Paraspinal Block in Nonspecific Low Back Pain
- Conditions
- Chronic Low Back Pain
- Interventions
- Registration Number
- NCT02387567
- Lead Sponsor
- Marta Imamura
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 378
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine Standard treatment Paraspinal infusion of 3ml lidocaine at 1%, once a week for three weeks, combined with standard treatment. Standard treatment only Standard treatment The only intervention is the standard treatment. No lidocaine or shame injection was used. Sham lidocaine Sham Lidocaine Sham Injection, without lidocaine, combined with standard treatment. Sham lidocaine Standard treatment Sham Injection, without lidocaine, combined with standard treatment. Lidocaine Lidocaine Paraspinal infusion of 3ml lidocaine at 1%, once a week for three weeks, combined with standard treatment.
- Primary Outcome Measures
Name Time Method Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1 Baseline, week 1
- Secondary Outcome Measures
Name Time Method Change from baseline in pain on the Brazilian Roland-Morris tool at week 1 Baseline, week 1 Change from baseline in pain on the Brazilian Roland-Morris tool at week 12 baseline, week 12 Change from baseline in pain on the visual analog scale (VAS) score for pain Baseline, week 12
Trial Locations
- Locations (1)
Hospital das Clinicas
🇧🇷Sao Paulo, Brazil