Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT06814535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin on the Relief of Jaw Muscles Myofascial Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-08', 'studyFirstSubmitDate': '2025-01-26', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': '3 months', 'description': 'The amount of force per kilogram needed to induce pain in patients with myofascial pain at the trigger point..\n\nWill be measured using the algometer which presses on the trigger point to induce pain by force measured in kilograms/cm2 If the reading increased among the treatment visits , this means better outcome and decreased pain intensity with effectiveness of the treatment'}, {'measure': 'Current pain intensity', 'timeFrame': '3 months', 'description': 'The amount of pain on VAS at the time of examination from 0-10 With 0 no pain which increases to reach 10 ( the highest pain intensity).. Decrease in pain intensity means better outcome'}, {'measure': 'Worst pain intensity', 'timeFrame': '3 months', 'description': 'The worst pain the patient had suffered from on the previous duration. Using visual analogue scale from (0-10) with 0 least pain and 10 worst pain .\n\nDecrease in pain intensity means better outcome'}], 'secondaryOutcomes': [{'measure': 'Inter incisal opening', 'timeFrame': '3 months', 'description': 'The measurement in millimeters of the distance between the incisal edge of the upper incisor and the lower incisor Using calibers to measure the effect of myofascial pain on decreasing muscle spasm and the effectiveness of the treatment by time.\n\nIncreased degree of mouth opening meaning the muscles had relaxed and trigger points released'}, {'measure': 'Patient satisfaction', 'timeFrame': '3 months', 'description': 'Will be measured by Likert scale by faces to indicate whether the treatment was satisfactory to the patient or not and to which degree .it affected their quality of life'}, {'measure': 'The need for analgesics', 'timeFrame': '3 months', 'description': 'The patient will count how many Paracetamol tabs he took at the time from the last visit till now.\n\nWith decreased amount of analgesics taken between the visits means better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients with Jaw Muscles Myofascial Pain']}, 'descriptionModule': {'briefSummary': "This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain .\n\nThe 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles.\n\nThe 2nd group will receive ,5 ml of PRP per trigger point in masseter and/or temporalis muscles.\n\nThe 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles.\n\nThe 1st follow up session will be after 1 week then 1 month then 3 months . The patients are advised to limit excessive Mouth opening, yawning or singing. And when pain episode , theta re advised to take only paracetamol as analgesic drug .\n\nAt the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , VAS to measure the intensity of pain , Likert scale , current pain intensity, worst pain intensity and the need to take analgesics in Numbers.\n\nThen comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with myofascial trigger points in masseter or temporalis previously ----\\*identified by manual palpation.\n\n * 18 years or More "Willingness to follow instructions.\n\nExclusion Criteria:\n\n* therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint.\n\n * Clinical conditions as pregnancy\n * Medical problems that will interfere with the procedure as bleeding disorders.\n * Cognitive impairment or present inadequate cooperation.'}, 'identificationModule': {'nctId': 'NCT06814535', 'briefTitle': 'A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin on the Relief of Jaw Muscles Myofascial Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin a on the Relief of Jaw Muscles Myofascial Pain', 'orgStudyIdInfo': {'id': 'CEBD_CU_9122023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Botulinum toxin A', 'description': '20 Patients with Myofascial pain will be injected by 5 units botulinum toxin A per trigger point in masseter and/or temporalis', 'interventionNames': ['Drug: Botulinum Toxin A / Botulinum Toxin A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platelet rich plasma', 'description': '20 patients with Myofascial pain will be injected by .5 ml PRP solution per trigger point in masseter and/or temporalis'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Physiologic saline', 'description': '20 patients with Myofascial pain will be injected by.5 ml physiologic saline per each trigger point'}], 'interventions': [{'name': 'Botulinum Toxin A / Botulinum Toxin A', 'type': 'DRUG', 'description': 'Botulinum toxin type A', 'armGroupLabels': ['Botulinum toxin A']}, {'name': 'Platelet rich plasma', 'type': 'DRUG', 'description': 'Plasma that contains concentrated platelets'}, {'name': 'Saline -- placebo comparator', 'type': 'DRUG', 'description': 'Physiological saline .9 %'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Faculty of dentistry Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'asmaa abdelrahman abdelhakeem sayed', 'investigatorAffiliation': 'Cairo University'}}}}