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

Low Back Pain, Mechanical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02521519
• Other study ID #: 14-190
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2014
• Est. completion date: June 2020

Study information

• Verified date: October 2018
• Source: McGill University Health Center
• Contact: Yoram Shir
• Email: yoram.shir[@]muhc.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Alan Edwards Pain Management Unit - Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Chronic Low Back Pain (CLBP) measured by VAS		Seven days