NCT05651763

Brief Summary

This is a randomized and blind clinical trial, whose objective is to evaluate the effects of transcranial stimulation by direct current associated with exercises based on the pilates method on the performance of patients with chronic low back pain.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

December 6, 2022

Last Update Submit

December 14, 2022

Conditions

Low Back PainTranscranial Direct Current Stimulation

Keywords

Transcranial Direct Current StimulationLow back painExercisesChronic painPerformanceTreatment

Outcome Measures

Primary Outcomes (1)

  • Pain intensity (numerical pain rating scale)

    Pain intensity measured by numerical pain rating scale, measured on an 11-point where 0=no pain and 10=worst possible pain.

    up to 1 month of follow-up

Secondary Outcomes (4)

  • Pressure pain threshold

    A pressure pain four weeks after intervention and 1 month of follow-up

  • Root Mean Square (RMS)

    Evaluation of RMS four weeks after intervention and 1 month of follow-up

  • Peak of muscular torque

    Evaluation of Peak of muscular torque four weeks after intervention and 1 month of follow-up

  • Back muscle fatigue

    Evaluation of Back muscle fatigue four weeks after intervention and 1 month of follow-up

Study Arms (2)

Stimulation and exercise group

EXPERIMENTAL

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

Other: Stimulation and exercise group

Exercise and sham stimulation group

SHAM COMPARATOR

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

Other: Exercise and sham stimulation group

Interventions

Stimulation and exercise groupOTHER

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

Stimulation and exercise group
Exercise and sham stimulation groupOTHER

Sham Transcranial direct current stimulation 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.

Exercise and sham stimulation group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainMotor ActivityChronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jamilson S Brasileiro, PhD

CONTACT

+55 84 3342-2008brasileiro@ufrnet.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 of Physiotherapy

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 15, 2022

Study Start

January 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share