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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Transcutaneous electrical nerve stimulation (TENS)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • School of Physiotherapy - University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Sham Comparator

Arm Label

tDCS real + TENS real

tDCS real + TENS sham

tDCS sham + TENS real

Sham tDCS + Sham TENS

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disability
The Roland Morris disability questionnaire (RMDQ) is composed of 24 yes or no questions designed to assess disability related to back pain.
Quality of pain
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.
Global perceived effect (GPE)
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.
Pain intensity
Pain intensity will be evaluated by numerical rating scale (0-10)

Full Information

First Posted
June 19, 2013
Last Updated
December 3, 2014
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01896453
Brief Title
Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design
Official Title
Treatment of Chronic Non-specific Low Back Pain With Brain and Peripheral Electrical Stimulation: a Factorial, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS real + TENS real
Arm Type
Active Comparator
Arm 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.
Arm Title
tDCS real + TENS sham
Arm Type
Experimental
Arm 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.
Arm Title
tDCS sham + TENS real
Arm Type
Experimental
Arm 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.
Arm Title
Sham tDCS + Sham TENS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Description
Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be evaluated by numerical rating scale (0-10).
Time Frame
Four weeks after randomization
Secondary Outcome Measure Information:
Title
Disability
Description
The Roland Morris disability questionnaire (RMDQ) is composed of 24 yes or no questions designed to assess disability related to back pain.
Time Frame
4 weeks, 3 and 6 months after randomization.
Title
Quality of pain
Description
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.
Time Frame
4 weeks, 3 and 6 months after randomization.
Title
Global perceived effect (GPE)
Description
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.
Time Frame
4 weeks, 3 and 6 months after randomization.
Title
Pain intensity
Description
Pain intensity will be evaluated by numerical rating scale (0-10)
Time Frame
3 and 6 months after randomization
Other Pre-specified Outcome Measures:
Title
Anxiety
Description
Visual analogue scale (VAS)for anxiety assesses anxiety symptoms that we tracked as possible confounding factor.
Time Frame
4 weeks, 3 and 6 months after randomization.
Title
Depression
Description
Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor.
Time Frame
4 weeks, 3 and 6 months after randomization
Title
Satisfaction with care
Description
Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care.
Time Frame
4 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuad A Hazime, PT
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia MA João, PT
Organizational Affiliation
University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
School of Physiotherapy - University of São Paulo
City
São Paulo
ZIP/Postal Code
05360-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25636503
Citation
Hazime FA, de Freitas DG, Monteiro RL, Maretto RL, Carvalho NA, Hasue RH, Joao SM. Analgesic efficacy of cerebral and peripheral electrical stimulation in chronic nonspecific low back pain: a randomized, double-blind, factorial clinical trial. BMC Musculoskelet Disord. 2015 Jan 31;16(1):7. doi: 10.1186/s12891-015-0461-1.
Results Reference
derived

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

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