Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-13 @ 9:56 AM
Study NCT ID:
NCT03323567
Status:
COMPLETED
Last Update Posted:
2018-01-04
First Post:
2017-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}], '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': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants and care providers had no knowledge about the substance prepared for the injection. The information for the main investigator was the number of patient and the number of injection'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'patients were divided into the three groups and examination and therapy was performed after 7 and 14 days'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sEMG reduction of masseter muscle in TMD patients', 'timeFrame': '14 days', 'description': 'reduction of electromyograpic activity of masseter muscle'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['TMD, collagen, intramuscular injection, trigger point'], 'conditions': ['Temporomandibular Disorder']}, 'referencesModule': {'references': [{'pmid': '26491094', 'type': 'BACKGROUND', 'citation': 'Turo D, Otto P, Hossain M, Gebreab T, Armstrong K, Rosenberger WF, Shao H, Shah JP, Gerber LH, Sikdar S. Novel Use of Ultrasound Elastography to Quantify Muscle Tissue Changes After Dry Needling of Myofascial Trigger Points in Patients With Chronic Myofascial Pain. J Ultrasound Med. 2015 Dec;34(12):2149-61. doi: 10.7863/ultra.14.08033. Epub 2015 Oct 21.'}, {'pmid': '3343629', 'type': 'BACKGROUND', 'citation': 'Jarvholm U, Palmerud G, Styf J, Herberts P, Kadefors R. Intramuscular pressure in the supraspinatus muscle. J Orthop Res. 1988;6(2):230-8. doi: 10.1002/jor.1100060210.'}, {'pmid': '3992061', 'type': 'BACKGROUND', 'citation': 'Lehto M, Sims TJ, Bailey AJ. Skeletal muscle injury--molecular changes in the collagen during healing. Res Exp Med (Berl). 1985;185(2):95-106. doi: 10.1007/BF01854894.'}, {'pmid': '9338413', 'type': 'BACKGROUND', 'citation': 'Sorichter S, Mair J, Koller A, Gebert W, Rama D, Calzolari C, Artner-Dworzak E, Puschendorf B. Skeletal troponin I as a marker of exercise-induced muscle damage. J Appl Physiol (1985). 1997 Oct;83(4):1076-82. doi: 10.1152/jappl.1997.83.4.1076.'}, {'pmid': '26377767', 'type': 'BACKGROUND', 'citation': 'Cescon M, Gattazzo F, Chen P, Bonaldo P. Collagen VI at a glance. J Cell Sci. 2015 Oct 1;128(19):3525-31. doi: 10.1242/jcs.169748. Epub 2015 Sep 16.'}, {'pmid': '30941095', 'type': 'DERIVED', 'citation': 'Nitecka-Buchta A, Walczynska-Dragon K, Kempa WM, Baron S. Platelet-Rich Plasma Intramuscular Injections - Antinociceptive Therapy in Myofascial Pain Within Masseter Muscles in Temporomandibular Disorders Patients: A Pilot Study. Front Neurol. 2019 Mar 19;10:250. doi: 10.3389/fneur.2019.00250. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'An intramusclular injection of three solutions were performed( collagen, lidocaine, saline) in musculoskeletal trigger points, in patients suffering from temporomandibular disorders(TMD). Best results were observed in collagen group: reduction of 59,2% sEMG activity of masseter muscles and 53,75% reduction of pain intensity in VAS scale.', 'detailedDescription': 'Collagen is an important component, building myocytes and extracellular matrix of skeletal muscles. The novel treatment option for trigger point therapy and muscle regeneration in TMD patients are intramuscular collagen injections. The aim of the study was to evaluate the efficacy of intramuscular injections of Collagen MD Muscle(Guna) 2 ml, 2 ml of Lidocainum 2% without vasoconstrictor and 2 ml of Saline (0,9 % NaCl). 43 patients were enrolled to the study (17 male and 26 female, 40 +/- 3,8 years old). The masseter muscle activity was measured with sEMG Neurobit Optima 4 (Neurobit System). Visual Analogue Scale was used to determine pain intensity changes between follow-up visits in each group. Trigger points were localized with palpation of masseter muscle. Electromyographic activity of masseter muscle was measured before injections on each visit: 0, 7,14 days. In our analysis sEMG masseter muscle activity was significantly decreased: in collagen group 59,2%, in lidocainum group 39,3% and in saline group14%. Pain intensity reduction in VAS scale was 53,75% in collagen group, in lidocainum group 25% and in saline group 20,1%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- sleep bruxism, DC/TMD myofascial pain, myofascial pain with referral\n\nExclusion Criteria:\n\n* younger than 18years old, active orthodonctic treatment,neurological treatment, post radiotherapy, after head trauma within 2 years, patients with unsupported occlusal contacts, addicted to analgesic drugs, with the fear of needle'}, 'identificationModule': {'nctId': 'NCT03323567', 'briefTitle': 'A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'A Comparison of Collagen, Lidocaine and Saline Intramuscular Injections, in Myofascial Pain Patients With Trigger Points in Masseter Muscle.', 'orgStudyIdInfo': {'id': 'Silesian UM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MD Muscle Collagen group', 'description': 'Group with collagen intramuscular injections', 'interventionNames': ['Drug: MD Muscle GUNA collagen']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine 2% group', 'description': 'Group with 2% Lidocaine intramuscular injections', 'interventionNames': ['Drug: Lidocaine 2% Injectable Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Group with 0,9% NaCl intramuscular injections', 'interventionNames': ['Drug: Saline Solution, Hypertonic']}], 'interventions': [{'name': 'MD Muscle GUNA collagen', 'type': 'DRUG', 'otherNames': ['intramuscular MD Muscle collagen injection'], 'description': 'intramusclular injections of MD Muscle collagen', 'armGroupLabels': ['MD Muscle Collagen group']}, {'name': 'Lidocaine 2% Injectable Solution', 'type': 'DRUG', 'otherNames': ['intramuscular Lidocaine 2% injection'], 'description': 'intramuscular Lidocaine 2% injection', 'armGroupLabels': ['Lidocaine 2% group']}, {'name': 'Saline Solution, Hypertonic', 'type': 'DRUG', 'otherNames': ['intramuscular Saline injection'], 'description': 'intramuscular Saline injection', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Department of TMD and Orthodontics Silesian Medical University', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator D.M.D. PhD', 'investigatorFullName': 'Aleksandra Nitecka-Buchta', 'investigatorAffiliation': 'Medical University of Silesia'}}}}