Recruiting
Phase 3

Medial Branch Block vs. Para-spinal Muscle Injection

Sponsor:

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

Code:

NCT02521519

Conditions

Low Back Pain, Mechanical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medial branch block in one side

paravertebral deep intramuscular (PDI) injection

Study Details

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.

Conditions

Low Back Pain, Mechanical

Study ID

NCT02521519

Start date

Aug, 2014

Status verified date

Oct, 2018

Completion date

Jun, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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: 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.

Interventions

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.

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.

Primary outcome measure

  • Change in Chronic Low Back Pain (CLBP) measured by VAS [ Time Frame: Seven days ]

Central Contacts and Locations

Central contacts

Yoram Shir

yoram.shir@muhc.mcgill.ca

Locations

Alan Edwards Pain Management Unit - Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Yoram Shir, MD

yoram.shir@muhc.mcgill.ca

Linda Ferguson

linda.ferguson@muhc.mcgill.ca

Principal Investigator:

Yoram Shir, MD

More Information

Sponsor

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

Last update posted

Oct 5, 2018

Last verified

Oct, 2018

Keywords

  • Facet induced pain
  • Myofascial pain
  • Trigger points
  • Low back pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2018-10-05.