Combined Corticosteroid Injections and Shockwave Therapy for Sacroiliac Joint Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-75
SponsorTri-Service General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Corticosteroids Triamcinolone Acetonide

    Drug

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

  • 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)

  • 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)

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Corticosteroid Injection and shockwave TherapyExperimental treatment 2 interventions
Group B: Corticosteroid Injection and sham shockwave TherapySham comparator 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Oswestry Disability Index, ODI

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.

Time frame
baseline, one week after treatment, and at 1, 3, and 6 months post-treatment
2

Quantitative scintigraphy of the sacroiliac joints

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.

Time frame
baseline, 3 months post-treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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