatory disorder).\n* No radicular symptoms(e.g. pain radiating down the leg).\n* No significant neurological deficits or findings on physical examination(e.g. loss of reflexes or muscle strength).\n\nExclusion Criteria:\n\n* Previous fractures and/or surgery in the vertebral spine.\n* Neuropathic pain extending along the lower limb due to nerve root compression.\n* History of spine trauma or fracture.\n* Implanted pacemakers.\n* Pregnancy.\n* Malignancy.\n* Systemic musculoskeletal diseases.\n* Epilepsy.\n* History of psychiatric disorders.\n* Obesity'}, 'identificationModule': {'nctId': 'NCT06712992', 'briefTitle': 'Electromyographic Response to TsDcs in CNSLBP', 'organization': {'class': 'OTHER', 'fullName': 'German International University'}, 'officialTitle': 'Effect of Trans-Spinal Direct Current Stimulation in the Management of Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T/REC/2024.10021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trans-spinal direct current stimulation group', 'description': 'Patients in this group will receive Conventional Exercises in addition to tsDCS. We will apply a current density of 0.035 mA/cm2 and will deliver a total charge density of 42.8 mC/cm2, below the threshold values reported for tissue damage. For tsDcs, At the onset of tsDCS, the current will be increased for 30 s, and at the offset, it will be decreased for 30 s in a ramp-like manner. Participants will receive three sessions of treatment per week for four weeks, with a total of twelve sessions.', 'interventionNames': ['Device: Trans-spinal Direct Current Stimulation', 'Other: Conventional Exercises']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Trans-spinal direct current stimulation group', 'description': 'Patients in this group will receive Conventional Exercises in addition to SHAM tsDCS. For a sham tsDCS, the current will be ramped up for 30 seconds turned on for 5 s and then turned off in a ramp shaped fashion, thus inducing skin sensations indistinguishable from anodal tsDCS. This method was shown to achieve a good level of blinding among sessions. Participants will receive three sessions of treatment per week for four weeks, with a total of twelve sessions.', 'interventionNames': ['Other: Conventional Exercises', 'Drug: SHAM Trans-spinal Direct current stimulation']}], 'interventions': [{'name': 'Trans-spinal Direct Current Stimulation', 'type': 'DEVICE', 'description': 'Physiomed- IONOSON-Expert, Germany will be used to deliver SHAM direct current, The Physiomed- IONOSON-Expert, Germany is Two-channel electrotherapy including 21 currents, including direct current. The tsDCS electrodes will be rectangular pieces of saline-soaked synthetic sponge (7 × 8 cm, 56 cm2), to minimize chemical reactions at the electrode-skin interface. The anode will be placed over the spinous process of the eighth thoracic vertebra (T8) and the cathode will be placed on the second lumbar vertebra (L2) according to a modeling study which demonstrated that this configuration had a relevant impact on the distribution of the induced electric field (EF) in the lumbosacral spinal cord for the efficacy of tsDCS.', 'armGroupLabels': ['Trans-spinal direct current stimulation group']}, {'name': 'Conventional Exercises', 'type': 'OTHER', 'description': '1. Isometric exercises of spine\n\n * Hollowing in abdominals.\n * Isometric for back extensors.\n2. Bridging exercises.\n3. Graded active flexion exercises of spine\n4. Graded active extension exercises of spine', 'armGroupLabels': ['Sham Trans-spinal direct current stimulation group', 'Trans-spinal direct current stimulation group']}, {'name': 'SHAM Trans-spinal Direct current stimulation', 'type': 'DRUG', 'description': 'For a sham tsDCS, the current will be ramped up for 30 seconds turned on for 5 s and then turned off in a ramp shaped fashion, thus inducing skin sensations indistinguishable from anodal tsDCS. This method was shown to achieve a good level of blinding among sessions.\n\nThese parameters for sham stimulation were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade usually out in the first 30 s of TsDcs .', 'armGroupLabels': ['Sham Trans-spinal direct current stimulation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12611', 'city': 'Sixth of October', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Outpatient clinic of faculty of physical therapy, Ahram Canadian University'}, {'zip': '12611', 'city': 'Sixth of October', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Outpatient clinical of faculty of physical therapy, Ahram Canadian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal invistigator', 'investigatorFullName': 'Ahmed Medhat Mahfouz Elgamal', 'investigatorAffiliation': 'Cairo University'}}}}