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

December 15, 2023 updated by: Stephane ARMAND

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Previous studies showed that transcranial Direct Current Stimulation (tDCS) targeting specific brain areas may offer novel treatment options in patients with chronic pain, in particular in chronic lower back pain (CLBP). Numerous tDCS trials have shown no evidence of moderate or severe adverse effects, highlighting tDCS as a safe, adequate tolerability and acceptability medical device.

However, several major limits remain before the investigators can start to design larger scale trials and more widespread clinical applications: the lack of knowledge on which brain region to target and about how neural activity is influenced by tDCS in this specific patient's population.

In consequence, the investigators do not know which setup of tDCS they can propose to CLBP patients. For instance, if the investigators manipulate brain interactions at the "wrong" tDCS setting, this may result in limited or no improvement of clinical deficits. Most existing randomized controlled trials (RCT) on tDCS treatment indeed show highly mixed effects which are likely due to incomplete understanding of tDCS-induced changes in brain and behavior. In addition, the majority of RCT have applied tDCS over the primary motor cortex (M1). Furthermore, the targeting of this brain region has recently been questioned and the dorsolateral prefrontal cortex (DLPFC) have been suggested as a valuable alternative. Knowing the mechanisms of action of tDCS based on the new rationale (i.e., tDCS targeting DLPFC) would allow us to define setup which are more likely to succeed.

The primary objective of this study is to investigate the effects of repeated sessions of tDCS combined with active physiotherapy on the multidimensional impact of pain at the end of the intervention compared to sham tDCS with active physiotherapy.

The secondary objectives are to compare the effects of these interventions on fear of movement, psycho-emotional state, function, functional connectivity of the left dorsolateral prefrontal cortex (DLPFC) and erector spinae activity.

The investigators hypothesise that tDCS combined with active physiotherapy will have a greater effect at the end of the intervention and at 3 and 6 months follow-up on all outcomes compared to sham tDCS combined with active physiotherapy.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS combined with active physiotherapy

transcranial Direct Current Stimulation (tDCS) will be applied for 20 min at an intensity of 2 mA with anodal stimulation targeting the left dorsolateral prefrontal cortex (DLPFC).

This will be done during a cycling session and will be followed by a physiotherapy program including strengthening and mobilisation exercises.

It will be applied 3 times a week during 3 weeks.
Device: Anodal tDCS combined with active physiotherapy
anodal tDCS over prefrontal cortex combined with active physiotherapy
Other Names:
  • transcranial Direct Current Stimulation
  • Soterix Medical mini-CT
Sham Comparator: Sham tDCS combined with active physiotherapy

Sham transcranial Direct Current Stimulation (tDCS) will be applied for 20 min and this induces similar sensations for the patients, but no change in excitability.

This will be done during a cycling session and will be followed by a physiotherapy programme including strengthening and mobilisation exercises.

It will be applied 3 times a week during 3 weeks.
Device: Sham anodal tDCS combined with active physiotherapy
Sham anodal tDCS over prefrontal cortex combined with active physiotherapy
Other Names:
  • Soterix Medical mini-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Outcome Measures Index (COMI)
Time Frame: 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.
Change from baseline (T0) to immediately after the treatment period (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Outcome Measures Index (COMI)
Time Frame: Change from baseline (T0) to three months (T2) and six months after the inclusion (T3)

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.
Change from baseline (T0) to three months (T2) and six months after the inclusion (T3)
Numerical Pain Rating Scale
Time Frame: Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)

Numerical Pain Rating Scale assesses the level of pain on a range from 0 to 10, with 0 being no pain and 10 being the maximum possible pain. For a clinically relevant difference to exist, there has to be a difference between measurements of at least 2 points.

This scale has been shown to have good levels of reliability for pain measurement.

Scoring is done by completing one trial.

Continuous measure, lower values indicate better outcome.
Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)
Change from Oswestry Disability Index (ODI)
Time Frame: Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)

Oswestry Disability Index (ODI) will be used to analyze the quality of life in people with low back pain. This instrument contains in 10 items that assess the impact of low back pain on several functional activities. Values range from 0 to 5, the highest value indicating greater disability. The end result is the sum of all items.

Scoring is done by completing one trial.

Continuous measure, lower values indicate better outcome.
Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)
Fear Avoidance Beliefs Questionnaire (FABQ)
Time Frame: Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)

Consists of 16 items a self-report questionnaire based on evaluation on the Fear-avoidance model.The maximum score is 96, that representing higher levels of fear-avoidance beliefs. The FABQ has two subscales: the work subscale (FABQw),and the physical activity subscale (FABQpa).

Scoring is done by completing one trial.

Continuous measure, lower values indicate better outcome
Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)
Pain Catastrophizing as assessed by the Pain Catastrophizing Scale
Time Frame: Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)

The Pain Catastrophizing Scale (PCS) is a 13 item survey assessing catastrophizing in context to pain. There are 13 items with 5-pt Likert responses.

There are several subscales. Scoring Procedure: The PCS total score is computed by summing responses to all 13 items (0-52).

Subscales:

Rumination: Sum of items 8, 9, 10, 11 (0-16). Magnification: Sum of items 6, 7, 13 (0-12). Helplessness: Sum of items 1, 2, 3, 4, 5, 12 (0-24).

Scoring is done by completing one trial.

Continuous measure, lower values indicate better outcome.
Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)
Hospital Anxiety Depression Scale (HADS)
Time Frame: Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)

A questionnaire which has also been validated and translated into French. This scale has 14 items, 7 for anxiety subscale and 7 for depression. For each item there is a score of 0 to 3, with a total of 21 points for the scale.

Scoring is done by completing one trial.

Continuous measure, lower values indicate better outcome.
Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)
Flexion Relaxation Ratio (FRR) on erector spinae
Time Frame: Change from baseline (T0) to immediately after the treatment period (T1)

Flexion-relaxation ratio is calculated by dividing muscle activity (sEMG) during trunk flexion by muscle activity during full-flexed position. sEMG of lumbar paraspinal muscles is recorder through surface electromyogramm (sEMG) during every trials of each session.

Scoring is done by completing three trials and calculating the average of the three trials to calculate the Flexion Relaxation Ratio (FRR).
Change from baseline (T0) to immediately after the treatment period (T1)
Functional connectivity from Electroencephalogram (EEG) recordings
Time Frame: Change from baseline (T0) to immediately after the treatment period (T1)

Resting state Electroencephalogram (EEG) functional connectivity (FC) analysis will be calculated.The absolute imaginary component of coherence between Dorso Lateral Prefrontal Cortex (DLPFC) (left and right) and the rest of the brain will be subsequently calculated as index of functional connectivity.

Continuous measure, higher values indicate better outcome.
Change from baseline (T0) to immediately after the treatment period (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephane ARMAND

Collaborators

La Tour Hospital
School of Health Sciences Geneva

Investigators

  • Principal Investigator: Stéphane Armand, Pr, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-D0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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