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Clinical Trials/NCT01896453
NCT01896453
Completed
Phase 2

Treatment of Chronic Non-specific Low Back Pain With Brain and Peripheral Electrical Stimulation: a Factorial, Randomized Controlled Trial

University of Sao Paulo General Hospital1 site in 1 country92 target enrollmentJune 2013
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ConditionsChronic Low Back Pain

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
University of Sao Paulo General Hospital
Enrollment
92
Locations
1
Primary Endpoint
Pain intensity
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
December 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain intensity

Time Frame: Four weeks after randomization

Pain intensity will be evaluated by numerical rating scale (0-10).

Secondary Outcomes

  • Quality of pain(4 weeks, 3 and 6 months after randomization.)
  • Disability(4 weeks, 3 and 6 months after randomization.)
  • Pain intensity(3 and 6 months after randomization)
  • Global perceived effect (GPE)(4 weeks, 3 and 6 months after randomization.)

Study Sites (1)

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