Clinical trial NCT04326699: Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse
Official title: Therapeutic Potentials of Bilateral Sacroiliac Joint Injection in Lumbar Disc Prolapse: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Sciatica
Low Back Pain, Mechanical
Spine Stiffness
Keywords: Disc Prolapse
sacroiliac joint
Injection
Ultrasound
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessment by visual analogue scale.
timeFrame: at baseline 0 time, after 2 weeks and after 16 weeks
measure: Spine mobility, finger tip to floor test
timeFrame: Baseline 0 time, after 2 weeks and after 16 weeks
measure: Oswestry disability index
timeFrame: Baseline 0 time, after 2 weeks and after 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References: