Combining brain stimulation with exercise for chronic low back pain relief
Transcranial Direct Current Stimulation Combined With Aerobic Exercise for the Treatment of Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
NA · European University of Madrid · NCT05830851
This study is testing if combining brain stimulation with exercise can help people with chronic low back pain feel better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | European University of Madrid (other) |
| Locations | 2 sites (Villaviciosa De Odón, Madrid and 1 other locations) |
| Trial ID | NCT05830851 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of transcranial direct current stimulation (tDCS) combined with aerobic exercise on patients suffering from non-specific chronic low back pain (CLBP). Participants will be randomly assigned to receive either real tDCS or sham tDCS alongside aerobic exercise, with their pain intensity, disability, and quality of life being assessed through questionnaires and various scales. The study aims to determine the efficacy of this combined treatment approach over short, medium, and long-term periods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of non-specific low back pain lasting more than three months.
Not a fit: Patients with specific contraindications such as vertebral fractures, infections, or central nervous system alterations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from chronic low back pain.
How similar studies have performed: While the combination of tDCS and aerobic exercise is a relatively novel approach, previous studies have shown promise in using tDCS for pain management.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Villaviciosa De Odón, Madrid and 1 other locations
- Eurpean University of Madrid — Villaviciosa De Odón, Madrid, Spain (RECRUITING)
- Hospital Universitario Fundación Alcorcón — Alcorcón, Spain (RECRUITING)
Study contacts
- Principal investigator: Marina Castel Sánchez, PhD — European University of Madrid.Department of Physiotherapy, Chiropody and Dance
- Study coordinator: Marina Castel- Sánchez, PhD
- Email: marina.castel@universidadeuropea.es
- Phone: 0034-679448994
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Low Back Pain, Chronic Low-back Pain, low back pain, chronic low back pain, non-specific chronic low back pain, transcranial direct current stimulation, tDCS, aerobic exercise