Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 8:20 PM
Study NCT ID:
NCT07325318
Status:
COMPLETED
Last Update Posted:
2026-01-08
First Post:
2025-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shockwave Dose for Adhesive Capsulitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two different shockwave doses are performed to treat adhesive capsulitis'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We assessed changes in shoulder range of motion using a standard goniometer before and after treatment with varying shockwave dosages', 'timeFrame': 'Before treatment, immediately after treatment, and at 1, 2, 4, 8, and 12 weeks post-treatment', 'description': 'In patients receiving different doses of extracorporeal shockwave therapy for adhesive capsulitis, we assessed changes in shoulder range of motion before and after treatment using a standard goniometer. We will assess forward flexion, abduction, external rotation, and internal rotation. The better the range of motion, the better the treatment outcome.'}], 'secondaryOutcomes': [{'measure': 'We assessed changes in shoulder functional outcomes using the Constant-Murley questionnaire before and after treatment with varying shockwave dosages', 'timeFrame': 'before treatment and 12 weeks posttreatment', 'description': 'In patients receiving different doses of extracorporeal shockwave therapy for adhesive capsulitis, we evaluated changes in shoulder function by administering the Constant-Murley questionnaire both before and after treatment. The questionnaire includes four subcategories: pain score (maximum 15 points), activities of daily living (maximum 20 points), movement (maximum 40 points), and strength (maximum 25 points). The Constant-Murley Score has a maximum of 100 points, with higher scores indicating a better outcome."'}, {'measure': 'The impact of changes over time before and after shockwave therapy on joint angle improvement', 'timeFrame': 'immediately after treatment and 1, 2, 4, 8, and 12 weeks posttreatment', 'description': 'We analyzed the magnitude of joint angle changes at multiple time points to compare the therapeutic effects of the various shockwaves doses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adhesive capsulitis', 'Range of motion', 'Extracorporeal shockwave therapy'], 'conditions': ['Adhesive Capsulitis, Shoulder']}, 'referencesModule': {'references': [{'pmid': '27664561', 'type': 'BACKGROUND', 'citation': 'Wang CJ, Huang CC, Yip HK, Yang YJ. Dosage effects of extracorporeal shockwave therapy in early hip necrosis. Int J Surg. 2016 Nov;35:179-186. doi: 10.1016/j.ijsu.2016.09.013. Epub 2016 Sep 21.'}, {'pmid': '32553435', 'type': 'BACKGROUND', 'citation': 'El Naggar TEDM, Maaty AIE, Mohamed AE. Effectiveness of radial extracorporeal shock-wave therapy versus ultrasound-guided low-dose intra-articular steroid injection in improving shoulder pain, function, and range of motion in diabetic patients with shoulder adhesive capsulitis. J Shoulder Elbow Surg. 2020 Jul;29(7):1300-1309. doi: 10.1016/j.jse.2020.03.005.'}, {'pmid': '14625334', 'type': 'BACKGROUND', 'citation': 'Gerdesmeyer L, Wagenpfeil S, Haake M, Maier M, Loew M, Wortler K, Lampe R, Seil R, Handle G, Gassel S, Rompe JD. Extracorporeal shock wave therapy for the treatment of chronic calcifying tendonitis of the rotator cuff: a randomized controlled trial. JAMA. 2003 Nov 19;290(19):2573-80. doi: 10.1001/jama.290.19.2573.'}, {'pmid': '32309425', 'type': 'BACKGROUND', 'citation': 'Yao G, Chen J, Duan Y, Chen X. Efficacy of Extracorporeal Shock Wave Therapy for Lateral Epicondylitis: A Systematic Review and Meta-Analysis. Biomed Res Int. 2020 Mar 18;2020:2064781. doi: 10.1155/2020/2064781. eCollection 2020.'}, {'pmid': '15334439', 'type': 'BACKGROUND', 'citation': 'Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Prevalence and impact of musculoskeletal disorders of the upper limb in the general population. Arthritis Rheum. 2004 Aug 15;51(4):642-51. doi: 10.1002/art.20535.'}], 'seeAlsoLinks': [{'url': 'https://www.richard-wolf.com/en/disciplines/shockwaves/piezowave2', 'label': 'The website describes the shockwave device used in the study as well as the underlying treatment principles.'}]}, 'descriptionModule': {'briefSummary': 'The investigators evaluated the therapeutic efficacy of different shockwave dosages for adhesive capsulitis and further examined the temporal effects and subgroup responses based on baseline range of motion', 'detailedDescription': 'The study compares two different shockwave treatment doses, each delivered as a single session to patients with adhesive capsulitis of the shoulder. We will measure shoulder range of motion before and after treatment and assess functional improvement using the Constant-Murley score. Finally, we will analyze changes in joint mobility at various post-treatment time intervals to evaluate the therapeutic effectiveness of the two shockwave dosing protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient age ≥ 20 years\n* first episode of adhesive capsulitis\n* persistent shoulder pain with restricted motion for ≥ 3 months\n* prior management limited to analgesic medications\n* active abduction in the scapular plane ≤ 135°\n\nExclusion Criteria:\n\n* shoulder or cervical pathology\n* history of shoulder fracture, infection, or tumor\n* previous shoulder surgery\n* pacemaker presence\n* pregnancy\n* coagulopathy\n* inability to complete follow-up assessments'}, 'identificationModule': {'nctId': 'NCT07325318', 'briefTitle': 'Shockwave Dose for Adhesive Capsulitis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital Hsin-Chu Branch'}, 'officialTitle': 'Study on the Dose of Extracorporeal Shockwave Therapy for Treating Adhesive Capsulitis', 'orgStudyIdInfo': {'id': '108-124-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'extracoporeal sockwave therapy basic dose', 'description': '3,000 pulses of shockwave per session as the basic treatment', 'interventionNames': ['Device: focused extracoporeal sockwave']}, {'type': 'EXPERIMENTAL', 'label': 'extracoporeal shockwave therapy high dose', 'description': '6,000 pulses of shockwave per session as the high dose treatment', 'interventionNames': ['Device: focused extracoporeal sockwave']}], 'interventions': [{'name': 'focused extracoporeal sockwave', 'type': 'DEVICE', 'description': 'Focused ESWT energy was initiated at level 5 (0.034 mJ/mm²) with a 4-Hz frequency and subsequently adjusted based on patient tolerance. After the application of coupling gel, different pulses were applied one fingerbreadth inferior to the anterior acromion, lateral to the acromion, and posterior to the acromion.', 'armGroupLabels': ['extracoporeal shockwave therapy high dose', 'extracoporeal sockwave therapy basic dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300195', 'city': 'Hsinchu', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Hsin-Chu Branch', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital Hsin-Chu Branch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}