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Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation

U

Universidade Federal do Piauí

Status and phase

Completed
Phase 3
Phase 2

Conditions

Chronic Low Back Pain
Low Back Pain, Recurrent

Treatments

Procedure: Real transcranial direct current stimulation + therapeutic exercises for back pain
Procedure: Sham transcranial direct current stimulation + therapeutic exercises for back pain

Study type

Interventional

Funder types

Other

Identifiers

NCT03503422
tDCS and low back exercise

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

tDCS (anodal) + therapeutic exercises
Experimental group
Description:
Real transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
Treatment:
Procedure: Real transcranial direct current stimulation + therapeutic exercises for back pain
tDCS (sham) + therapeutic exercises
Sham Comparator group
Description:
Sham transcranial direct current stimulation associated with therapeutic exercises tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).
Treatment:
Procedure: Sham transcranial direct current stimulation + therapeutic exercises for back pain

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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