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Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

NCT ID: NCT04326699

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-15

Study Completion Date

2020-10-15

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.

Conditions

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Lumbar Disc Herniation Sciatica Low Back Pain, Mechanical Spine Stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Sacroiliac joint injection group

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.

Group Type ACTIVE_COMPARATOR

Bilateral SIJ injection

Intervention Type PROCEDURE

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

control group

The other group will not receive the sacroiliac joint injection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bilateral SIJ injection

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahrous

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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15/3/2020

Identifier Type: -

Identifier Source: org_study_id