Transcranial Direct Current Stimulation Combined With Exercise in Low Back Pain

NCT05467566 | Unknown

• 1 other identifier: LBPETCC22
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effects of transcranial direct current stimulation combined with Pilates based exercise on chronic low back pain. This is a randomized clinical trial composed of two arms.

Conditions

Low Back Pain; Transcranial Direct Current Stimulation

Keywords

Transcranial Direct Current Stimulation; Low back pain; Exercise; Chronic pain; Combined modality therapy; Motor cortex

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain intensity measured by numerical pain rating scale (11 points scale)

  Change from baseline in pain intensity at four weeks after intervention and 1 month of follow-up

• Functional performance associated to back pain

  Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 itens)

  Change from baseline in functional performance at four weeks after intervention and 1 month of follow-up

Secondary Outcomes (6)

• Pressure pain threshold

  Change from baseline in pressure pain threshold at four weeks after intervention and 1 month of follow-up

• Individual quality of life

  Change from baseline in quality of life questionnaires at four weeks after intervention and 1 month of follow-up

• Patient global impression of change

  Change from baseline in Patient global impression of change at each intervention day and at four weeks of intervention and 1 month of follow-up.

• Central Sensitization

  Change from baseline of central sensitization at four weeks after intervention and 1 month of follow-up.

• Adverse events

  Up to 4 weeks of intervention and 1 month of follow-up.

Study Arms (2)

Stimulation + exercise group

EXPERIMENTAL

30-minute exercise program (based on Pilates method) combined with active transcranial direct current stimulation.

Device: Transcranial direct current stimulation

Sham stimulation + exercise group

SHAM COMPARATOR

This arm will perform the same procedures of experimental group but the stimulator will be turned off after 30 seconds and the volunteers will not receive current for the rest of the session.

Device: Sham Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

Exercise protocol + application of active direct current stimulation for 30 minutes.

Stimulation + exercise group

Sham Transcranial direct current stimulation DEVICE

Exercise protocol + application of simulation of direct current stimulation for 30 minutes. The stimulator will be turned off after 30 seconds and the volunteers will not receive current for the rest of the session.

Sham stimulation + exercise group

Eligibility Criteria

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

You may qualify if:

• Men and women with chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale.

You may not qualify if:

• diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year;
• low cognitive level assessed by the Mini Mental State Examination;
• presence of central neurological diseases (such as Parkinson's and stroke) or psychiatric (such as depression or schizophrenia);
• history of epileptic illness;
• seizure history;
• brain implants;
• pacemaker;
• pregnancy.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Related Publications (1)

• da Silva AAC, Gomes SRA, do Nascimento RM, Fonseca AK, Pegado R, Souza CG, Macedo LB. Effects of transcranial direct current stimulation combined with Pilates-based exercises in the treatment of chronic low back pain in outpatient rehabilitation service in Brazil: double-blind randomised controlled trial protocol. BMJ Open. 2023 Dec 30;13(12):e075373. doi: 10.1136/bmjopen-2023-075373.

  PMID: 38159941 DERIVED

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Liane B Macedo, PhD

CONTACT

+55 (84) 3342-2287; liane.macedo@ufrn.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 20, 2022
• Study Start: October 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share