Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05131269
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2021-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prolotherapy Intervention in Patient With Frozen Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D014867', 'term': 'Water'}, {'id': 'D000075527', 'term': 'Prolotherapy'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'A sealed envelope of the randomized sequence was given to the investigator and care provider, and participants were recruited consecutively according to the permutation sequence. Participants were masked from the therapy by receiving treatment individually in different rooms and occasions. On the day of the assessment, the physician and laboratory technicians were blinded from group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study involves two arms assigned randomly for receiving different treatments. One arm for Prolotherapy and Normal Saline in the comparison group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2021-11-04', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Matrix Metalloproteinase 1 in Blood', 'timeFrame': 'changes of Matrix Metalloproteinase 1 value from baseline to week 6', 'description': 'Matrix Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed'}, {'measure': 'Tissue Inhibitor Metalloproteinase 1 in Blood', 'timeFrame': 'changes of Tissue Inhibitor Metalloproteinase 1 value from baseline to week 6', 'description': 'Tissue Inhibitor Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed'}], 'secondaryOutcomes': [{'measure': 'The Functional Outcome of the Shoulder', 'timeFrame': 'changes of Functional Outcome value from baseline to week 6', 'description': 'The functional outcome is measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire where the patient were asked to do simple task involving the arm, shoulder and hand and also the assessment of additional symptoms and impact to daily life. Higher score indicates disabilities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MMP-1', 'TIMP-1', 'Prolotherapy', 'Functional Outcome', 'Frozen Shoulder'], 'conditions': ['Frozen Shoulder']}, 'referencesModule': {'references': [{'pmid': '32990454', 'type': 'BACKGROUND', 'citation': 'Akcay S, Gurel Kandemir N, Kaya T, Dogan N, Eren M. Dextrose Prolotherapy Versus Normal Saline Injection for the Treatment of Lateral Epicondylopathy: A Randomized Controlled Trial. J Altern Complement Med. 2020 Dec;26(12):1159-1168. doi: 10.1089/acm.2020.0286. Epub 2020 Sep 28.'}, {'pmid': '29992159', 'type': 'BACKGROUND', 'citation': 'Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.'}, {'pmid': '21703585', 'type': 'BACKGROUND', 'citation': 'Distel LM, Best TM. Prolotherapy: a clinical review of its role in treating chronic musculoskeletal pain. PM R. 2011 Jun;3(6 Suppl 1):S78-81. doi: 10.1016/j.pmrj.2011.04.003.'}, {'pmid': '23604641', 'type': 'BACKGROUND', 'citation': 'Lubis AM, Lubis VK. Matrix metalloproteinase, tissue inhibitor of metalloproteinase and transforming growth factor-beta 1 in frozen shoulder, and their changes as response to intensive stretching and supervised neglect exercise. J Orthop Sci. 2013 Jul;18(4):519-27. doi: 10.1007/s00776-013-0387-0. Epub 2013 Apr 19.'}, {'pmid': '28027657', 'type': 'BACKGROUND', 'citation': 'Saltzman BM, Leroux T, Meyer MA, Basques BA, Chahal J, Bach BR Jr, Yanke AB, Cole BJ. The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies. Am J Sports Med. 2017 Sep;45(11):2647-2653. doi: 10.1177/0363546516680607. Epub 2016 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'Introduction :\n\nProlotherapy is regenerative tissue therapy that is considered to be efficacious in reducing symptoms and morbidity of frozen shoulder, but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Matrix Metalloproteinase- I (MMP-1), Tissue Inhibitor Matrix Metalloproteinase (TIMP-1), as the biomarkers of cartilage repair.\n\nObjective:\n\nTo determine the effect of prolotherapy on MMP-1, TIMP-1, and functional outcomes in frozen shoulder patients\n\nMethod:\n\na double-blind randomized controlled trial study involving participants who had been diagnosed with Frozen Shoulder. History taking, functional outcome assessment, MMP-1, and TIMP-1 were measured. The prolotherapy via intraarticular and extraarticular was performed four times, followed by the evaluation of functional outcome, MMP-1, and TIMP-1 at week 12\n\nAlternative Hypothesis :\n\nProlotherapy will increase the MMP-1, TIMP-1 levels, and improve functional outcome among Frozen Shoulder patients', 'detailedDescription': 'Design :\n\nDouble-blind randomized trial\n\nRandomization :\n\nSimple Randomization generated by an online randomizer\n\nSample Size :\n\nDifference between two means of primary outcome where\n\n1. mean difference (μ 1 - μ 2 ) = 0.47\n2. pool variance = 0.09\n3. Z 1-α/2 = 1.95 with type 1 error 5%\n4. 1-β = 1.282 with power 90%. Yielding 16 patients for each arm\n\nDetailed Intervention\n\n1. Intervention group: Prolotherapy is given four times (Week 0, Week 2, Week 4, and Week 6)\n2. Comparison group: Normal Saline is given four times with a timeframe similar to the intervention group\n\nInjection location\n\n1. Rotator Cuff muscles\n2. Intraarticular glenohumeral joint\n3. Subacromial bursa\n4. long-heap of the biceps tendon\n5. Acromioclavicular joint\n\nStatistical analysis :\n\n1. Descriptive statistic to elaborate baseline characteristic\n2. Assuming the baseline characteristic between groups are similar, the independent t-test will be conducted to see the differences between group, whereas Mann Whitney will be performed for nonparametric data\n3. Difference within-group (baseline and last day) will be measured by paired-t-test or Wilcoxon for non parametric scenario'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Inclusion Criteria\n\n 1. Age 35-70\n 2. Diagnosed with frozen shoulder\n 3. At least showing symptoms more than 3 months\n2. Exclusion Criteria\n\n 1. Receiving other intraarticular injection\n 2. Taking Nonsteroid Antiinflammation drugs 1 week prior to intervention\n 3. Skin disorder around the injection site\n 4. Septic arthritis'}, 'identificationModule': {'nctId': 'NCT05131269', 'briefTitle': 'Prolotherapy Intervention in Patient With Frozen Shoulder', 'organization': {'class': 'OTHER', 'fullName': 'Hasanuddin University'}, 'officialTitle': 'The Level of Matrix Metalloproteinase-1 (MMP-1), Tissue Inhibitor Matrix Metalloproteinase-1 (TIMP-1) After Prolotherapy Intervention and The Functional Outcome in Patient With Frozen Shoulder', 'orgStudyIdInfo': {'id': '0411211741'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prolotherapy', 'description': 'A solution of 7.5 ml of 15% dextrose with 2 ml of 40% lidocaine and 10.5 water is given to these shoulder segments as follows.\n\n1. Supraspinatus muscle 2-4 ml\n2. Infraspinatus muscle 2-4 ml\n3. Teres minor muscle 2-3 ml,\n4. Subscapularis muscle 2-3 ml.\n5. Intraarticular glenohumeral joint 5 ml\n6. Bursa sub acromial 1-2 ml,\n7. Long head tendon biceps 1-2 ml\n8. Acromioclavicular joint 1 ml', 'interventionNames': ['Drug: Dextrose 15 % in Water']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline 0.9%', 'description': 'A solution of 20 ml normal saline 0.9% is given to these shoulder segments as follows.\n\n1. Supraspinatus muscle 2-4 ml\n2. Infraspinatus muscle 2-4 ml\n3. Teres minor muscle 2-3 ml,\n4. Subscapularis muscle 2-3 ml.\n5. Intraarticular glenohumeral joint 5 ml\n6. Bursa sub acromial 1-2 ml,\n7. Long head tendon biceps 1-2 ml\n8. Acromioclavicular joint 1 ml', 'interventionNames': ['Drug: Normal Saline 20 mL Injection']}], 'interventions': [{'name': 'Dextrose 15 % in Water', 'type': 'DRUG', 'otherNames': ['Prolotherapy'], 'description': 'A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)', 'armGroupLabels': ['Prolotherapy']}, {'name': 'Normal Saline 20 mL Injection', 'type': 'DRUG', 'otherNames': ['Comparator'], 'description': 'A Normal Saline 0.9% is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)', 'armGroupLabels': ['Normal Saline 0.9%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90245', 'city': 'Makassar', 'state': 'South Sulawesi', 'country': 'Indonesia', 'facility': 'Hasanuddin University, Faculty of Medicine', 'geoPoint': {'lat': -5.14861, 'lon': 119.43194}}], 'overallOfficials': [{'name': 'Nuralam Sarif, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasanuddin University'}, {'name': 'Irawan Yusuf, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hasanuddin University'}, {'name': 'Endy Adnan, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hasanuddin University'}, {'name': 'Irfan Idris, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hasanuddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified data will be shared accordingly'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bumi Herman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Bumi Herman', 'investigatorAffiliation': 'Hasanuddin University'}}}}