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Clinical Trials/NCT03503422
NCT03503422
Completed
Phase 2

Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation

Universidade Federal do Piauí1 site in 1 country60 target enrollmentApril 10, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Low Back Pain, Recurrent
Sponsor
Universidade Federal do Piauí
Enrollment
60
Locations
1
Primary Endpoint
Pain intensity
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 10, 2018
End Date
January 15, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidade Federal do Piauí
Responsible Party
Principal Investigator
Principal Investigator

Fuad Ahmad Hazime

Assistant Professor - Physical Therapy Department

Universidade Federal do Piauí

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain intensity

Time Frame: Four weeks after randomization

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

Secondary Outcomes

  • Disability(4 weeks, 3 and 6 months after randomization)
  • Quality of pain(4 weeks, 3 and 6 months after randomization)
  • Tampa Scale for Kinesiophobia(4 weeks, 3 and 6 months after randomization)
  • Global perceived effect (GPE)(4 weeks, 3 and 6 months after randomization)

Study Sites (1)

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