Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 5:38 PM
Study NCT ID:
NCT05586633
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Ultrasound-guided Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-15', 'studyFirstSubmitDate': '2022-08-14', 'studyFirstSubmitQcDate': '2022-10-15', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAİN-Visual Analog Scala (VAS)', 'timeFrame': '2nd week, 4th week, 8th week pain change', 'description': 'Visual Analog Scala (VAS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Severity of pain was assessed VAS using the standard 10 cm (back pain and leg pain) with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end.'}, {'measure': 'Quality of life - Short Form-36 (SF-36)', 'timeFrame': '2nd week, 4th week, 8th week quality of life change', 'description': 'Satisfaction assessed by the SF-36. Short Form (SF-36) was used to investigate the quality of life of the patients.The reliability and validity of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores show better Quality of life.'}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '2nd week, 4th week, 8th week pain change', 'description': "In the ODI questionnaire, the effect of low back pain on activities of daily living is questioned. In the test, which consists of 10 questions in total, the patient's pain intensity, the effects of pain on personal care, walking, lifting weights, standing, sitting, sleeping, sexual life, social life and traveling are questioned. The patient can get a minimum of 0 and a maximum of 5 points from each question. The maximum score to be taken from the test is 50. The patient's score is found by dividing the total score of the patient by 50, which is the maximum score, and calculating the percentage. (Patient's score ÷ maximum score × 100). Accordingly, it is calculated how much the patient's life activities are affected."}, {'measure': 'Physical examination-Lumbar joint range of motion examination', 'timeFrame': '2nd week, 4th week, 8th week examination change', 'description': 'Lumbar joint range of motion examination( flexion-extansion-lateral flexion-rotation)'}, {'measure': 'Physical examination-straight leg raise test', 'timeFrame': '2nd week, 4th week, 8th week examination change', 'description': 'straight leg raise test- It is recorded whether there is normal or abnormal'}, {'measure': 'Physical examination-femoral nerve stretch test', 'timeFrame': '2nd week, 4th week, 8th week examination change', 'description': 'femoral nerve stretch test - It is recorded whether there is normal or abnormal'}, {'measure': 'Physical examination-Walleix palpation', 'timeFrame': '2nd week, 4th week, 8th week examination change', 'description': 'Walleix palpation- It is recorded whether there is tenderness in Walleix palpation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low Back Pain', 'periforaminal ozon injection', 'transforaminal steroid injection', 'ultrasound guided injection'], 'conditions': ['Low Back Pain, Posterior Compartment']}, 'descriptionModule': {'briefSummary': 'Low back pain is a common disorder that every individual in the society is likely to meet throughout his/her life. Low back pain lasting longer than 12 weeks is defined as chronic low back pain and causes serious disability in the community. Conservative, pharmacological, interventional and surgical treatment options are available in its treatment. In this study, it was aimed to determine the effects of ultrasound-guided deep paravertebral periforaminal ozone injection treatment on physical examination, functional independence, quality of life and pain scores in patients with chronic low back and leg pain and to compare it with transforaminal epidural steroid injection treatment.', 'detailedDescription': 'A total of 50 patients were included in the study. Deep paravertebral periforaminal ozone injection was administered to the patients in the ozone injection group 4 times under ultrasound guidance, 10 ug/ml 5ml twice a week in the first week and 15 ug/ml 5ml twice a week in the second week. In the transforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy. The patients in both groups were offered a home exercise program for therapeutic waist and abdominal muscles to do during the treatment follow-up period. Patients\\' quality of life was evaluated with SF-36(Short Form-36), pain scores with VAS(Visüel Analog Scala) and functional evaluations with ODI(Oswestry Disability Index) at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Back and leg pain lasting longer than 3 months\n* Diagnosis of lumbar disc herniation with advanced imaging techniques after anamnesis, - physical examination and laboratory examinations\n* Continuation of complaints despite conservative treatment before\n* Regular participation in the study voluntarily\n\nExclusion Criteria:\n\n* Being pregnant and breastfeeding\n* History of lomber surgery\n* Peripheral neuropathy (diabetes, alcoholism...)\n* Cauda equina syndrome or progressive neurologic deficit in the lower extremity\n* Neurogenic bladder/bowel syndrome\n* Arterial vascular disease-Vascular claudication\n* Spinal stenosis, spondylolysis, spondylolisthesis\n* Local infection at the injection site\n* Presence of bleeding diathesis\n* Neuro-degenerative diseases\n* Uncontrolled diabetes, hypertension\n* History of malignancy\n* Uncontrolled psychiatric illness\n* BMI over 40\n* Allergy to injection substances'}, 'identificationModule': {'nctId': 'NCT05586633', 'briefTitle': 'The Efficacy of Ultrasound-guided Ozone Injection in the Treatment of Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}, 'officialTitle': 'The Efficacy of Ultrasound-guided Deep Paravertebral-periforaminal Ozone Injection in the Treatment of Patients With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': '32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'deep paravertebral- periforaminal ozone injection', 'interventionNames': ['Procedure: deep paravertebral periforaminal ozone injeciton']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'transforaminal steroid injeciton', 'interventionNames': ['Procedure: transforaminal steroid injeciton']}], 'interventions': [{'name': 'deep paravertebral periforaminal ozone injeciton', 'type': 'PROCEDURE', 'description': 'Deep paravertebral periforaminal ozone injection was administered to the patients in the ozone injection group 4 times under ultrasound guidance, 10 ug/ml 5ml twice a week in the first week and 15 ug/ml 5ml twice a week in the second week.\n\nPatients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.', 'armGroupLabels': ['deep paravertebral- periforaminal ozone injection']}, {'name': 'transforaminal steroid injeciton', 'type': 'PROCEDURE', 'description': 'Transforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy.\n\nPatients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.', 'armGroupLabels': ['transforaminal steroid injeciton']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'esra ülgen kıratlıoğlu', 'role': 'CONTACT', 'email': 'esraulgen@gmail.com', 'phone': '+905079614194'}, {'name': 'kutay tezel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'esra ülgen kıratlıoğlu', 'role': 'CONTACT', 'email': 'esraulgen@gmail.com', 'phone': '+905079614194'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sefa Gümrük Aslan', 'investigatorAffiliation': 'Gaziler Physical Medicine and Rehabilitation Education and Research Hospital'}}}}