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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Low Back Pain, Chronic Low-back Pain

Intervention / Treatment
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* Other: real tDCS and aerobic exercise
* Other: sham tDCS and aerobic exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability | Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability) | At baseline | 
| Disability | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Measured with Critical Flicker Fusion Threshold | At baseline | 
| Cortical excitation | Measured with Critical Flicker Fusion Threshold | At the first month after intervention onset (after completion of the 12 treatment sessions) | 
| Cortical excitation | Measured with Critical Flicker Fusion Threshold | Follow-up at the third month after treatment completion | 
| Cortical excitation | Measured with Critical Flicker Fusion Threshold | Follow-up at the sixth month after treatment completion | 
| Heart Rate Variability | Measured with Polar Heart Rate belt | At baseline | 
| Heart Rate Variability | Measured with Polar Heart Rate belt | At the first month after intervention onset (after completion of the 12 treatment sessions) | 
| Heart Rate Variability | Measured with Polar Heart Rate belt | Follow-up at the third month after treatment completion | 
| Heart Rate Variability | Measured with Polar Heart Rate belt | Follow-up at the sixth month after treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, chronic low back pain, non-specific chronic low back pain, transcranial direct current stimulation, tDCS, aerobic exercise, aerobic training, walking