Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-04 @ 7:10 PM
Study NCT ID:
NCT06569069
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': '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': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Low back pain intensity', 'timeFrame': 'Measurements will be taken before intervention and four weeks after the third session (last session) of treatment', 'description': 'This will be measured using the Visual Analogue Scale (minimum score 0, maximum score 10, higher values means worse pain)'}], 'secondaryOutcomes': [{'measure': 'Neuropathic symptoms', 'timeFrame': 'Measurements will be taken before intervention and four weeks after the third session (last session) of treatment', 'description': 'This will be measured using the Doleur Neuropatique 4 questionnaire (minimum score 0, maximum score 10, higher values means more neuropathic symtoms)'}, {'measure': 'Hamstrings strength', 'timeFrame': 'Measurements will be taken before intervention and four weeks after the third session (last session) of treatment', 'description': 'This will be measured using the manual muscle testing (minimum score 0, maximum score 5, higher values means more strength).'}, {'measure': 'Triceps suralis strength', 'timeFrame': 'Measurements will be taken before intervention and four weeks after the third session (last session) of treatment', 'description': 'This will be measured using the manual muscle testing (minimum score 0, maximum score 5, higher values means more strength).'}, {'measure': 'Posterior Tibialis strength', 'timeFrame': 'Measurements will be taken before intervention and four weeks after the third session (last session) of treatment', 'description': 'This will be measured using the manual muscle testing (minimum score 0, maximum score 5, higher values means more strength).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['disc herniation', 'US guided PE', 'Lumbar pain'], 'conditions': ['Posterolateral Disc Herniation L4-L5-S1', 'Disk Herniated Lumbar']}, 'descriptionModule': {'briefSummary': 'Lumbar discopathies are among the most common medical concerns in Europe and Spain. Globally, around 2-3% of the population is affected by this condition, which manifests as tingling, burning, itching, muscle weakness, limb pain, or allodynia. The most frequent cases involve lumbar disc herniations at the L4-L5 and L5-S1 levels, which typically compress the tibial nerve. This nerve provides motor and sensory innervation to the posterior knee, leg, foot sole, and posterior thigh.\n\nTreatment options for lumbar discopathies range from pharmacological interventions (cytokine inhibitors, analgesics, muscle relaxants, corticosteroids, non-steroidal anti-inflammatory drugs, and vitamin B12), to ozone injections, nerve root blocks, or surgeries like discectomy. However, conservative physiotherapy approaches, such as therapeutic exercise, axial decompression, transcutaneous electrical nerve stimulation, and peripheral electric stimulation, have gained attention for their efficacy in treating lumbar discopathy symptoms.\n\nPhysiotherapy uses electrical currents, applied either directly via needles under ultrasound guidance or non-invasively, to improve the quality of life for individuals with lumbar-origin peripheral nerve involvement. Ultrasound-guided percutaneous electrolysis (US-guided PE) is being explored for its fibrolytic effects in areas of tendon-nerve fibrosis, such as the proximal hamstring tendon and sciatic nerve, and its potential influence on the autonomic nervous system. This suggests that PE might depolarize peripheral nerve synapses, alleviating chronic irritability.\n\nAlthough Valera et al. have investigated ultrasound-guided PE for neuropathies through the multifidus muscles, no studies have yet focused on PE near the tibial nerve, despite its high incidence in lumbar discopathy cases. Therefore, this study aimed to evaluate the effectiveness of US-guided PE on the tibial nerve in improving pain and muscle strength in patients with L4-L5 or L5-S1 posterolateral disc herniation compared to sham acupuncture.', 'detailedDescription': 'The study aimed to assess the effectiveness of ultrasound-guided percutaneous electrolysis (US-guided PE) in reducing pain and improving muscle strength in individuals with posterolateral lumbar disc herniations compared to placebo acupuncture.\n\nTo achieve this, a randomized, placebo-controlled, single-blindedclinical trial is proposed with two study groups:\n\n* US-guided PE:\n* Placebo acupuncture Participants in both groups received 3 sessions with periodicity 1:7:14, meaning seven days elapsed between the first and second sessions, and 14 days between the second and third sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* positive Lasegue and/or Bragard tests\n* presence of posterolateral disc herniation of the L4-L5 and/or L5-S1 vertebral segment of more than 3 months of evolution diagnosed by magnetic resonance imaging\n* presence of neuropathic symptomatology in the path of the tibial nerve\n\nExclusion Criteria:\n\n* belonephobia\n* cardiovascular or nervous pathology of medical relevance\n* surgical history in the lumbar region\n* pregnant women\n* recent or current oncologic treatment (for at least 6 months)\n* poor echogenicity in the ultrasound image of the areas to be treated'}, 'identificationModule': {'nctId': 'NCT06569069', 'briefTitle': 'Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Effectiveness of Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UG-PE in Disc Herniation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'US-guided PE', 'interventionNames': ['Other: US guided PE']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupuncture group', 'interventionNames': ['Other: Sham Acupuncture']}], 'interventions': [{'name': 'US guided PE', 'type': 'OTHER', 'description': 'The multifidus muscle near the posterior dorsal root (at L4-L5 or L5-S1) was targeted using a transverse ultrasound view, inserting the needle at an 80º short axis or a 45º long axis, based on vessel presence. For the tibial nerve in the popliteal region, the needle was inserted at an 80º angle after a transverse cut of the nerve.\n\nPhysio invasiva® needles (0.30 x 40-60 mm) were used in the lumbar region, and 0.30 x 30 mm needles in the popliteal region. Both areas received galvanic current (1.5 mA for three seconds and three impacts). Treatment included three US-guided PE sessions over a 1:7:14 schedule, though two participants skipped the third due to pain resolution.', 'armGroupLabels': ['US-guided PE']}, {'name': 'Sham Acupuncture', 'type': 'OTHER', 'description': 'Participants in the control group were also treated in a prone position. Sham acupuncture treatment was applied at the superficial level of the posterior face of the thigh on the affected side, using five "Agupunt®" needles of 0.16 x 25 mm, inserted superficially in the lateral aspect of the lumbar area (L3-L4), lateral gluteal region, greater trochanter, lateral part of the distal third of the thigh, head of the fibula and lateral aspect of the leg in its middle third. The needles were left superficially subcutaneously for 15 minutes, performing this approach in three different sessions, again following a periodicity of 1:7:14 days.', 'armGroupLabels': ['Sham acupuncture group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'University of Zaragoza', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Pablo Herrero', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Zaragoza'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Once research has been published', 'ipdSharing': 'YES', 'description': 'Data will be shared on a reasonable request contacting with the main author once data has been published.', 'accessCriteria': 'Study protocol will be publish in a scientific journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Dr. Pablo Herrero Gallego', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}