Study Of The Efficacy Of Neurolysis In Functional Recovery From Chronic Nonspecific Low Back Pain
Unknown statusNot applicableNCT01190033
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This is a prospective, randomized, double-blind, placebo-controlled study. In an initial phase, 100 patients with chronic low back pain will be included in this study. The patients will be recruited through magazines and newspapers to take part in a screening for treatment of low back pain. This screening will involve the evaluation of data such as history and physical examination to classify the patient in the group of nonspecific low back pain, excluding patients with neurological alterations and the so-called Red-Flags. Procedures After the initial screening the patients will undergo diagnostic blocks of the medial branch of lumbar vertebrae L2, L3, L4 , L5 and of the first sacral vertebra (S1) with lidocaine and control with distilled water. The patients that present more than 50% of pain improvement, evaluated by the Likert scale after 30 minutes will form the study group, while the patients that do not present pain improvement with lidocaine or that present pain improvement with distilled water will be excluded. The medial branch block consists of the insertion of a 90mm, 25-gauge needle through the skin with radioscopic control up to the medial branch topography. Infusion of 1ml of 2% lidocaine should be performed in each medial branch of the abovementioned vertebrae. Control is executed in the same manner yet with infusion of 1ml of distilled water. Through the use of the diagnostic block we will have 40 patients selected for the second phase of the study. Once defined the study group should be evaluated before the procedure through the Oswestry, Roland Morris, SF-36 and VAS questionnaires. In the second phase of the study the patients will be randomized. The random division into two groups will be performed through a computerized program of random numbers. The randomization result will be kept in matt sealed envelopes to guarantee secrecy of the allocation. The neurolysis procedure will be carried out in the first group, consisting of 20 patients, and the p…
Study details
- Official title
- Study Of The Efficacy Of Neurolysis In Functional Recovery From Chronic Nonspecific Low Back Pain
- Conditions
- Interventions
- Device: Neurotome OFF
- Procedure: neurolysis
- Sponsor
- University of Sao Paulo
- Start date
- 2010-08
- Primary completion
- 2012-07
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Brazil
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * clinical diagnosis of lumbar pain in a patient with age between 20 and 60 years. * present clinical complaints of low back pain for 3 months or more. * present pain of moderate to severe intensity: visual analogue scale (VAS) \> 4. Exclusion Criteria: * patients that develop a profile compatible with specific low back pain during treatment. * patients that request their withdrawal from the study at any time. * patients that develop an allergy to the medication used.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01190033