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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02521519 |
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Date of registration:
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07/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Short Terms Effects of Medial Branch Block vs Para-spinal Muscle Injection in Patients With Non-specific CLBP
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Scientific 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 |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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84 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02521519 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Yoram Shir |
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Address:
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Telephone:
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Email:
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yoram.shir@muhc.mcgill.ca |
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Affiliation:
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Name:
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Yoram Shir, MD |
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Address:
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Telephone:
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Email:
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yoram.shir@muhc.mcgill.ca |
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Affiliation:
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Low Back Pain, Mechanical
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Intervention(s)
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Other: Medial branch block in one side
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Other: paravertebral deep intramuscular (PDI) injection
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Primary Outcome(s)
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Change in Chronic Low Back Pain (CLBP) measured by VAS
[Time Frame: Seven days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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