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Paraspinal Block in Nonspecific Low Back Pain

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ClinicalTrials.gov Identifier: NCT02387567
Recruitment Status : Completed
First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Collaborator:
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Marta Imamura, University of Sao Paulo

Brief Summary:
The purpose of this study is to investigate the effects of a treatment involving the application of lidocaine injected on the low back area for pain control. The study will compare this form of treatment with other options such as physical exercises or pain killer medication, different measurements are going to be used to quantify the response to each of these treatments.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Lidocaine Drug: Sham Lidocaine Other: Standard treatment Phase 3

Detailed Description:

This trial was conducted in the Department of Rehabilitation, Hospital das Clinicas, University, of Sao Paulo Medical School, one of the largest rehabilitation centers in Brazil. The trial was initiated in January of 2007 and close to enrollment in January of 2013. Investigators included patients with a diagnosis of chronic nonspecific low back pain who were referred from various clinics in São Paulo that were linked to this rehabilitation center. Thus, patients were referred primarily by physiatrists, general practitioners, neurologists, orthopedic surgeons, and physiotherapists.

Participants were randomized to receive: (i) paraspinal lidocaine injection (LID-INJ) and standard treatment, (ii) sham lidocaine injection (SH-INJ) and standard treatment, or (iii) standard treatment only (STD-TTR). Randomization was performed using a computerized random number generator.

Assessments The evaluations were performed by an independent and blinded appraiser before treatment, after 1 week, and 3 months after the end of the applications. Baseline assessments consisted of a demographic and baseline clinical assessment [gender, age, occupation, duration of pain (months), pain intensity, associated diseases, and usual occupation] and a physical examination [measurements of weight and height to calculate body mass index (BMI)].

Primary Outcome Measure The primary outcome measure was the visual analog scale (VAS) score for pain. The VAS comprised a 10-cm ruler from 0 to 10, with 0 corresponding to no pain and 10 corresponding to maximum pain. Patients were asked to rate their average pain in the preceding 24 hs.

Secondary Outcome Measures Investigators also measured low back pain using the Brazilian Roland-Morris tool, which consisted of a specific questionnaire to assess function in patients with low back pain and has been validated in Brazil. Scores range from 0 to 24, wherein higher scores reflect greater disability due to low back pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Effects of Paraspinal Lidocaine Injection on Nonspecific Low Back Pain
Study Start Date : January 2007
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Lidocaine
Paraspinal infusion of 3ml lidocaine at 1%, once a week for three weeks, combined with standard treatment.
Drug: Lidocaine
Paraspinal block with 3ml lidocaine injection at 1%.
Other Name: 3ml lidocaine 1% Injection

Other: Standard treatment
Standard treatment only, without lidocaine or sham injection.
Other Name: Lowback pain standard treatment

Sham Comparator: Sham lidocaine
Sham Injection, without lidocaine, combined with standard treatment.
Drug: Sham Lidocaine
Sham injection, without lidocaine.
Other Name: 3ml sham injection

Other: Standard treatment
Standard treatment only, without lidocaine or sham injection.
Other Name: Lowback pain standard treatment

Active Comparator: Standard treatment only
The only intervention is the standard treatment. No lidocaine or shame injection was used.
Other: Standard treatment
Standard treatment only, without lidocaine or sham injection.
Other Name: Lowback pain standard treatment




Primary Outcome Measures :
  1. Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1 [ Time Frame: Baseline, week 1 ]

Secondary Outcome Measures :
  1. Change from baseline in pain on the Brazilian Roland-Morris tool at week 1 [ Time Frame: Baseline, week 1 ]
  2. Change from baseline in pain on the Brazilian Roland-Morris tool at week 12 [ Time Frame: baseline, week 12 ]
  3. Change from baseline in pain on the visual analog scale (VAS) score for pain [ Time Frame: Baseline, week 12 ]

Other Outcome Measures:
  1. Adverse effects questionnaire [ Time Frame: Immediately after intervention and 3 months post application ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387567


Locations
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Brazil
Hospital das Clinicas
Sao Paulo, Brazil
Sponsors and Collaborators
Marta Imamura
Spaulding Rehabilitation Hospital
Investigators
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Principal Investigator: Marta Imamura, MD Instituto de Medicina Física e Reabilitação HCFMUSP

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marta Imamura, 1. Head of Technical Section of Physical and Rehabilitation Medicine of the Orthopedics and Traumatology Institute of HC FMUSP, Coordinator of the Center for Physical and Rehabilitation Medicine of HC FMUSP, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02387567    
Other Study ID Numbers: PS-block-Pain
U1111-1155-7609 ( Other Identifier: WHO-UTN U1111-1155-7609 )
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: March 13, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action