Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Potentials of Bilateral Sacroiliac Joint Injection in Lumbar Disc Prolapse: a Prospective Study

Conditions
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Lumbar Disc Herniation, Sciatica, Low Back Pain, Mechanical, Spine Stiffness

Intervention / Treatment
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* Procedure: Bilateral SIJ injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sacroiliac joint injection group<br>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. | Procedure: Bilateral SIJ injection<br>* 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<br>|
| No Intervention: control group<br>The other group will not receive the sacroiliac joint injection | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disc Prolapse, sacroiliac joint, Injection, Ultrasound