Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326699
• Other study ID #: 15/3/2020
• Status: Completed
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: November 2020
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Low Back Pain
• Low Back Pain, Mechanical
• Lumbar Disc Herniation
• Prolapse
• Sciatica
• Spine Stiffness

Intervention

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

Locations

Country	Name	City	State
Egypt	Sohag university	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Oswestry disability index	0 value means no disability and 100 means complete disability	Baseline 0 time, after 2 weeks and after 16 weeks