Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
Study NCT ID:
NCT06761768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-09
First Post:
2025-01-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014221', 'term': 'Triamcinolone'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2025-01-01', 'studyFirstSubmitQcDate': '2025-01-01', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain Visual Analogue Scale(VAS)', 'timeFrame': 'baseline, one week after treatment, and at 1, 3, and 6 months post-treatment', 'description': 'The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index, ODI', 'timeFrame': 'baseline, one week after treatment, and at 1, 3, and 6 months post-treatment', 'description': 'The Oswestry Disability Index (ODI) was used to assess the degree of functional impairment caused by low back pain. The index consists of 10 items, each with 6 options scored from 0 to 5, representing varying levels of disability. A score of 0 indicates no disability, while a score of 5 indicates severe disability. The scores for all items are summed to obtain a total score, with a maximum possible score of 50, which is then expressed as a percentage.'}, {'measure': 'Quantitative scintigraphy of the sacroiliac joints', 'timeFrame': 'baseline, 3 months post-treatment', 'description': 'Quantitative scintigraphy of the sacroiliac joints is an imaging technique used to evaluate the sacroiliac joint, commonly employed to diagnose joint issues such as inflammation, joint lesions, or other pathological conditions causing pain. During the scanning process, a radiolabeled substance is typically injected into the body, which accumulates in areas of high bone activity, particularly those with inflammation or injury. This highlights metabolic activity or structural changes within the joint.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sacroiliac Joint Dysfunction', 'Sacroiliac joint pain', 'Steroid Injection', 'Extracorporeal shock wave therapy'], 'conditions': ['Sacroiliac Joint Dysfunction', 'Sacroiliac Joint Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the combined use of corticosteroid injections and ESWT for SIJ pain.', 'detailedDescription': 'The most common primary cause of pain and stiffness from the SIJ is sacroiliac joint dysfunction. Currently, conservative treatments for SIJ dysfunction-related pain include oral anti-inflammatory pain medications, exercise therapy, physical therapy, and local injection therapies such as corticosteroids, dextrose, and platelet-rich plasma. Although there are multiple non-surgical options available for SIJ pain management, clear treatment guidelines have not yet been established. Among these options, intra-articular corticosteroid injections in the SIJ are frequently used by rehabilitation specialists in clinical practice, and their effectiveness in relieving pain from SIJ dysfunction has been demonstrated. However, the effects of corticosteroids in treating musculoskeletal-related diseases are typically short-term. Extracorporeal shock wave therapy (ESWT) has become increasingly common in the management of musculoskeletal conditions such as calcific tendinitis, tennis elbow, and plantar fasciitis, showing long-lasting benefits and inducing tissue repair responses that studies suggest may last up to two years. However, literature on ESWT for lower back pain is limited, and research on its use for SIJ pain is even rarer. Therefore, this study aims to investigate the combined use of corticosteroid injections and ESWT for SIJ pain, aiming to achieve rapid, short-term pain relief through corticosteroid injections, followed by potential long-term effects through ESWT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low back pain lasting for 3 months or more\n* Pain VAS score of 4 or higher\n* Three or more positive results in sacroiliac joint provocation tests\n* At least 50% pain relief following ultrasound-guided sacroiliac joint injection with local anesthetic\n\nExclusion Criteria:\n\n* Currently undergoing extracorporeal shockwave therapy in other areas\n* Suspected pain caused by other lumbar spine or hip joint conditions (e.g., lumbar spine or disc disorders, radicular pain, spondylolisthesis/disc degeneration, hip arthritis)\n* Presence of complex comorbidities, including trauma, systemic infections (e.g., fever, chills, night sweats), local sacroiliac joint infections, autoimmune diseases, or immunosuppression\n* Sacroiliac joint injection therapy received within the past 6 months\n* Contraindications for extracorporeal shockwave therapy (e.g., cancer or current/prior infections at the treatment site, pacemakers, pregnancy, epilepsy, or coagulation disorders caused by disease or medication)\n* Impaired renal function preventing the administration of contrast agents for sacroiliac joint bone scanning'}, 'identificationModule': {'nctId': 'NCT06761768', 'briefTitle': 'Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Efficacy of Combining Corticosteroid Injections and Extracorporeal Shockwave Therapy in Patients With Sacroiliac Joint Pain', 'orgStudyIdInfo': {'id': 'B202405209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Corticosteroid Injection and shockwave Therapy', 'description': 'Participants received ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine). One week later, they began a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: low to moderate, adjusted based on patient tolerance; frequency: 5 Hz; 2000 shocks per session).', 'interventionNames': ['Drug: Corticosteroids Triamcinolone Acetonide', 'Device: extracorporeal shockwave']}, {'type': 'SHAM_COMPARATOR', 'label': 'Corticosteroid Injection and sham shockwave Therapy', 'description': 'Participants received ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine). One week later, they began a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: minimum setting on the device; frequency: 5 Hz; 2000 shocks per session).', 'interventionNames': ['Drug: Corticosteroids Triamcinolone Acetonide', 'Device: extracorporeal shockwave(minimum intensity)']}], 'interventions': [{'name': 'Corticosteroids Triamcinolone Acetonide', 'type': 'DRUG', 'description': 'ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine)', 'armGroupLabels': ['Corticosteroid Injection and sham shockwave Therapy', 'Corticosteroid Injection and shockwave Therapy']}, {'name': 'extracorporeal shockwave', 'type': 'DEVICE', 'description': 'a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: low to moderate, adjusted based on patient tolerance; frequency: 5 Hz; 2000 shocks per session)', 'armGroupLabels': ['Corticosteroid Injection and shockwave Therapy']}, {'name': 'extracorporeal shockwave(minimum intensity)', 'type': 'DEVICE', 'description': 'a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: minimum setting on the device; frequency: 5 Hz; 2000 shocks per session)', 'armGroupLabels': ['Corticosteroid Injection and sham shockwave Therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Liang cheng Chen, MD, MS', 'role': 'CONTACT', 'email': 'clctsgh@yahoo.com.tw', 'phone': '886-2-87923311', 'phoneExt': '12922'}], 'overallOfficials': [{'name': 'Liang cheng Chen, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Liang-Cheng Chen', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}