Short Terms Effects of Medial Branch Block vs Para-spinal Muscle Injection in Patients With Non-specific CLBP
NCT ID: NCT02521519
Last Updated: 2018-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
84 participants
INTERVENTIONAL
2014-08-31
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Study Groups
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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.
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 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 A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk.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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Dr. Yoram Shir
Director of the Alan Edwards Pain Management Unit
Locations
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Alan Edwards Pain Management Unit - Montreal General Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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14-190
Identifier Type: -
Identifier Source: org_study_id
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