Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2026-03-27 @ 1:15 PM
Study NCT ID:
NCT05648032
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The syringe is covered.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Tennis elbow Supraspinatus calcific tendinitis'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2022-11-20', 'studyFirstSubmitQcDate': '2022-12-04', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lateral elbow pain and shoulder pain (worst in the last one week)', 'timeFrame': '24 weeks post-injection', 'description': 'Visual analogue scale (0-10, the high the worse)'}], 'secondaryOutcomes': [{'measure': 'Lateral elbow pain and shoulder pain (worst in the last one week)', 'timeFrame': 'Baseline, 2, 4, 6, and 12 weeks post-injection', 'description': 'Visual analogue scale (0-10, the high the worse)'}, {'measure': 'Functional', 'timeFrame': 'Baseline, 2, 4, 6, 12, and 24 weeks post-injection', 'description': 'Disabilities of the Arm, Shoulder, and Hand (Score 0-100, the high the worse)'}, {'measure': 'Grasping power', 'timeFrame': 'Baseline, 2, 4, 6, 12, and 24 weeks post-injection', 'description': 'Grasping power'}, {'measure': 'Ultrasound', 'timeFrame': 'Baseline, 12 and 24 weeks post-injection', 'description': 'Tendon thickness (mm)'}, {'measure': 'Ultrasound', 'timeFrame': 'Baseline, 12 and 24 weeks post-injection', 'description': 'Calcification size (mm)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lateral Epicondylitis', 'Rotator Cuff Syndrome']}, 'descriptionModule': {'briefSummary': 'PLT vs. steroid vs. PLT + steroid, which treatment is most effective in lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis.', 'detailedDescription': "Lateral epicondylitis (or tennis elbow) and supraspinatus calcific tendinitis are common tendinopathies of the upper limb and both have negative impacts on the patients' quality of life. The former affects function of wrist extension due to degeneration of common extensor tendons; the latter causes severe pain and limitation of shoulder range of motion due to calcific deposits within the supraspinatus tendon. Current common injection therapies are ultrasound-guided injection of steroid or platelet-rich plasma (PRP).\n\nPrevious studies have shown that steroid injection provides early but short-term pain reduction, while PRP injection causes post-injection pain by inducing inflammation but provides long-term pain relief and functional improvement. It may provide early pain reduction with long-term tissue regeneration if combining steroid and PRP. A recent study on tennis elbow showed that inclusion of steroid in the autologous whole blood and 20% dextrose injection can reduce pain during early treatment, without interfering with the therapeutic effects.\n\nFurthermore, disadvantages of current PRP include difficulty in quantifying platelet numbers and growth factor activity, and in long-term preservation. In this study lyophilized platelet (PLT) can solve these problems, which can be dissolved in saline before injection.\n\nThis 3-arm randomized controlled trial will divide subjects into the PLT group (group A), steroid group (group B) or PLT+steroid group (group C). Therapeutic effects will be evaluated by pain visual analogue scale (VAS), grip dynamometer, and disabilities of the arm, shoulder, and hand (DASH) questionnaires during follow-ups at 2nd, 4th, 6th, 12th and 24th week after treatment, and ultrasound at 12th and 24th week . The hypothesis is that PLT+steroid injection will have earlier pain reduction than PLT injection and longer effects of pain reduction and functional improvement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Lateral epicondylitis\n\nInclusion Criteria:\n\n* Tenderness at lateral epicondyle more than 3 months\n* Ultrasound-confirmed lateral epicondylopathy\n* Pain VAS ≥ 3/10 during wrist resistive extension\n* No treatment response to NSAID and physiotherapy\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Carpal tunnel syndrome (the same arm) in one year\n* Cervical radiculopathy\n* Taking NSAID in one week\n* Receiving PRP or steroid injection in one month\n* History of bacteremia, cellulitis or skin ulcer in three months\n* Rheumatoid arthritis\n* Malignancy\n* Poorly controlled diabetets mellitus (DM), liver and kidner diseases\n* Severe anemia (Hb\\<5)\n* Thrombocytopenia\n* History of tennis elbow surgery\n* History of elbow trauma\n\nSupraspinatus calcific tendinis\n\nInclusion Criteria:\n\n* Hawkins-Kennedy test or empty can test, one of which is positive\n* Ultrasound-confirmed (calcification \\> 2mm)\n* Pain VAS ≥ 3/10 over right deltoid area more than 3 months\n* No treatment response to NSAID and physiotherapy\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Carpal tunnel syndrome (the same arm) in one year\n* Cervical radiculopathy\n* Taking NSAID in one week\n* Receiving PRP or steroid injection in one month\n* History of bacteremia, cellulitis or skin ulcer in three months\n* Rheumatoid arthritis\n* Malignancy\n* Poorly controlled DM, liver and kidner diseases\n* Severe anemia (Hb\\<5)\n* Thrombocytopenia\n* History of shoulder surgery\n* History of shoulder trauma'}, 'identificationModule': {'nctId': 'NCT05648032', 'briefTitle': 'PLT and Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Clinical Application of PLT Combined With Steroid in Lateral Epicondylopathy and Supraspinatus Calcific Tendinopathy', 'orgStudyIdInfo': {'id': '201903076DIPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PLT (lyophilized platelet) with steroid', 'description': 'PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once', 'interventionNames': ['Combination Product: lyophilized platelet (30ng) and triamcinolone acetonide 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'PLT (lyophilized platelet)', 'description': 'PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline, once', 'interventionNames': ['Other: lyophilized platelet (30ng)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid', 'description': '1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide, once', 'interventionNames': ['Drug: triamcinolone acetonide 10mg']}], 'interventions': [{'name': 'lyophilized platelet (30ng) and triamcinolone acetonide 10mg', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['PLT and steroid'], 'description': 'Ultrasound-guided injection of lyophilized platelet (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide into the hypoechoic area of common extensor tendon (in lateral epicondylopathy) or around calcific spots (in supraspinatus calcific tendinitis)', 'armGroupLabels': ['PLT (lyophilized platelet) with steroid']}, {'name': 'lyophilized platelet (30ng)', 'type': 'OTHER', 'otherNames': ['Blood product'], 'description': 'Ultrasound-guided injection of PLT (30ng)+1.0 mL 1.0% Lidocaine+1.0 mL normal saline into the hypoechoic area of common extensor tendon (in lateral epicondylopathy) or around calcific spots (in supraspinatus calcific tendinitis)', 'armGroupLabels': ['PLT (lyophilized platelet)']}, {'name': 'triamcinolone acetonide 10mg', 'type': 'DRUG', 'otherNames': ['steroid'], 'description': 'Ultrasound-guided injection of 1.0 mL 1.0% Lidocaine+1.0 mL (10.0 mg/mL) Triamcinolone acetonide into the hypoechoic area of common extensor tendon (in lateral epicondylopathy) or around calcific spots (in supraspinatus calcific tendinitis)', 'armGroupLabels': ['Steroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wan-Ju Chien, M.S.', 'role': 'CONTACT', 'email': 'wanzu21@gmail.com', 'phone': '886-2-23123456', 'phoneExt': '266473'}, {'name': 'Chueh-Hung Wu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chueh-Hung Wu, MD, PhD', 'role': 'CONTACT', 'email': 'nojred@gmail.com', 'phone': '886-2-23123456', 'phoneExt': '266473'}], 'overallOfficials': [{'name': 'Chueh-Hung Wu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}