Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 179158 for:    ALL

Study Of The Efficacy Of Neurolysis In Functional Recovery From Chronic Nonspecific Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Alexandre F. Cristante, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01190033
First received: August 5, 2010
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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 placebo or sham procedure with the second group, also with 20 patients.

The neurolysis procedure will be carried out under sterile conditions, with the patient lying prone and with the neurotome insertion sites anesthetized with 2ml of 1% lidocaine. The neurotome (Smith & Nephew - RF) will be used for the procedure. The neurotome is a radiofrequency apparatus mounted on a 10cm electrode type 22 needle with a 5mm exposure tip. The neurotome should be introduced percutaneously in a manner similar to that adopted in the medial branch block through radioscopic control. The temperature of the electrode after its placement in the correct position is then raised to 80 °C for 90 seconds. Two neurotomies should be performed for each facet, one proximally and the other distally, due to double innervation of each facet. In the patients of the placebo group the procedure will be the same only the temperature of the neurotome will not be raised. This will be performed in a blind manner, as before starting the procedure, the surgeon will show the assistant who turns the device on or not the envelope containing the patient's group (placebo or neurotomy), yet the surgeon will not be informed whether the device has been turned on or not, having to perform the procedure in the same manner in both groups.

The patients will then be reevaluated in the first month, 3 months after, 6 months after and 12 months after the procedure. The assessors will not be informed of the group to which the patient belongs, and the same scales performed in the preoperative period will be used here.


Condition Intervention
Low Back Pain
Device: Neurotome OFF
Procedure: neurolysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: STUDY OF THE EFFICACY OF NEUROLYSIS IN FUNCTIONAL RECOVERY FROM CHRONIC NONSPECIFIC LOW BACK PAIN

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Pain Evaluation [ Time Frame: The Patients will be evaluated 1 week before surgery ] [ Designated as safety issue: No ]
    Pain Scores on the Visual Analog Scale

  • Pain Evaluation [ Time Frame: The Patients will be evaluated one month after surgery ] [ Designated as safety issue: No ]
    Pain Scores on the Visual Analog Scale

  • Pain Evaluation [ Time Frame: The Patients will be evaluated three months after surgery ] [ Designated as safety issue: No ]
    Pain Scores on the Visual Analog Scale

  • Pain Evaluation [ Time Frame: The Patients will be evaluated six months after surgery ] [ Designated as safety issue: No ]
    Pain Scores on the Visual Analog Scale

  • Pain Evaluation [ Time Frame: The Patients will be evaluated one year after surgery ] [ Designated as safety issue: No ]
    Pain Scores on the Visual Analog Scale


Secondary Outcome Measures:
  • Disability evaluation [ Time Frame: The Patients will be evaluated one week before surgery ] [ Designated as safety issue: No ]
    The Oswestry disability questionnaire has been designed to give us information as to how the back or leg pain is affecting the ability to manage in everyday life.

  • Medial Block Improvement [ Time Frame: one day after the medial branch block ] [ Designated as safety issue: No ]

    likert five-level scale is a scale for evaluation of improvement:

    • 0-30% improvement - no improvement
    • 30-50% improvement - moderate improvement
    • 50-80% improvement - good improvement
    • 80-100% improvement - no pain to evaluate the improvement after the medial branch block

  • Health Status [ Time Frame: The Patients will be evaluated one week before surgery ] [ Designated as safety issue: No ]
    The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.

  • Disability evaluation [ Time Frame: The Patients will be evaluated one month after surgery ] [ Designated as safety issue: No ]
    The Oswestry disability questionnaire has been designed to give us information as to how the back or leg pain is affecting the ability to manage in everyday life.

  • Disability evaluation [ Time Frame: The Patients will be evaluated three month after surgery ] [ Designated as safety issue: No ]
    The Oswestry disability questionnaire has been designed to give us information as to how the back or leg pain is affecting the ability to manage in everyday life.

  • Disability evaluation [ Time Frame: The Patients will be evaluated six month after surgery ] [ Designated as safety issue: No ]
    The Oswestry disability questionnaire has been designed to give us information as to how the back or leg pain is affecting the ability to manage in everyday life.

  • Disability evaluation [ Time Frame: The Patients will be evaluated one year after surgery ] [ Designated as safety issue: No ]
    The Oswestry disability questionnaire has been designed to give us information as to how the back or leg pain is affecting the ability to manage in everyday life.

  • Health Status [ Time Frame: The Patients will be evaluated one month after surgery ] [ Designated as safety issue: No ]
    The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.

  • Health Status [ Time Frame: The Patients will be evaluated three month after surgery ] [ Designated as safety issue: No ]
    The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.

  • Health Status [ Time Frame: The Patients will be evaluated six month after surgery ] [ Designated as safety issue: No ]
    The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.

  • Health Status [ Time Frame: The Patients will be evaluated one year after surgery ] [ Designated as safety issue: No ]
    The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: July 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neurolysis
In this intervention the neurotome will be connected
Procedure: neurolysis
In this procedure the neurotome will be connected
Placebo Comparator: Neurotome OFF
neurotome not raised
Device: Neurotome OFF
In this intervention the neurotome will be unconnected.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190033

Locations
Brazil
Institute of Orthopedics and Traumatology of the U.S.P Recruiting
Sao Paulo, SP, Brazil, 05403-010
Contact: Alexandre Cristante Fogaça    30696912    idr_77@hotmail.com   
Sub-Investigator: Ivan Dias Rocha         
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Alexandre F. Cristante, PhD., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01190033     History of Changes
Other Study ID Numbers: RIZT2010, iot 803
Study First Received: August 5, 2010
Last Updated: March 22, 2013
Health Authority: Brasil: Institutional Review Board IOT USP

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014