Transcranial stimulation combined with physiotherapy for chronic low back pain
Innovative Non-invasive Brain Stimulation in the Rehabilitation of Patients With Chronic Low Back Pain
This study is testing if combining a brain stimulation technique with physical therapy can help people with chronic low back pain feel better and move more freely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Geneva) |
| Trial ID | NCT05757609 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial direct current stimulation (tDCS) combined with an active physiotherapy program on patients suffering from chronic low back pain (CLBP). Participants will undergo clinical assessments and receive either active or sham tDCS during nine physiotherapy sessions over three weeks. The study aims to evaluate the effectiveness of active tDCS in improving pain, fear of movement, psycho-emotional state, and functional connectivity of the brain. By targeting the dorsolateral prefrontal cortex, the study seeks to enhance understanding of how tDCS can influence pain management in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with non-specific chronic low back pain for at least 12 weeks, experiencing moderate pain levels.
Not a fit: Patients with recent lumbar surgery, neurological disorders, or specific chronic pain syndromes 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 with chronic low back pain.
How similar studies have performed: Previous studies have shown mixed results with tDCS, but this approach targeting the dorsolateral prefrontal cortex is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ability to give informed consent, * ability to follow protocol instructions, * diagnosis of Non Specific Chronic Low Back Pain ≥12 weeks, * low back pain with or without radiation to the knee, * average pain of the previous week ≥ 3 on the VAS (Visual Analogue Scale). * have sufficient cognitive ability to fill in the various questionnaires (Level B2 French), Exclusion Criteria: * herniectomy within the last 6 months, * lumbar spinal surgery with material (e.g. prosthesis, spondylodesis), * sensory or motor deficit of a lower limb, * radiant pain in the lower limb beyond the knee, * neuropathic pain (according to the dn4 questionnaire), * diagnosis of an inflammatory rheumatic disease (e.g. rheumatoid arthritis, spondyloarthropathy), * diagnosis of a chronic generalized pain syndromee of fibromyalgia, * pregnancy, * presence of neurological or neuropsychiatric disorders, * have epilepsy or a recent or severe head injury, * metal implant in the skull (excluding fillings), * presence of a pacemaker, * unhealed wound or skin disease on the skull (electrode contact area)
Where this trial is running
Geneva
- University Hospitals Geneva — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Stéphane Armand, Pr — University Hospital, Geneva
- Study coordinator: Stéphane Armand, Pr
- Email: stephane.armand@hcuge.ch
- Phone: +41 22 372 78 23
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.