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Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

S

Sohag University

Status

Completed

Conditions

Spine Stiffness
Low Back Pain, Mechanical
Lumbar Disc Herniation
Sciatica

Treatments

Procedure: Bilateral SIJ injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04326699
15/3/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

86 participants in 2 patient groups

Sacroiliac joint injection group
Active Comparator group
Description:
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.
Treatment:
Procedure: Bilateral SIJ injection
control group
No Intervention group
Description:
The other group will not receive the sacroiliac joint injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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