Paraspinal Block in Nonspecific Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387567
• Other study ID #: PS-block-Pain
• Secondary ID: U1111-1155-7609
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2014
• Last updated: March 12, 2015
• Start date: January 2007
• Est. completion date: January 2013

Study information

• Verified date: March 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Lidocaine
Paraspinal block with 3ml lidocaine injection at 1%.
• Sham Lidocaine
Sham injection, without lidocaine.

Other:
• Standard treatment
Standard treatment only, without lidocaine or sham injection.

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Marta Imamura	Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects questionnaire		Immediately after intervention and 3 months post application	Yes
Primary	Change from baseline in pain on the visual analog scale (VAS) score for pain at week 1		Baseline, week 1	No
Secondary	Change from baseline in pain on the Brazilian Roland-Morris tool at week 1		Baseline, week 1	No
Secondary	Change from baseline in pain on the Brazilian Roland-Morris tool at week 12		baseline, week 12	No
Secondary	Change from baseline in pain on the visual analog scale (VAS) score for pain		Baseline, week 12	No