Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05757609

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

Led by Stephane ARMAND · Updated on 2023-12-18

48

Participants Needed

1

Research Sites

171 weeks

Total Duration

On this page

Sponsors

S

Stephane ARMAND

Lead Sponsor

L

La Tour Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to give informed consent
  • Ability to follow study instructions
  • Diagnosis of non-specific chronic low back pain lasting 12 weeks or more
  • Low back pain with or without pain radiating to the knee
  • Average pain in the past week of 3 or higher on the Visual Analogue Scale
  • Sufficient cognitive ability to complete questionnaires in French (Level B2)
Not Eligible

You will not qualify if you...

  • Herniectomy within the last 6 months
  • Lumbar spinal surgery with implanted material such as prosthesis or spondylodesis
  • Sensory or motor deficit in a lower limb
  • Radiant pain in the lower limb beyond the knee
  • Neuropathic pain based on the DN4 questionnaire
  • Diagnosis of inflammatory rheumatic diseases like rheumatoid arthritis or spondyloarthropathy
  • Diagnosis of chronic generalized pain syndromes such as fibromyalgia
  • Pregnancy
  • Presence of neurological or neuropsychiatric disorders
  • Epilepsy or recent/severe head injury
  • Metal implant in the skull, excluding dental fillings
  • Presence of a pacemaker
  • Unhealed wounds or skin disease on the skull where electrodes would be placed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University Hospitals Geneva

Geneva, Switzerland, 1205

Actively Recruiting

Loading map...

Research Team

S

Stéphane Armand, Pr

CONTACT

T

Thomas Pourchet, PT, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here