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

Sponsor

European University of Madrid (Other)

Overall Status

Recruiting

CT.gov ID

NCT05830851

Collaborator

(none)

Enrollment

Locations

Arms

4.5

Anticipated Duration (Months)

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Chronic Low-back Pain	Other: tDCS and aerobic exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 17, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tDCS & aerobic exercise group This group will walk on a treadmill during 20-30 minutes at 60-80% of Heart Rate max (aerobic exercise) while receiving 20 minutes of tDCS at 2 mili Amper (mA)-intensity.	Other: tDCS and aerobic exercise Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters or sham tDCS
Sham Comparator: Sham tDCS & aerobic exercise group This group will walk on a treadmill during 20-30 minutes at 60-80% of Heart Rate max (aerobic exercise) while receiving 30 seconds of 2 mA-intensity of tDCS.	Other: tDCS and aerobic exercise Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters or sham tDCS

Arm

Intervention/Treatment

Experimental: tDCS & aerobic exercise group

This group will walk on a treadmill during 20-30 minutes at 60-80% of Heart Rate max (aerobic exercise) while receiving 20 minutes of tDCS at 2 mili Amper (mA)-intensity.

Other: tDCS and aerobic exercise

Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters or sham tDCS

Sham Comparator: Sham tDCS & aerobic exercise group

This group will walk on a treadmill during 20-30 minutes at 60-80% of Heart Rate max (aerobic exercise) while receiving 30 seconds of 2 mA-intensity of tDCS.

Other: tDCS and aerobic exercise

Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters or sham tDCS

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Disability [At baseline]
Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)
Disability [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)
Disability [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)
Disability [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)
Kinesiophobia [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.
Kinesiophobia [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.
Kinesiophobia [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.
Kinesiophobia [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.
Quality of life questionnaire [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
Quality of life questionnaire [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
Quality of life questionnaire [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
Quality of life questionnaire [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
Catastrophism [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.
Catastrophism [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.
Catastrophism [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.
Catastrophism [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.
Cortical excitation [At baseline]
Measured with Critical Flicker Fusion Threshold
Cortical excitation [At the first month after intervention onset (after completion of the 12 treatment sessions)]
Measured with Critical Flicker Fusion Threshold
Cortical excitation [Follow-up at the third month after treatment completion]
Measured with Critical Flicker Fusion Threshold
Cortical excitation [Follow-up at the sixth month after treatment completion]
Measured with Critical Flicker Fusion Threshold
Heart Rate Variability [At baseline]
Measured with Polar Heart Rate belt
Heart Rate Variability [At the first month after intervention onset (after completion of the 12 treatment sessions)]
Measured with Polar Heart Rate belt
Heart Rate Variability [Follow-up at the third month after treatment completion]
Measured with Polar Heart Rate belt
Heart Rate Variability [Follow-up at the sixth month after treatment completion]
Measured with Polar Heart Rate belt

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.