Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04941118
Status:
UNKNOWN
Last Update Posted:
2021-07-21
First Post:
2021-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myofascial Pain Syndrome and Dextrose Prolotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000779', 'term': 'Anesthetics, Local'}], 'ancestors': [{'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-18', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'First month post-treatment', 'description': '0-10 cm visual scale (0: no pain, 10: most severe pain)'}, {'measure': 'Neck Disability Index', 'timeFrame': 'First month post-treatment', 'description': 'It measures the functional state of the neck by scoring between 0-5 points according to the severity of pain, consisting of 20 questions.'}, {'measure': 'Neck joint range of motion measurement', 'timeFrame': 'First month post-treatment', 'description': 'Active neck range of motion, which shows the movement of the neck in all directions, is evaluated by goniometric measurement.'}], 'secondaryOutcomes': [{'measure': 'Side effects', 'timeFrame': 'Through study completion, an average of 6 month.', 'description': 'Edema, ecchymosis, hematoma, allergic reaction, exacerbation of pain, systemic or distant side effects'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myofascial pain, dextrose prolotherapy, neck disability'], 'conditions': ['Efficacy of Dextrose Prolotherapy in Myofascial Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '29403602', 'type': 'BACKGROUND', 'citation': 'Farpour HR, Fereydooni F. Comparative effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis: A randomized clinical trial. Electron Physician. 2017 Nov 25;9(11):5663-5669. doi: 10.19082/5663. eCollection 2017 Nov.'}, {'pmid': '23690322', 'type': 'BACKGROUND', 'citation': 'Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.'}]}, 'descriptionModule': {'briefSummary': 'Myofascial pain syndrome is characterized by the presence of hypersensitive points called trigger points that cause pain, tenderness, spasm, stiffness, limitation of movement, weakness, taut band within the muscle, and pain reflected by pressing in a muscle group or a single muscle.\n\nProlotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces.\n\nIn this study, it was aimed to examine the effect of prolotherapy application on pain, neck range of motion and neck disability in women with myofascial pain syndrome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 women aged 20-50 years with a diagnosis of myofascial pain syndrome\n\nExclusion Criteria:\n\n* Cervical radiculopathy, cervical degeneration, neck surgery or trauma in the last year, injection history for myofascial pain syndrome in the last 6 months, cognitive impairment and fibromyalgia, rheumatoid arthritis, hypothyroidism, diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT04941118', 'briefTitle': 'Myofascial Pain Syndrome and Dextrose Prolotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Mustafa Kemal University'}, 'officialTitle': 'Evaluation of the Effect of Dextrose Prolotherapy on Pain and Function in Women With Myofascial Pain Syndrome', 'orgStudyIdInfo': {'id': 'MustafaKUPMR-MPS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Only saline and local anesthetic (lidocaine)', 'interventionNames': ['Drug: Local anesthetic and saline injection to the myofascial trigger point']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dextrose prolotherapy group', 'description': 'Dextrose, saline and local anesthetic (lidocaine)', 'interventionNames': ['Drug: Injection of dextrose, local anesthetic and saline to the myofascial trigger point']}], 'interventions': [{'name': 'Injection of dextrose, local anesthetic and saline to the myofascial trigger point', 'type': 'DRUG', 'description': 'An injection of 5 ml of 5% dextrose prolotherapy using 2.5 ml 10% dextrose, 1 ml 2% local anesthetic (lidocaine), 1.5 ml 0.9% saline will be administered to the active group from at least 10 trigger points.', 'armGroupLabels': ['Dextrose prolotherapy group']}, {'name': 'Local anesthetic and saline injection to the myofascial trigger point', 'type': 'DRUG', 'description': 'A total of 5 ml of solution created by using 4 ml of 0.9% saline and 1 ml of 2% local anesthetic (lidocaine) will be administered to the control group, with at least 10 trigger points.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31060', 'city': 'Hatay', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Halil Ogut, M.D.', 'role': 'CONTACT', 'email': 'oguthalil@gmail.com', 'phone': '+90 326 229 1000', 'phoneExt': '5067'}], 'facility': 'Hatay Mustafa Kemal University, Tayfur Ata Sökmen Faculty of Medicine', 'geoPoint': {'lat': 38.40227, 'lon': 27.10486}}], 'centralContacts': [{'name': 'Halil Ogut, M.D.', 'role': 'CONTACT', 'email': 'oguthalil@gmail.com', 'phone': '+90 326 229 1000', 'phoneExt': '5067'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mustafa Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Doctor', 'investigatorFullName': 'Halil Ogut', 'investigatorAffiliation': 'Mustafa Kemal University'}}}}