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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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23 March 2015 |
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Main ID: |
NCT02387567 |
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Date of registration:
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22/05/2014 |
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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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Paraspinal Block in Nonspecific Low Back Pain
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Scientific title:
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Study on the Effects of Paraspinal Lidocaine Injection on Nonspecific Low Back Pain |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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378 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02387567 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Marta Imamura, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto de Medicina Física e Reabilitação HCFMUSP |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Age between 20 to 60 years;
- Clinical symptoms of vertebral pain that is unresponsive to symptomatic treatment
with anti-inflammatory drugs for 3 months;
- Moderate to severe pain: visual analog scale (VAS) > 4;
- Diagnosis of chronic nonspecific low back pain;
- MiniMental test (MEEM) between 24 and 30;
- Availability to comply with the visits;
- Agree with signing the Informed Consent Form
Exclusion criteria:
- Severe psychiatric disease that requires psychiatric care;
- Neurological disorders (lumbosciatic pain);
- Concurrent fibromyalgia, per the 1990 diagnostic criteria of the American Academy of
Rheumatology
- Concurrent rheumatic disease
- History of allergy to lidocaine (used for paraspinal blocks)
- Labor problems
- History of surgery on the lumbar spine
- No availability to visit the clinic for treatment and evaluations.
Age minimum:
20 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Low Back Pain
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Intervention(s)
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Drug: Sham Lidocaine
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Other: Standard treatment
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Drug: Lidocaine
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Primary Outcome(s)
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Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1
[Time Frame: Baseline, week 1]
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Secondary Outcome(s)
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Change from baseline in pain on the Brazilian Roland-Morris tool at week 1
[Time Frame: Baseline, week 1]
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Change from baseline in pain on the visual analog scale (VAS) score for pain
[Time Frame: Baseline, week 12]
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Change from baseline in pain on the Brazilian Roland-Morris tool at week 12
[Time Frame: baseline, week 12]
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Secondary ID(s)
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U1111-1155-7609
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PS-block-Pain
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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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