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

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

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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)