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

October 3, 2018 updated by: Dr. Yoram Shir, McGill University Health Centre/Research Institute of the McGill University Health Centre

Short Term Effects of Medial Branch Block vs Para-spinal Injection in Muscle Patients With Non-specific Chronic Low Back Pain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: One side of the patient's back
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.
Other: Medial branch block in one side
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.
Other: Other side of the patient's back
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.
Other: paravertebral deep intramuscular (PDI) injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Chronic Low Back Pain (CLBP) measured by VAS
Time Frame: Seven days
Seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

August 7, 2015

First Submitted That Met QC Criteria

August 10, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-190

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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