Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation

NCT ID: NCT03503422

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2021-01-15

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.

Conditions

Low Back Pain, Recurrent; Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tDCS (anodal) + therapeutic exercises

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).

Group Type: EXPERIMENTAL

Real transcranial direct current stimulation + therapeutic exercises for back pain

Intervention Type: PROCEDURE

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.

tDCS (sham) + therapeutic exercises

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).

Group Type: SHAM_COMPARATOR

Sham transcranial direct current stimulation + therapeutic exercises for back pain

Intervention Type: PROCEDURE

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

Interventions

Real transcranial direct current stimulation + therapeutic exercises for back pain

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.

Intervention Type: PROCEDURE

Sham transcranial direct current stimulation + therapeutic exercises for back pain

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

Intervention Type: PROCEDURE

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Research Support of the State of Piauí

OTHER

Sponsor Role: collaborator

Universidade Federal do Piauí

OTHER

Sponsor Role: lead

Responsible Party

Fuad Ahmad Hazime

Assistant Professor - Physical Therapy Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fuad A Hazime, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Piaui

Locations

Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 32526017 (View on PubMed)

Other Identifiers

tDCS and low back exercise

Identifier Type: -

Identifier Source: org_study_id