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Transcranial Stimulation for Physiotherapy Optimisation - Chronic Low Back Pain (STOP-CLBP)

RecruitingNot applicableNCT05757609
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The main objective of this study is to investigate the effects of non-invasive brain stimulation (the so-called transcranial direct current stimulation ; tDCS) combined with an active physiotherapy program on the multidimensional impact of pain in patients with Chronic Low Back Pain (CLBP). The secondary objectives are to compare the effects of these interventions on fear of movement, psycho-emotional state, function, functional connectivity of the left dorsolaterla prefrontal cortex (DLPFC) and erector spinae activity. Participants will perform: * 2 sessions including clinical assessments including questionnaires, brain activity assessment (with EEG), and back muscle activity assessment (with EMG) * 9 interventional sessions of active physiotherapy combined with active or sham tDCS during 3 weeks (3 per week). Investigators will compare active tDCS with sham tDCS (non active) to evaluate if active tDCS is more effective than sham tDCS.

Study details

Official title
Innovative Non-invasive Brain Stimulation in the Rehabilitation of Patients With Chronic Low Back Pain
Interventions
  • Device: Anodal tDCS combined with active physiotherapy
  • Device: Sham anodal tDCS combined with active physiotherapy
Sponsor
Stephane ARMAND
Collaborators
La Tour Hospital; School of Health Sciences Geneva
Organization
University Hospital, Geneva
Start date
2023-08-21
Primary completion
2026-10
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Switzerland
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05757609