Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain

NCT06761768 | Not Yet Recruiting DMC

• 1 other identifier: B202405209
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sacroiliac Joint Dysfunction; Sacroiliac Joint Pain

Keywords

Sacroiliac Joint Dysfunction; Sacroiliac joint pain; Steroid Injection; Extracorporeal shock wave therapy

Outcome Measures

Primary Outcomes (1)

• pain Visual Analogue Scale(VAS)

  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.

  baseline, one week after treatment, and at 1, 3, and 6 months post-treatment

Secondary Outcomes (2)

• Oswestry Disability Index, ODI

  baseline, one week after treatment, and at 1, 3, and 6 months post-treatment

• Quantitative scintigraphy of the sacroiliac joints

  baseline, 3 months post-treatment

Study Arms (2)

Corticosteroid Injection and shockwave Therapy

EXPERIMENTAL

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).

Drug: Corticosteroids Triamcinolone Acetonide; Device: extracorporeal shockwave

Corticosteroid Injection and sham shockwave Therapy

SHAM COMPARATOR

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).

Drug: Corticosteroids Triamcinolone Acetonide; Device: extracorporeal shockwave(minimum intensity)

Interventions

Corticosteroids Triamcinolone Acetonide DRUG

ultrasound-guided sacroiliac joint corticosteroid injections (1 ml SHINCORT INJ 10 MG/ML + 1 ml 2% Xylocaine)

Corticosteroid Injection and sham shockwave Therapy; Corticosteroid Injection and shockwave Therapy

extracorporeal shockwave DEVICE

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)

Corticosteroid Injection and shockwave Therapy

extracorporeal shockwave(minimum intensity) DEVICE

a three-week course of weekly extracorporeal shockwave therapy sessions (intensity: minimum setting on the device; frequency: 5 Hz; 2000 shocks per session)

Corticosteroid Injection and sham shockwave Therapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

MeSH Terms

Interventions

Triamcinolone

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Liang cheng Chen, MD, MS

  Department of Physical Medicine and Rehabilitation, Tri-Service General

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang cheng Chen, MD, MS

CONTACT

886-2-87923311; clctsgh@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 7, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01