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Completed

NCT Number: NCT01896453

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

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

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

School of Physiotherapy - University of São Paulo

São Paulo, 05360-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation (tDCS)

Procedure

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

Transcutaneous electrical nerve stimulation (TENS)

Procedure

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 outcomes

  1. Pain intensity

    Time frame: Four weeks after randomization

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

Secondary outcomes

  1. Disability

    Time frame: 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.

  2. Quality of pain

    Time frame: 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.

  3. Global perceived effect (GPE)

    Time frame: 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.

  4. Pain intensity

    Time frame: 3 and 6 months after randomization

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

Other outcomes

  1. Anxiety

    Time frame: 4 weeks, 3 and 6 months after randomization.

    Visual analogue scale (VAS)for anxiety assesses anxiety symptoms that we tracked as possible confounding factor.

  2. Depression

    Time frame: 4 weeks, 3 and 6 months after randomization

    Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor.

  3. Satisfaction with care

    Time frame: 4 weeks after randomization

    Satisfaction with care will be measured by the Medrisk Instrument for Measuring Patient Satisfaction with Physiotherapy Care.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2013
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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