Chronic Low-back Pain, Low Back Pain
Conditions
Keywords
low back pain, chronic low back pain, non-specific chronic low back pain, transcranial direct current stimulation, tDCS, aerobic exercise, aerobic training, walking
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).
Interventions
OTHERreal tDCS and aerobic exercise
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters
OTHERsham tDCS and aerobic exercise
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with sham tDCS
Sponsors
European University of Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | At baseline | Measured with Visual Analogue Scale of 100 mm |
| Pressure pain | At baseline | Measured with a pressure algometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Disability | At baseline | Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability) |
| Heart Rate Variability | At baseline | Measured with Polar Heart Rate belt |
| Cortical excitation | At baseline | Measured with Critical Flicker Fusion Threshold |
| 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. |
Countries
Spain
Contacts
Primary ContactMarina Castel- Sánchez, PhD
Backup ContactDolores Sosa- Reina, PhD
Outcome results
None listed