Clinical trial NCT06761768: Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain
Official title: Efficacy of Combining Corticosteroid Injections and Extracorporeal Shockwave Therapy in Patients With Sacroiliac Joint Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Sacroiliac Joint Pain
Keywords: Sacroiliac Joint Dysfunction
Sacroiliac joint pain
Steroid Injection
Extracorporeal shock wave therapy
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the combined use of corticosteroid injections and ESWT for SIJ pain.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Low back pain lasting for 3 months or more
* Pain VAS score of 4 or higher
* Three or more positive results in sacroiliac joint provocation tests
* At least 50% pain relief following ultrasound-guided sacroiliac joint injection with local anesthetic

Exclusion Criteria:

* Currently undergoing extracorporeal shockwave therapy in other areas
* 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)
* Presence of complex comorbidities, including trauma, systemic infections (e.g., fever, chills, night sweats), local sacroiliac joint infections, autoimmune diseases, or immunosuppression
* Sacroiliac joint injection therapy received within the past 6 months
* 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)
* Impaired renal function preventing the administration of contrast agents for sacroiliac joint bone scanning

Primary outcomes:
measure: pain Visual Analogue Scale(VAS)
timeFrame: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment
Secondary outcomes:
measure: Oswestry Disability Index, ODI
timeFrame: baseline, one week after treatment, and at 1, 3, and 6 months post-treatment
measure: Quantitative scintigraphy of the sacroiliac joints
timeFrame: baseline, 3 months post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General
name: Liang cheng Chen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: