Clinical trial NCT05830851: Transcranial Direct Current Stimulation (tDCS) Combined With Aerobic Exercise in Chronic Nonspecific Low Back Pain (LBP)
Official title: Transcranial Direct Current Stimulation Combined With Aerobic Exercise for the Treatment of Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Chronic Low-back Pain
Keywords: low back pain
chronic low back pain
non-specific chronic low back pain
transcranial direct current stimulation
tDCS
aerobic exercise
aerobic training
walking
Lead sponsor: European University of Madrid
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: At baseline
measure: Pain intensity
timeFrame: At the first month after intervention onset (after completion of the 12 treatment sessions).
measure: Pain intensity
timeFrame: Follow-up at the third month after treatment completion
measure: Pain intensity
timeFrame: Follow-up at the sixth month after treatment completion
measure: Pressure pain
timeFrame: At baseline
measure: Pressure pain
timeFrame: At the first month after intervention onset (after completion of the 12 treatment sessions).
measure: Pressure pain
timeFrame: Follow-up at the third month after treatment completion
measure: Pressure pain
timeFrame: Follow-up at the sixth month after treatment completion
Secondary outcomes:
measure: Disability
timeFrame: At baseline
measure: Disability
timeFrame: At the first month after intervention onset (after completion of the 12 treatment sessions).
measure: Disability
timeFrame: Follow-up at the third month after treatment completion
measure: Disability
timeFrame: Follow-up at the sixth month after treatment completion
measure: Kinesiophobia
timeFrame: At baseline
measure: Kinesiophobia
timeFrame: At the first month after intervention onset (after completion of the 12 treatment sessions)
measure: Kinesiophobia
timeFrame: Follow-up at the third month after treatment completion
measure: Kinesiophobia
timeFrame: Follow-up at the sixth month after treatment completion
measure: Quality of life questionnaire
timeFrame: Al baseline
measure: Quality of life questionnaire
timeFrame: At the first month after intervention onset (after completion of the 12 treatment sessions)
measure: Quality of life questionnaire
timeFrame: Follow-up at the third month after treatment completion
measure: Quality of life questionnaire
timeFrame: Follow-up at the sixth month after treatment completion
measure: Catastrophism
timeFrame: At baseline
measure: Catastrophism
timeFrame: At the first month after intervention onset (after completion of the 12 treatment sessions)
measure: Catastrophism
timeFrame: Follow-up at the third month after treatment completion
measure: Catastrophism
timeFrame: Follow-up at the sixth month after treatment completion
measure: Cortical excitation
timeFrame: At baseline
measure: Cortical excitation
timeFrame: At the first month after intervention onset (after completion of the 12 treatment sessions)
measure: Cortical excitation
timeFrame: Follow-up at the third month after treatment completion
measure: Cortical excitation
timeFrame: Follow-up at the sixth month after treatment completion
measure: Heart Rate Variability
timeFrame: At baseline
measure: Heart Rate Variability
timeFrame: At the first month after intervention onset (after completion of the 12 treatment sessions)
measure: Heart Rate Variability
timeFrame: Follow-up at the third month after treatment completion
measure: Heart Rate Variability
timeFrame: Follow-up at the sixth month after treatment completion
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: Eurpean University of Madrid
state: Madrid
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
Study officials:
affiliation: European University of Madrid.Department of Physiotherapy, Chiropody and Dance
name: Marina Castel Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
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