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Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

Primary Purpose

Lumbar Disc Herniation, Sciatica, Low Back Pain, Mechanical

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bilateral SIJ injection
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lumbar Disc Herniation focused on measuring Disc Prolapse, sacroiliac joint, Injection, Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sohag university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Sacroiliac joint injection group

control group

Arm 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.

The other group will not receive the sacroiliac joint injection

Outcomes

Primary Outcome Measures

Pain assessment by visual analogue scale.
Visual analogue scale, 0 means no pain and 10 means the maximum possible pain.
Spine mobility, finger tip to floor test
comparison to the intial values with each visit to detect changes with no definite references.
Oswestry disability index
0 value means no disability and 100 means complete disability

Secondary Outcome Measures

Full Information

First Posted
March 25, 2020
Last Updated
November 3, 2020
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04326699
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Sciatica, Low Back Pain, Mechanical, Spine Stiffness
Keywords
Disc Prolapse, sacroiliac joint, Injection, Ultrasound

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sacroiliac joint injection group
Arm Type
Active Comparator
Arm 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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The other group will not receive the sacroiliac joint injection
Intervention Type
Procedure
Intervention Name(s)
Bilateral SIJ injection
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain assessment by visual analogue scale.
Description
Visual analogue scale, 0 means no pain and 10 means the maximum possible pain.
Time Frame
at baseline 0 time, after 2 weeks and after 16 weeks
Title
Spine mobility, finger tip to floor test
Description
comparison to the intial values with each visit to detect changes with no definite references.
Time Frame
Baseline 0 time, after 2 weeks and after 16 weeks
Title
Oswestry disability index
Description
0 value means no disability and 100 means complete disability
Time Frame
Baseline 0 time, after 2 weeks and after 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sohag university
City
Sohag
ZIP/Postal Code
82749
Country
Egypt

12. IPD Sharing Statement

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Bilateral Sacroiliac Joint (SIJ) Injection in Lumbar Disc Prolapse

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