Transcranial Direct Current Stimulation (tDCS) Combined With Aerobic Exercise in Chronic Nonspecific Low Back Pain (LBP) (tDCS)

September 6, 2023 updated by: Marina Castel Sánchez, European University of Madrid

Transcranial Direct Current Stimulation Combined With Aerobic Exercise for the Treatment of Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial

The goal of this clinical trial is to learn about the effects of transcranial direct current stimulation (tDCS) combined with aerobic exercise in non-specific low back pain patients. The main question aims to answer: • Which are the effects of tDCS treatment combined with aerobic exercise compared to Sham tDCS combined with aerobic exercise in non-specific Low Back Pain? Participants will be asked to complete questionnaires and they will receive treatments as tDCS or Sham tDCS and aerobic exercise (treadmill walking). Researchers will compare a group who is treated with a combination of tDCS and aerobic exercise versus a group receiving placebo tDCS and aerobic exercise to see the effects on pain intensity, pressure pain, disability, kinesiophobia, quality of life, catastrophism, Heart Rate Variability and cortical excitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Low back pain (LBP) is the main cause of disability worldwide with a prevalence of 70 to 85% of the population. Chronic LBP (CLBP) is defined as a pain lasting more than 12 weeks. CLBP does not have peripheral nociceptive stimuli, but it is characterized by the presence of a chronic change in neuroplasticity. Transcranial direct current stimulation (tDCS) is a type of therapeutic intervention that can modulate the cortical excitability of a wide neural network involved in the elaboration of pain, resulting in an efficacy option for CLBP treatment. Aerobic exercise represents another typology of effective therapeutic intervention in the treatment of pain intensity and disability related to CLBP.

The main objective of the study is to determine the efficacy of tDCS combined with aerobic exercise compared to shame/placebo tDCS combined with aerobic exercise in middle-aged subjects with non-specific CLBP in the short, medium and long term.

Methods: In a double-blinded pilot randomized controlled trial, 38 subjects aged between 18 and 65 years, with a diagnose of non-specific LBP for 3 months, a Visual Analogue Scale (VAS) result of >20mm and a Roland-Morris Scale result of >4 will be selected for the following study. Participants will be divided in two groups of 19 subjects each one: experimental group A (20 minutes of tDCS at 2 mili Amper + 20-30 minutes of aerobic exercise at 60-80% of HRmax) and controlled group B (30 seconds of sham/placebo tDCS at 2milli amperes + 20-30 minutes of aerobic exercise at 60-80% of maximum heart rate). The following outcomes will be measured: pain intensity (100mm VAS), pressure pain (pressure algometer), disability (Roland-Morris questionnaire), kinesiophobia (Tampa Scale for kinesiophobia), quality of life (SF-12 health questionnaire), catastrophism (Pain Catastrophizing Scale), Heart Rate Variability ( Polar Team) and cortical excitation (Critical Flicker Fusion).

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Alcorcón, Spain
        • Recruiting
        • Hospital Universitario Fundacion Alcorcon
        • Contact:
          • Alvaro Lopez Hualda
    • Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of non-specific Low Back Pain for at least 3 months based on careful radiological evaluation and clinical diagnosis by a physician.
  • Aged from 18 till 65 years old.
  • Scoring higher than 20mm on the 100 mm VAS scale
  • Scoring higher than 4 on the Rolland-Morris scale

Exclusion Criteria:

Any subject presenting at least one of the following exclusion criteria will be excluded from the study:

  • Vertebral fractures, osteoporosis
  • Infections
  • Lumbar surgical, herniated disc or nerve root compression
  • Rheumatologic diseases
  • People with central nervous system alterations
  • Structured deformities of the spine (scoliosis)
  • Oncology patients in active treatment or within 5 years after the end of the treatment
  • Fibromyalgia
  • Women who are pregnant or who may be pregnant
  • Contraindications to tDCS (epilepsy, cranial implanted devices, neurological o psychiatric disorders, sever cardiopulmonary, renal or hepatic disorders)
  • Being under physiotherapeutic or osteopathic treatment during the study period
  • Absolute contraindications to aerobic exercise (acute myocardial infarction, unstable angina pectoris, uncontrolled arrhythmia, heart failure, acute pulmonary embolism, myocarditis or acute pericarditis)
  • People who need walking assistance (cane, other person to assist)
  • Patients who practise regular physical activity defined as leisure-time physical activity for 30 minutes, three or more times per week
  • People unable to give informed consent, or unable to complete the selected questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: aerobic exercise
Walk on a treadmill during 20-30 minutes at 60-80% of Heart Rate max
Other: real tDCS and aerobic exercise
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters
Other: sham tDCS and aerobic exercise
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with sham tDCS
Sham Comparator: Sham tDCS
Application of tDCS during 30 seconds of 2 mA-intensity.
Other: sham tDCS and aerobic exercise
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with sham tDCS
Experimental: real tDCS
Application of real tDCS during 20 minutes at 2 mili Amper (mA)-intensity.
Other: real tDCS and aerobic exercise
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: At baseline
Measured with Visual Analogue Scale of 100 mm
At baseline
Pain intensity
Time Frame: At the first month after intervention onset (after completion of the 12 treatment sessions).
Measured with Visual Analogue Scale of 100 mm
At the first month after intervention onset (after completion of the 12 treatment sessions).
Pain intensity
Time Frame: Follow-up at the third month after treatment completion
Measured with Visual Analogue Scale of 100 mm
Follow-up at the third month after treatment completion
Pain intensity
Time Frame: Follow-up at the sixth month after treatment completion
Measured with Visual Analogue Scale of 100 mm
Follow-up at the sixth month after treatment completion
Pressure pain
Time Frame: At baseline
Measured with a pressure algometer
At baseline
Pressure pain
Time Frame: At the first month after intervention onset (after completion of the 12 treatment sessions).
Measured with a pressure algometer
At the first month after intervention onset (after completion of the 12 treatment sessions).
Pressure pain
Time Frame: Follow-up at the third month after treatment completion
Measured with a pressure algometer
Follow-up at the third month after treatment completion
Pressure pain
Time Frame: Follow-up at the sixth month after treatment completion
Measured with a pressure algometer
Follow-up at the sixth month after treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: At baseline
Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)
At baseline
Disability
Time Frame: At the first month after intervention onset (after completion of the 12 treatment sessions).
Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)
At the first month after intervention onset (after completion of the 12 treatment sessions).
Disability
Time Frame: Follow-up at the third month after treatment completion
Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)
Follow-up at the third month after treatment completion
Disability
Time Frame: Follow-up at the sixth month after treatment completion
Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)
Follow-up at the sixth month after treatment completion
Kinesiophobia
Time Frame: At baseline
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
At baseline
Kinesiophobia
Time Frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
At the first month after intervention onset (after completion of the 12 treatment sessions)
Kinesiophobia
Time Frame: Follow-up at the third month after treatment completion
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
Follow-up at the third month after treatment completion
Kinesiophobia
Time Frame: Follow-up at the sixth month after treatment completion
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
Follow-up at the sixth month after treatment completion
Quality of life questionnaire
Time Frame: Al baseline
Measured with SF-12 Health Questionnaire Spanish version. A zero score indicates the lowest level of dimension measured by the scale, and 100 indicates the highest level of the measured dimension
Al baseline
Quality of life questionnaire
Time Frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Measured with SF-12 Health Questionnaire Spanish version. A zero score indicates the lowest level of dimension measured by the scale, and 100 indicates the highest level of the measured dimension
At the first month after intervention onset (after completion of the 12 treatment sessions)
Quality of life questionnaire
Time Frame: Follow-up at the third month after treatment completion
Measured with SF-12 Health Questionnaire Spanish version. A zero score indicates the lowest level of dimension measured by the scale, and 100 indicates the highest level of the measured dimension
Follow-up at the third month after treatment completion
Quality of life questionnaire
Time Frame: Follow-up at the sixth month after treatment completion
Measured with SF-12 Health Questionnaire Spanish version. A zero score indicates the lowest level of dimension measured by the scale, and 100 indicates the highest level of the measured dimension
Follow-up at the sixth month after treatment completion
Catastrophism
Time Frame: At baseline
Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.
At baseline
Catastrophism
Time Frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.
At the first month after intervention onset (after completion of the 12 treatment sessions)
Catastrophism
Time Frame: Follow-up at the third month after treatment completion
Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.
Follow-up at the third month after treatment completion
Catastrophism
Time Frame: Follow-up at the sixth month after treatment completion
Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.
Follow-up at the sixth month after treatment completion
Cortical excitation
Time Frame: At baseline
Measured with Critical Flicker Fusion Threshold
At baseline
Cortical excitation
Time Frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Measured with Critical Flicker Fusion Threshold
At the first month after intervention onset (after completion of the 12 treatment sessions)
Cortical excitation
Time Frame: Follow-up at the third month after treatment completion
Measured with Critical Flicker Fusion Threshold
Follow-up at the third month after treatment completion
Cortical excitation
Time Frame: Follow-up at the sixth month after treatment completion
Measured with Critical Flicker Fusion Threshold
Follow-up at the sixth month after treatment completion
Heart Rate Variability
Time Frame: At baseline
Measured with Polar Heart Rate belt
At baseline
Heart Rate Variability
Time Frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Measured with Polar Heart Rate belt
At the first month after intervention onset (after completion of the 12 treatment sessions)
Heart Rate Variability
Time Frame: Follow-up at the third month after treatment completion
Measured with Polar Heart Rate belt
Follow-up at the third month after treatment completion
Heart Rate Variability
Time Frame: Follow-up at the sixth month after treatment completion
Measured with Polar Heart Rate belt
Follow-up at the sixth month after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European University of Madrid

Investigators

  • Principal Investigator: Marina Castel Sánchez, PhD, European University of Madrid.Department of Physiotherapy, Chiropody and Dance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 17, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS&aeorbic excercise in LBP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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