Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design

Phase 2

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT01896453
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The purpose of this study is to evaluate the efficacy of brain and peripheral electrical stimulation on chronic non-specific low back pain patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-11
• Status Verified: 2013-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Males and females aged > 18 years and <65 years
• Complaining of back pain for more than three months
• Presence of a chronic pain measurable with the number rating scale (NRS 0-10) not less than 4 during a 1 week daily NRS monitoring
• Seeking care for low back pain

Exclusion Criteria

• Previous surgery on the spine, spondylolisthesis
• Previous treatment with TENS <6 months
• Previous treatment with tDCS
• Disc herniation with nerve compression
• Neurological, psychiatric and rheumatologic diseases
• Impaired sensibility
• Use of pacemakers or other implanted devices
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Pain intensity	Four weeks after randomization	Pain intensity will be evaluated by numerical rating scale (0-10).

Secondary Outcome Measures

Name	Time	Method
Quality of pain	4 weeks, 3 and 6 months after randomization.	The Short form of the McGill pain questionnaire (SF-MPQ) consists of 15 representative words from the sensory and affective categories of the standard long form. The 6 point intensity scale and a VAS are included to provide indices of overall pain intensity.
Disability	4 weeks, 3 and 6 months after randomization.	The Roland Morris disability questionnaire (RMDQ) is composed of 24 yes or no questions designed to assess disability related to back pain.
Pain intensity	3 and 6 months after randomization	Pain intensity will be evaluated by numerical rating scale (0-10)
Global perceived effect (GPE)	4 weeks, 3 and 6 months after randomization.	Global perceived effect is an 11 point scale that ranges from 5 (vastly worse) through 0 (no change) to 5 (completely recovered). For all measures of global perceived effect (at baseline and all follow-ups), participants were asked compared to when this episode first started, how would you describe your back these days. A higher score indicates higher recovery from the condition.

Trial Locations

Locations (1)

School of Physiotherapy - University of São Paulo; 🇧🇷 São Paulo, Brazil