Optimizing Chronic Low Back Pain Exercise Therapies With Cerebral Electrical Stimulation

NCT03503422 | Completed Phase 2 DMC

• 1 other identifier: tDCS and low back exercise
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain intensity

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

  Four weeks after randomization

Secondary Outcomes (4)

• Quality of pain

  4 weeks, 3 and 6 months after randomization

• Disability

  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

Other Outcomes (2)

• Anxiety

  4 weeks, 3 and 6 months after randomization

• Depression

  4 weeks, 3 and 6 months after randomization

Study Arms (2)

tDCS (anodal) + therapeutic exercises

EXPERIMENTAL

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).

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

tDCS (sham) + therapeutic exercises

SHAM COMPARATOR

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).

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

Interventions

Real transcranial direct current stimulation + therapeutic exercises for back pain 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 (anodal) + therapeutic exercises

Sham transcranial direct current stimulation + therapeutic exercises for back pain 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

tDCS (sham) + therapeutic exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Piauí: lead
• Foundation for Research Support of the State of Piauí: collaborator

Study Sites (1)

Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, 64202-020, Brazil

Location

Related Publications (1)

• 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.

  PMID: 32526017 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Fuad A Hazime, PhD

  Federal University of Piaui

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Physical Therapy Department

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: April 10, 2018
• Primary Completion: February 10, 2020
• Study Completion: January 15, 2021
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

BR (1)