Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05771220
Status:
COMPLETED
Last Update Posted:
2024-07-22
First Post:
2023-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial, single blinded, placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-03-05', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale', 'timeFrame': 'baseline, and at 7 and 12 weeks', 'description': 'Visual analogue scale for pain intensity measurement (0 (no pain) - 10 (worst pain))'}, {'measure': 'Disabilities of the Arm, Shoulder, and Hand Quick version (DASH)', 'timeFrame': 'baseline, and at 7 and 12 weeks', 'description': "Shoulder disability was measured using the Disabilities of the Arm, Shoulder, and Hand Quick version (DASH) questionnaire (0-100). It's an 11-item questionnaire that measures a patient's ability to perform specific upper extremity tasks, and higher scores on the scale indicate a higher disability. The scale ranges from 0 to 100; where higher score indicates higher disability."}], 'secondaryOutcomes': [{'measure': 'Depression Anxiety Stress Scales (DASS-12)', 'timeFrame': 'baseline, and at 7 and 12 weeks', 'description': 'Depression Anxiety Stress Scales, is made up of 12 self-report items. It is a 12-item self-report instrument designed to measure the three related negative emotional states of depression, anxiety, and tension/stress. It ranges 0-144, where higher score on the scale denotes higher endorsement of mental distress symptoms.'}, {'measure': 'Short Form-12', 'timeFrame': 'baseline, and at 7 and 12 weeks', 'description': 'The 12-Item Short Form Health Survey questionnaire (SF-12; 0-100) is a very popular instrument for evaluating Health-Related Quality of Life.HIgher score on the scale indicates better Health-Related Quality of Life.'}, {'measure': 'Range of Motion (passive and active)', 'timeFrame': 'baseline, and at 7 and 12 weeks', 'description': 'Range of Motion is measured by goniometer. Higher score on goniometer indicates better range of motion.\n\nFlexion: 0-180 Abduction: 0-180 Internal rotation: 0-90 External rotation: 0-90'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frozen shoulder', 'Extracorporeal shockwave therapy'], 'conditions': ['Adhesive Capsulitis of Shoulder']}, 'referencesModule': {'references': [{'pmid': '29200621', 'type': 'RESULT', 'citation': 'Lee S, Lee S, Jeong M, Oh H, Lee K. The effects of extracorporeal shock wave therapy on pain and range of motion in patients with adhesive capsulitis. J Phys Ther Sci. 2017 Nov;29(11):1907-1909. doi: 10.1589/jpts.29.1907. Epub 2017 Nov 24.'}, {'pmid': '31417208', 'type': 'RESULT', 'citation': 'Muthukrishnan R, Rashid AA, Al-Alkharji F. The effectiveness of extracorporeal shockwave therapy for frozen shoulder in patients with diabetes: randomized control trial. J Phys Ther Sci. 2019 Jul;31(7):493-497. doi: 10.1589/jpts.31.493. Epub 2019 Jul 2.'}, {'pmid': '19194024', 'type': 'RESULT', 'citation': 'Kelley MJ, McClure PW, Leggin BG. Frozen shoulder: evidence and a proposed model guiding rehabilitation. J Orthop Sports Phys Ther. 2009 Feb;39(2):135-48. doi: 10.2519/jospt.2009.2916.'}, {'pmid': '25104999', 'type': 'RESULT', 'citation': 'Vahdatpour B, Taheri P, Zade AZ, Moradian S. Efficacy of extracorporeal shockwave therapy in frozen shoulder. Int J Prev Med. 2014 Jul;5(7):875-81.'}, {'pmid': '28405218', 'type': 'RESULT', 'citation': 'Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7.'}, {'pmid': '30762780', 'type': 'RESULT', 'citation': 'Cao DZ, Wang CL, Qing Z, Liu LD. Effectiveness of extracorporeal shock-wave therapy for frozen shoulder: A protocol for a systematic review of randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14506. doi: 10.1097/MD.0000000000014506.'}, {'pmid': '33185587', 'type': 'RESULT', 'citation': 'Nakandala P, Nanayakkara I, Wadugodapitiya S, Gawarammana I. The efficacy of physiotherapy interventions in the treatment of adhesive capsulitis: A systematic review. J Back Musculoskelet Rehabil. 2021;34(2):195-205. doi: 10.3233/BMR-200186.'}, {'pmid': '28174448', 'type': 'RESULT', 'citation': 'Agarwal S, Raza S, Moiz JA, Anwer S, Alghadir AH. Effects of two different mobilization techniques on pain, range of motion and functional disability in patients with adhesive capsulitis: a comparative study. J Phys Ther Sci. 2016 Dec;28(12):3342-3349. doi: 10.1589/jpts.28.3342. Epub 2016 Dec 27.'}, {'pmid': '24284277', 'type': 'RESULT', 'citation': 'Jain TK, Sharma NK. The effectiveness of physiotherapeutic interventions in treatment of frozen shoulder/adhesive capsulitis: a systematic review. J Back Musculoskelet Rehabil. 2014;27(3):247-73. doi: 10.3233/BMR-130443.'}, {'pmid': '29581969', 'type': 'RESULT', 'citation': 'Yuan X, Zhou F, Zhang L, Zhang Z, Li J. Analgesic Effect of Extracorporeal Shock Wave Treatment Combined with Fascial Manipulation Theory for Adhesive Capsulitis of the Shoulder: A Retrospective Study. Biomed Res Int. 2018 Jan 18;2018:3450940. doi: 10.1155/2018/3450940. eCollection 2018.'}, {'pmid': '26834326', 'type': 'RESULT', 'citation': "Park C, Lee S, Yi CW, Lee K. The effects of extracorporeal shock wave therapy on frozen shoulder patients' pain and functions. J Phys Ther Sci. 2015 Dec;27(12):3659-61. doi: 10.1589/jpts.27.3659. Epub 2015 Dec 28."}, {'pmid': '24374758', 'type': 'RESULT', 'citation': 'Struyf F, Meeus M. Current evidence on physical therapy in patients with adhesive capsulitis: what are we missing? Clin Rheumatol. 2014 May;33(5):593-600. doi: 10.1007/s10067-013-2464-3. Epub 2013 Dec 28.'}, {'pmid': '35141337', 'type': 'RESULT', 'citation': 'Zhang R, Wang Z, Liu R, Zhang N, Guo J, Huang Y. Extracorporeal Shockwave Therapy as an Adjunctive Therapy for Frozen Shoulder: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2022 Feb 4;10(2):23259671211062222. doi: 10.1177/23259671211062222. eCollection 2022 Feb.'}, {'pmid': '32756135', 'type': 'RESULT', 'citation': 'Qiao HY, Xin L, Wu SL. Analgesic effect of extracorporeal shock-wave therapy for frozen shoulder: A randomized controlled trial protocol. Medicine (Baltimore). 2020 Jul 31;99(31):e21399. doi: 10.1097/MD.0000000000021399.'}, {'pmid': '40628437', 'type': 'DERIVED', 'citation': 'Sharahili TM, Alzahrani HA. Effect of radial extracorporeal shockwave therapy combined with evidence-based physical therapy for adhesive capsulitis of the shoulder: A randomized controlled trial. Saudi Med J. 2025 Jul;46(7):816-824. doi: 10.15537/smj.2025.46.7.20250213.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the combined effects of radial extracorporeal shockwave therapy (rESWT) and evidence-based physical therapy (EBPT) interventions for patients with adhesive capsulitis. The main questions it aims to answer are:\n\nWhat is the effectiveness of combining rESWT with EBPT interventions for the management of adhesive capsulitis compared to EBPT alone? How does the combination of rESWT and EBPT affect pain, range of motion, and functional outcomes in patients with adhesive capsulitis?\n\nResearchers will compare rESWT plus EBPT to a sham rESWT plus EBPT to see if rESWT provides better results for subjects with adhesive capsulitis.\n\nThe study will randomly assign participants to receive either rESWT plus EBPT or sham rESWT plus EBPT over a 6-week intervention period. The primary outcomes will be pain and disability, while secondary outcomes will include shoulder range of motion, psychological distress, and health-related quality of life. These outcomes will be assessed at baseline, post-intervention, and 12 weeks post-randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a relapsed or episode of pain score ≥5 at the assessment with a past history of pain for at least 2 weeks.\n* phase 1 or 2 frozen shoulder confirmed by a physician\n* ROM restriction (\\>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)\n* no treatment other than analgesics with unresponsive ROM restriction for the past 2 months\n* unwilling or waiting and did not undergo joint injection\n* Diagnosed with shoulder adhesive capsulitis,\n* ≥18 years\n* Diabetes mellitus\n\nExclusion Criteria:\n\n* bilateral shoulder involvement\n* History of previous surgery on the shoulder\n* Shoulder fracture\n* Cancer\n* Glenohumeral or Acromioclavicular arthritis\n* Inflammatory disorders\n* Bleeding disorders\n* Presence of severe osteoporosis\n* Pulmonary diseases\n* Any neuromuscular disorders\n* Pregnancy\n* Implanted pacemaker'}, 'identificationModule': {'nctId': 'NCT05771220', 'briefTitle': 'Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis', 'organization': {'class': 'OTHER', 'fullName': 'Taif University'}, 'officialTitle': 'Effectiveness of Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis Shoulder: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'A01510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'radial extracorporeal shockwave therapy+ evidence-based physical therapy', 'description': 'radial extracorporeal shockwave therapy + evidence-based physical therapy', 'interventionNames': ['Other: radial extracorporeal shockwave therapy+ evidence-based physical therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sham radial extracorporeal shockwave therapy + evidence-based physical therapy', 'description': 'sham radial extracorporeal shockwave therapy+ evidence-based physical therapy', 'interventionNames': ['Other: sham radial extracorporeal shockwave therapy+ evidence-based physical therapy']}], 'interventions': [{'name': 'radial extracorporeal shockwave therapy+ evidence-based physical therapy', 'type': 'OTHER', 'description': 'The experimental group received six sessions of rESWT over six weeks in addition to an EBPT program. The rESWT procedure involved applying shockwaves to the affected area using a radial probe, with sessions lasting 10-15 minutes and consisting of up to 2000 impulses delivered at a frequency of 3-6 pulses per second and an energy intensity level of 1.8 bar, based on patient tolerance. Patients were seated or lying down during the rESWT procedure, with gel or oil applied to facilitate shockwave transmission through the skin. Additionally, participants received a 30-minute exercise program twice a week for 6 weeks, which included hot packs, stretching, range of motion exercises, and isometric shoulder and scapular exercises. They were also instructed to perform the same exercises at home daily.', 'armGroupLabels': ['radial extracorporeal shockwave therapy+ evidence-based physical therapy']}, {'name': 'sham radial extracorporeal shockwave therapy+ evidence-based physical therapy', 'type': 'OTHER', 'description': 'The participants in the control group received six weeks of sham rESWT (radial extracorporeal shock wave therapy) combined with the EBPT (evidence-based physical therapy) program. The sham rESWT involved six sessions with a maximum of 200 impulses delivered at a low intensity, with the applicator placed on the affected area for the same duration as the experimental group. Additionally, participants received a 30-minute exercise program twice a week for 6 weeks, which included hot packs, stretching, range of motion exercises, and isometric shoulder and scapular exercises. They were also instructed to perform the same exercises at home daily.', 'armGroupLabels': ['sham radial extracorporeal shockwave therapy + evidence-based physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21477', 'city': 'Jeddah', 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'facility': 'Al-Thager General Hospital', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor; Department of Physical Therapy', 'investigatorFullName': 'Hosam Alzahrani', 'investigatorAffiliation': 'Taif University'}}}}