Comparison of Diagnostic and Therapeutic Efficacy of Periarticular And/or Intraarticular Lidocaine Injections Under Ultrasound Guidance in Sacroiliac Joint Dysfunction

NCT06690463 | Active Not Recruiting

• 1 other identifier: IstanbulUC-JZare-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The sacroiliac joint (SIJ) is a joint with unique features, including both hyaline and fibrocartilage, and a discontinuous posterior capsule that enhances stability while minimizing movement. Its innervation is complex and has been a subject of debate, with various studies suggesting that it may be supplied by branches from the lumbosacral plexus, dorsal rami of S1 and S2, and the superior gluteal nerve. Recent studies have confirmed the presence of sensory nerve fibers within the joint capsule and ligaments, indicating that the SI joint is involved in pain and proprioception. Various injury mechanisms, including falls, motor vehicle accidents, and conditions like spondylolisthesis, can lead to SIJ pain. Diagnosis of sacroiliac joint pain involves physical tests, such as the thigh thrust test and compression test, while imaging techniques like scintigraphy have limited value. Provocation tests, particularly when combined, can help identify the source of pain. The primary aim of this study is to evaluate diagnostic interventions for SI joint dysfunction, while secondary aims focus on assessing factors that may affect the quality and generalizability of research on this topic.

Conditions

Sacroiliac Joint Dysfunction; Ultrasound Guided Injection; Intraarticular Injection

Keywords

sacroiliac joint dysfunction, ultrasound guided injection, Periarticular and/or Intraarticular Lidocaine Injections

Outcome Measures

Primary Outcomes (1)

• Pain Relief

  Pain will be assessed using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst pain imaginable), during standing, sitting, rising from a chair, walking, lying supine, lying on the painful side, and climbing stairs, both before and after injections into the sacroiliac joint. Higher scores indicate worse pain outcomes.

  Baseline, one hour after injection, one week, and one month

Secondary Outcomes (1)

• Overall Improvement

  One hour after injection, one week, one month

Study Arms (3)

Periarticular Lidocaine Injection

ACTIVE COMPARATOR

A 2.5 cc injection of 2% lidocaine will be administered to the periarticular area of the sacroiliac joint under ultrasound guidance

Diagnostic Test: sacroiliac joint injection

Intraarticular Lidocaine Injection

ACTIVE COMPARATOR

A 2.5 cc injection of 2% lidocaine will be administered to the articular area of the sacroiliac joint under ultrasound guidance

Diagnostic Test: sacroiliac joint injection

Periarticular and Intraarticular Lidocaine Injection

ACTIVE COMPARATOR

A total 5 cc injection of 2% lidocaine will be administered to the articular and periarticular areas of the sacroiliac joint under ultrasound guidance

Diagnostic Test: sacroiliac joint injection

Interventions

sacroiliac joint injection DIAGNOSTIC_TEST

The procedure involves the administration of a 2.5 cc injection of 2% lidocaine to the sacroiliac joint, targeting the articular or periarticular areas. The injection is performed under real-time ultrasound guidance to ensure accurate placement of the needle. The 2% lidocaine solution is injected into both the joint space (articular area) and the surrounding soft tissues (periarticular area), which may include ligaments, capsules, and adjacent muscles. The goal is to temporarily anesthetize the joint and surrounding structures to assess the contribution of the sacroiliac joint in the patient's pain, as well as to provide therapeutic pain relief. The use of ultrasound ensures minimal risk of injury to surrounding structures and enhances the accuracy of the injection. This intervention is commonly used in both diagnostic and therapeutic settings, helping to confirm the role of the sacroiliac joint in a patient's symptoms and providing relief in cases of sacroiliac joint dysfunction.

Intraarticular Lidocaine Injection; Periarticular Lidocaine Injection; Periarticular and Intraarticular Lidocaine Injection

Eligibility Criteria

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

You may qualify if:

• Patients over the age of 18 who have signed the volunteer consent form, presenting with complaints of pain radiating to the leg, which may accompany lower back and/or hip pain, and who exhibit tenderness upon palpation consistent with sacroiliac joint involvement, with a positive Fortin finger test.

You may not qualify if:

• Injection in the SI joint region (steroid, hyaluronic acid, etc.) in the last 3 months
• History of lumbar (stabilization) and/or hip (prosthesis) surgery
• Presence of inflammatory rheumatic disease
• Evidence of acute or chronic sacroiliitis on imaging
• Active infection in the gluteal area or around the lumbar region (skin, subcutaneous)
• Presence of systemic infectious disease
• Use of anticoagulants that may prevent injection
• Presence of a bleeding disorder
• Uncontrolled diabetes mellitus and/or hypertension
• Pregnancy, lactation
• Presence of psychiatric disorders

Sponsors & Collaborators

• Jale Zare: lead

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (7)

• Murakami E, Tanaka Y, Aizawa T, Ishizuka M, Kokubun S. Effect of periarticular and intraarticular lidocaine injections for sacroiliac joint pain: prospective comparative study. J Orthop Sci. 2007 May;12(3):274-80. doi: 10.1007/s00776-007-1126-1. Epub 2007 May 31.

  PMID: 17530380 BACKGROUND

• Kokmeyer DJ, Van der Wurff P, Aufdemkampe G, Fickenscher TC. The reliability of multitest regimens with sacroiliac pain provocation tests. J Manipulative Physiol Ther. 2002 Jan;25(1):42-8. doi: 10.1067/mmt.2002.120418.

  PMID: 11898017 BACKGROUND

• Laslett M. Evidence-based diagnosis and treatment of the painful sacroiliac joint. J Man Manip Ther. 2008;16(3):142-52. doi: 10.1179/jmt.2008.16.3.142.

  PMID: 19119403 BACKGROUND

• Szadek KM, van der Wurff P, van Tulder MW, Zuurmond WW, Perez RS. Diagnostic validity of criteria for sacroiliac joint pain: a systematic review. J Pain. 2009 Apr;10(4):354-68. doi: 10.1016/j.jpain.2008.09.014. Epub 2008 Dec 19.

  PMID: 19101212 BACKGROUND

• Hancock MJ, Maher CG, Latimer J, Spindler MF, McAuley JH, Laslett M, Bogduk N. Systematic review of tests to identify the disc, SIJ or facet joint as the source of low back pain. Eur Spine J. 2007 Oct;16(10):1539-50. doi: 10.1007/s00586-007-0391-1. Epub 2007 Jun 14.

  PMID: 17566796 BACKGROUND

• Bowen V, Cassidy JD. Macroscopic and microscopic anatomy of the sacroiliac joint from embryonic life until the eighth decade. Spine (Phila Pa 1976). 1981 Nov-Dec;6(6):620-8. doi: 10.1097/00007632-198111000-00015.

  PMID: 7336283 BACKGROUND

• Fortin JD. Sacroiliac Joint DysfunctionA New Perspective. J Back Musculoskelet Rehabil. 1993 Jan 1;3(3):31-43. doi: 10.3233/BMR-1993-3308.

  PMID: 24573095 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: May 22, 2024
• Primary Completion: November 22, 2024
• Study Completion: December 6, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)