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Studies

Interventional Recruiting

NCT05757609 on ClinicalTrials.gov

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

Official title: Innovative Non-invasive Brain Stimulation in the Rehabilitation of Patients With Chronic Low Back Pain

  • Sponsor: Stephane ARMAND
  • Collaborators: La Tour Hospital, School of Health Sciences Geneva
  • Enrollment: 48 (Estimated)
  • Study start: 2023-08-21 (Actual)
  • Primary completion: 2026-10-01 (Estimated)
  • Study completion: 2026-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Chronic Low Back Pain

Intervention / Treatment

  • Device: Anodal tDCS combined with active physiotherapy
  • Device: Sham anodal tDCS combined with active physiotherapy

Primary Outcome Measures

  • Core Outcome Measures Index (COMI) (Change from baseline (T0) to immediately after the treatment period (T1))
    The Core Outcome Measures Index (COMI) comprises a short set of questions used to assess the impact of spinal disorders on multiple patient-orientated outcome domains. It is based on a set of individual items selected from established questionnaires and recommended for standardized use by an international group of experts in the field. It consists of seven items to assess the extent of the patient's back pain and leg pain, difficulties with functioning in everyday life, symptom-specific well-being, general quality of life, and social and work disability. A summary index score from 0 (best health status) to 10 (worst health status) can be computed by averaging the values of the five subscales. Scoring is done by completing one trial. Continuous measure, lower values indicate better outcome.

Countries

Switzerland

Locations and Investigators

  • University Hospitals Geneva, Geneva, Switzerland (Recruiting)
    • Thomas Pourchet, Msc

Study Officials

  • Stéphane Armand, Pr (Principal Investigator) — University Hospital, Geneva