Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-02 @ 6:44 PM
Study NCT ID:
NCT05318560
Status:
UNKNOWN
Last Update Posted:
2022-06-23
First Post:
2022-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D010126', 'term': 'Ozone'}, {'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'Change from baseline VAS at the 1st week after the treatment.', 'description': 'The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.'}], 'secondaryOutcomes': [{'measure': 'Neck Disability Index (NDI)', 'timeFrame': 'Change from baseline VAS at the 1st week after the treatment.', 'description': 'NDI was assessed by the neck pain questionnaire that included 10 questions regarding the severity of neck pain, its impact on sleeping, driving, etc. Each question was scored from 0 to 5 and the total score was measured from 50 and was finally reported in percent (%). A higher percentage of NDI was an indicator of more disability and pain.'}, {'measure': 'Range of motion (ROM)', 'timeFrame': 'Change from baseline VAS at the 1st week after the treatment.', 'description': 'Range of motion (ROM) in neck lateral flexion movement measured according to the maximum angle that the patient could laterally bend his or her neck to the right and left side, using three consecutive times of goniometry and recording maximum value of them. Mean of the highest values of both directions was recorded as the final amount.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ozone', 'Pain'], 'conditions': ['Myofascial Pain Syndrome', 'Ozone']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators planned to compare local anesthetic injection added to stretching exercise, ozone injection treatment added to stretching exercise, and only stretching exercise in patients with upper trapezius muscle myofascial pain syndrome.', 'detailedDescription': "The investigators will recruit 72 patients with at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of myofascial pain syndrome (MAS) (according to Travell-Simons' criteria) admitted to the physical medicine and rehabilitation outpatient clinic.\n\nAge, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain of these patients will be questioned. Patients will be randomly divided into three groups. A total of 3 consecutive weeks of treatment were planned."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With at least one trigger point in the upper trapezius muscles and a clinically confirmed diagnosis of MPS\n\nExclusion Criteria:\n\n* Presence of any cervical radiculopathy or a history of degenerative conditions\n* Presence of any cervical surgery or trauma in the past year,\n* History of injection for the treatment of MAS in the last 6 months,\n* Cognitive disorder,\n* Rheumatological disease, fibromyalgia,\n* History of metabolic diseases such as hypothyroidism and diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT05318560', 'briefTitle': 'Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Comparison of the Efficacy of Local Anesthetic and Ozone Injection in Patients With Myofascial Pain Syndrome', 'orgStudyIdInfo': {'id': 'PamukkaleU-Simsek-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Local anesthetic injection', 'description': 'Patients will be injected with lidocaine and given upper trapezius muscle stretching exercises. Lidocaine injection 2cc 2% will be administered to all patients using a 26 gauge, 0.45x13 mm disposable sterile needle to the affected trigger point.', 'interventionNames': ['Drug: Lidocaine 2% Injectable Solution', 'Other: stretching exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ozone injection', 'description': 'Ozone injection will be performed on patients and upper trapezius muscle stretching exercises will be given. 8 cc of oxygen/ozone gas at a concentration of 15 µg/mL will be injected into the trigger point.', 'interventionNames': ['Drug: Ozone', 'Other: stretching exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching exercise', 'description': "Patients will be given a home program that includes upper trapezius muscle stretching exercises. Upper trapezius stretching exercises will be performed twice a day for at least 15 seconds, ten sets each time, for three weeks, with one hand on the patient's back and the other hand holding the side of the head and tilting it to the side until a slight tension is felt. The exercises will be explained in the text, visual and verbal forms with the exercise form.", 'interventionNames': ['Other: stretching exercise']}], 'interventions': [{'name': 'Lidocaine 2% Injectable Solution', 'type': 'DRUG', 'otherNames': ['jetokain simplex'], 'description': 'for MPS', 'armGroupLabels': ['Local anesthetic injection']}, {'name': 'Ozone', 'type': 'DRUG', 'description': 'for MPS', 'armGroupLabels': ['Ozone injection']}, {'name': 'stretching exercise', 'type': 'OTHER', 'description': 'for MPS', 'armGroupLabels': ['Local anesthetic injection', 'Ozone injection', 'Stretching exercise']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ayse Simsek, m.d.', 'role': 'CONTACT', 'email': 'draysesimsek2@gmail.com', 'phone': '+905319698492'}, {'name': 'Hakan Alkan, Prof.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Hakan Alkan, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Hakan Alkan', 'investigatorAffiliation': 'Pamukkale University'}}}}