Paraspinal Block in Nonspecific Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Lidocaine; Sham Lidocaine; Standard treatment
Intervention type(s): Drug; Drug; Other
Intervention description(s): Paraspinal block with 3ml lidocaine injection at 1%.; Sham injection, without lidocaine.; Standard treatment only, without lidocaine or sham injection.
Other intervention name(s): 3ml lidocaine 1% Injection; 3ml sham injection; Lowback pain standard treatment
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment