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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Back Pain, Mechanical

Intervention / Treatment
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* Other: Medial branch block in one side
* Other: paravertebral deep intramuscular (PDI) injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: One side of the patient's back<br>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<br>* 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.<br>|
| Other: Other side of the patient's back<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facet induced pain, Myofascial pain, Trigger points, Low back pain