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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02521519
Enrollment
84
Registered
2015-08-13
Start date
2014-08-31
Completion date
2020-06-30
Last updated
2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Mechanical

Keywords

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

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.

Interventions

OTHERMedial 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.

OTHERparavertebral 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Chronic Low Back Pain (CLBP) measured by VASSeven days

Countries

Canada

Contacts

Primary ContactYoram Shir
yoram.shir@muhc.mcgill.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026