Clinical trial NCT03503422: Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation
Official title: Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Back Pain, Recurrent
Chronic Low Back Pain
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
Collaborators: name: Foundation for Research Support of the State of Piauí
First posted: 2018-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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Primary outcomes:
measure: Pain intensity
timeFrame: Four weeks after randomization
Secondary outcomes:
measure: Quality of pain
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Disability
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Tampa Scale for Kinesiophobia
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Global perceived effect (GPE)
timeFrame: 4 weeks, 3 and 6 months after randomization
Other outcomes:
measure: Anxiety
timeFrame: 4 weeks, 3 and 6 months after randomization
measure: Depression
timeFrame: 4 weeks, 3 and 6 months after randomization
Locations:
city: Parnaiba
country: Brazil
facility: Department of Physical Therapy. Federal University of Piaui
state: PIaui
Study officials:
affiliation: Federal University of Piaui
name: Fuad A Hazime, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cavalcante PGL, Baptista AF, Cardoso VS, Filgueiras MC, Hasue RH, Joao SMA, Hazime FA. Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial. Phys Ther. 2020 Aug 31;100(9):1595-1602. doi: 10.1093/ptj/pzaa105.