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

U

University of Sao Paulo General Hospital

Status and phase

Completed
Phase 3
Phase 2

Conditions

Chronic Low Back Pain

Treatments

Procedure: Transcranial direct current stimulation (tDCS)
Procedure: Transcutaneous electrical nerve stimulation (TENS)

Study type

Interventional

Funder types

Other

Identifiers

NCT01896453
tDCSBACKPAIN
USaoPauloGH

Details and patient eligibility

About

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

Enrollment

92 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

92 participants in 4 patient groups

tDCS real + TENS real
Active Comparator group
Description:
Real transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS). tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
Treatment:
Procedure: Transcranial direct current stimulation (tDCS)
Procedure: Transcutaneous electrical nerve stimulation (TENS)
tDCS real + TENS sham
Experimental group
Description:
Real transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS). tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
Treatment:
Procedure: Transcranial direct current stimulation (tDCS)
Procedure: Transcutaneous electrical nerve stimulation (TENS)
tDCS sham + TENS real
Experimental group
Description:
Sham transcranial direct current stimulation associated with real transcutaneous electrical nerve stimulation (TENS). tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). TENS: 40 minutes, 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
Treatment:
Procedure: Transcranial direct current stimulation (tDCS)
Procedure: Transcutaneous electrical nerve stimulation (TENS)
Sham tDCS + Sham TENS
Sham Comparator group
Description:
Sham transcranial direct current stimulation associated with sham transcutaneous electrical nerve stimulation (TENS). tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). TENS: 40 minutes (30 seconds ON), 100Hz, 200µs, 2 channels with electrodes over the low back area of pain.
Treatment:
Procedure: Transcranial direct current stimulation (tDCS)
Procedure: Transcutaneous electrical nerve stimulation (TENS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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