Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

Sponsor

Sohag University (Other)

Overall Status

Completed

CT.gov ID

NCT04326699

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Disc Herniation Sciatica Low Back Pain, Mechanical Spine Stiffness	Procedure: Bilateral SIJ injection	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 15, 2020

Actual Primary Completion Date :

Sep 15, 2020

Actual Study Completion Date :

Oct 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: 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
No Intervention: control group The other group will not receive the sacroiliac joint injection

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: 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

No Intervention: control group

The other group will not receive the sacroiliac joint injection

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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