Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation; Sciatica; Low Back Pain, Mechanical; Spine Stiffness
• Interventions: Procedure: Bilateral SIJ injection

• Registration Number: NCT04326699
• Lead Sponsor: Sohag University

Brief Summary

Bilateral sacroiliac joint injection in symptomatic lumbar disc prolapse under ultrasound guidance and studying the effect of this technique on pain, spine mobility and activity of daily living.

Detailed Description

86 Patients with lumbar disc prolapse diagnosed by either MRI or CT will be included. All of them aged \> 18 years with no special condition for the duration of disc prolapse. All of them had clinical manifestations in the form of mechanical low back pain or sciatica or limited spine mobility. All participants had no or poor response to conservative treatment. Previous surgery, severe facet arthropathy, ankylosing spondylitis, sensory or motor deficit and wedge fracture were considered as exclusion criteria. Distraction, compression, thigh thrust, and sacral thrust were used to assess SIJ dysfunction only at baseline before injection. Fingertip to floor and Oswestry disability index (ODI) were used to assess mobility and function of the spine at baseline (before and after injection) and after 2 and 16 weeks. Visual Analogue Scale (VAS) was used for pain appraisal at the same intervals. Participants will be randomly assigned into active and control group using 1:1 allocation. In the active group bilateral SIJ injection will be performed under ultrasound US guidance. Under US guidance a 22G spinal needle, where 1 mL 2 % lidocaine hydrochloride (xylocaine, AstraZeneca) mixed with triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) will be injected in each SIJ.

Study Timeline

• Study Start: 2020-03-15
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Primary Completion: 2020-09-15
• Study Completion: 2020-10-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Lumbar disc prolapse diagnosed by either MRI or CT were included.
• All of them aged > 18 years
• No special condition for the duration of disc prolapse.
• All of them had clinical manifestations in the form of mechanical low back pain or sciatica or limited spine mobility.
• All participants had no or poor response to conservative treatment

Exclusion Criteria

• Previous surgery
• Severe facet arthropathy
• Ankylosing spondylitis
• Sensory or motor deficit
• Wedge fracture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacroiliac joint injection group	Bilateral SIJ injection	The active group will receive bilateral sacroiliac joint injection of 1 mL 2 % lidocaine hydrochloride (xylocaine, AstraZeneca) mixed with triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) under ultrasound guidance.

Primary Outcome Measures

Name	Time	Method
Pain assessment by visual analogue scale.	at baseline 0 time, after 2 weeks and after 16 weeks	Visual analogue scale, 0 means no pain and 10 means the maximum possible pain.
Spine mobility, finger tip to floor test	Baseline 0 time, after 2 weeks and after 16 weeks	comparison to the intial values with each visit to detect changes with no definite references.
Oswestry disability index	Baseline 0 time, after 2 weeks and after 16 weeks	0 value means no disability and 100 means complete disability

Trial Locations

Locations (1)

Sohag university; 🇪🇬 Sohag, Egypt