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Short Terms Effects of Medial Branch Block vs Para-spinal Muscle Injection in Patients With Non-specific CLBP

Primary Purpose

Low Back Pain, Mechanical

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Medial branch block in one side
paravertebral deep intramuscular (PDI) injection
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain, Mechanical focused on measuring Facet induced pain, Myofascial pain, Trigger points, Low back pain

Eligibility Criteria

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

Inclusion Criteria:

  • CLBP of non-malignant origin fulfilling the following criteria:

    • Pain lasting for at least three months
    • Pain in both the left and right sides of the back
    • Pain below the L2 vertebral body
  • Lumbar spine CT scan or MRI done in the last 2 years
  • Average visual analogue scale (VAS) for pain ≥4/10 on each side for the 3 days
  • Cognitive and physical ability to provide informed consent in English or French

Exclusion Criteria:

  • Neurologic signs or symptoms suggesting nerve root involvement
  • Strictly unilateral Low Back Pain (LBP)

  • CT scan or MRI findings suggestive of pain etiology beyond degenerative spine disease

    • Vascular malformations
    • Tumor
    • Infection
    • Fractures
    • DISH (Diffuse idiopathic skeletal hyperostosis)
  • Patients who have received injections of any type or acupuncture therapy to the low back in the last 3 months
  • Prior spine surgery
  • Local or systemic infection
  • Bleeding disorder or the use of anticoagulation medications but for low-dose aspirin
  • Known allergy to amid local anesthetics
  • Active insurance claim (CSST, SAAQ)
  • Uncontrolled psychiatric condition

Sites / Locations

  • Alan Edwards Pain Management Unit - Montreal General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

One side of the patient's back

Other side of the patient's back

Arm Description

medial branch block (MBB): Using sterile conditions, 25 gauge needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site.

These injections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate.

Outcomes

Primary Outcome Measures

Change in Chronic Low Back Pain (CLBP) measured by VAS

Secondary Outcome Measures

Full Information

First Posted
August 7, 2015
Last Updated
October 3, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02521519
Brief Title
Short Terms Effects of Medial Branch Block vs Para-spinal Muscle Injection in Patients With Non-specific CLBP
Official Title
Short Term Effects of Medial Branch Block vs Para-spinal Injection in Muscle Patients With Non-specific Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares the efficacy of medial branch block (MBB) vs. paravertebral deep intramuscular (PDI) injection for pain relief in chronic low back pain. Based on randomization in first intervention session, one side receives MBB and the other side takes PDI and in second session the pattern reverses.
Detailed Description
Pain relief following medial branch block (MBB) might be due to facet joints desensitization and/or myofascial trigger points' desensitization. Patients will be randomized to two groups. The first group receives MBB in one side and paravertebral deep intramuscular (PDI) injection in the other side of the back. Next week the pattern of injection will be reversed so the side which had received MBB will take PDI injection and PDI side will take MBB. Second group takes the intervention in reverse order.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
Facet induced pain, Myofascial pain, Trigger points, Low back pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One side of the patient's back
Arm Type
Other
Arm Description
medial branch block (MBB): Using sterile conditions, 25 gauge needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site.
Arm Title
Other side of the patient's back
Arm Type
Other
Arm Description
These injections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate.
Intervention Type
Other
Intervention Name(s)
Medial branch block in one side
Intervention Description
MBB: Using sterile conditions, 25G needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site.
Intervention Type
Other
Intervention Name(s)
paravertebral deep intramuscular (PDI) injection
Intervention Description
injections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate.
Primary Outcome Measure Information:
Title
Change in Chronic Low Back Pain (CLBP) measured by VAS
Time Frame
Seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CLBP of non-malignant origin fulfilling the following criteria: Pain lasting for at least three months Pain in both the left and right sides of the back Pain below the L2 vertebral body Lumbar spine CT scan or MRI done in the last 2 years Average visual analogue scale (VAS) for pain ≥4/10 on each side for the 3 days Cognitive and physical ability to provide informed consent in English or French Exclusion Criteria: Neurologic signs or symptoms suggesting nerve root involvement Strictly unilateral Low Back Pain (LBP) CT scan or MRI findings suggestive of pain etiology beyond degenerative spine disease Vascular malformations Tumor Infection Fractures DISH (Diffuse idiopathic skeletal hyperostosis) Patients who have received injections of any type or acupuncture therapy to the low back in the last 3 months Prior spine surgery Local or systemic infection Bleeding disorder or the use of anticoagulation medications but for low-dose aspirin Known allergy to amid local anesthetics Active insurance claim (CSST, SAAQ) Uncontrolled psychiatric condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoram Shir
Email
yoram.shir@muhc.mcgill.ca
Facility Information:
Facility Name
Alan Edwards Pain Management Unit - Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoram Shir, MD
Email
yoram.shir@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Linda Ferguson
Email
linda.ferguson@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Yoram Shir, MD

12. IPD Sharing Statement

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Short Terms Effects of Medial Branch Block vs Para-spinal Muscle Injection in Patients With Non-specific CLBP

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