Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation
CompletedPhase 2, Phase 3NCT03503422
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation
- Interventions
- Procedure: Real transcranial direct current stimulation + therapeutic exercises for back pain
- Procedure: Sham transcranial direct current stimulation + therapeutic exercises for back pain
- Sponsor
- Universidade Federal do Piauí
- Collaborators
- Foundation for Research Support of the State of Piauí
- Start date
- 2018-04-10
- Primary completion
- 2020-02-10
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Brazil
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 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 \-
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03503422