Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation
Condition: Low Back Pain, Recurrent; Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Chronic low back (CLBP) pain is an important public health and socioeconomic problem
      worldwide and, despite the volume of research in the area, it remains a difficult condition
      to treat. The Neuromatrix pain model and new findings on the pain chronification process
      point to a greater efficacy of treatments that address central and peripheral rather than
      only peripheral structures.

      Transcranial direct current (tDCS) stimulation is a noninvasive neuromodulation technique
      that has been presenting recent advances in the treatment of chronic pain. However, when
      applied alone the magnitude of its effect is small in chronic musculoskeletal conditions such
      as chronic non-specific back pain. One option that could optimize the analgesic effect of
      tDCS would be the combination with therapeutic exercises, which play a central role in spinal
      rehabilitation programs as well as higher levels of evidence. The combination of these
      treatments (tDCS and exercise) may present an analgesic effect superior to the isolated
      interventions.

      This study aims to investigate the efficacy of tDCS combined with therapeutic exercises in
      people CLBP for pain relief, affective aspect of pain, disability, kinesiophobia and global
      perception. Sixty patients will be randomized into two distinct groups to receive either tDCS
      (anodal) + therapeutic exercises or tDCS (sham) + therapeutic exercises for 12 sessions over
      a four-week period. The primary clinical outcome (pain relief) and secondary outcomes
      (disability, affective aspect of pain, kinesiophobia, and perception of overall effect) will
      be collected before treatment and four weeks, three months and six months post randomization.
      The data will be collected by a blind examiner to the treatment allocation.
    


Intervention name(s): Real transcranial direct current stimulation + therapeutic exercises for back pain; Sham transcranial direct current stimulation + therapeutic exercises for back pain
Intervention type(s): Procedure; Procedure
Intervention description(s): Real transcranial direct current stimulation associated with therapeutic exercises for back pain
tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).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.; Sham transcranial direct current stimulation associated with therapeutic exercises for back pain.
tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment