NCT02387567

Paraspinal Block in Nonspecific Low Back Pain

Study on the Effects of Paraspinal Lidocaine Injection on Nonspecific Low Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Marta Imamura · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	Lidocaine	Paraspinal block with 3ml lidocaine injection at 1%.
DRUG	Sham Lidocaine	Sham injection, without lidocaine.
OTHER	Standard treatment	Standard treatment only, without lidocaine or sham injection.

Timeline

• Start date: 2007-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2015-03-13
• Last updated: 2015-03-13

Locations

1 site across 1 country: Brazil