Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-12 @ 10:07 PM
Study NCT ID:
NCT02387567
Status:
COMPLETED
Last Update Posted:
2015-03-13
First Post:
2014-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paraspinal Block in Nonspecific Low Back Pain
Sponsor:
Marta Imamura
Organization:
Study Overview
Official Title:
Study on the Effects of Paraspinal Lidocaine Injection on Nonspecific Low Back Pain
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1155-7609 | OTHER | WHO-UTN U1111-1155-7609 | View |