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

Chronic Low Back Pain Clinical Trial

— STOP-CLBP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757609
• Other study ID #: 2022-D0077
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Geneva
• Contact: Stéphane Armand, Pr
• Phone: +41 22 372 78 23
• Email: stephane.armand[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Anodal tDCS combined with active physiotherapy
anodal tDCS over prefrontal cortex combined with active physiotherapy
• Sham anodal tDCS combined with active physiotherapy
Sham anodal tDCS over prefrontal cortex combined with active physiotherapy

Locations

Country	Name	City	State
Switzerland	University Hospitals Geneva	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
Stephane ARMAND	La Tour Hospital, School of Health Sciences Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (10)

Alwardat M, Pisani A, Etoom M, Carpenedo R, Chine E, Dauri M, Leonardis F, Natoli S. Is transcranial direct current stimulation (tDCS) effective for chronic low back pain? A systematic review and meta-analysis. J Neural Transm (Vienna). 2020 Sep;127(9):1257-1270. doi: 10.1007/s00702-020-02223-w. Epub 2020 Jul 9. — View Citation

Hazime FA, de Freitas DG, Monteiro RL, Maretto RL, Carvalho NA, Hasue RH, Joao SM. Analgesic efficacy of cerebral and peripheral electrical stimulation in chronic nonspecific low back pain: a randomized, double-blind, factorial clinical trial. BMC Musculoskelet Disord. 2015 Jan 31;16(1):7. doi: 10.1186/s12891-015-0461-1. — View Citation

Kandic M, Moliadze V, Andoh J, Flor H, Nees F. Brain Circuits Involved in the Development of Chronic Musculoskeletal Pain: Evidence From Non-invasive Brain Stimulation. Front Neurol. 2021 Aug 31;12:732034. doi: 10.3389/fneur.2021.732034. eCollection 2021. — View Citation

Knotkova H, Hamani C, Sivanesan E, Le Beuffe MFE, Moon JY, Cohen SP, Huntoon MA. Neuromodulation for chronic pain. Lancet. 2021 May 29;397(10289):2111-2124. doi: 10.1016/S0140-6736(21)00794-7. — View Citation

Luedtke K, May A, Jurgens TP. No effect of a single session of transcranial direct current stimulation on experimentally induced pain in patients with chronic low back pain--an exploratory study. PLoS One. 2012;7(11):e48857. doi: 10.1371/journal.pone.0048857. Epub 2012 Nov 26. — View Citation

O'Connell NE, Cossar J, Marston L, Wand BM, Bunce D, De Souza LH, Maskill DW, Sharp A, Moseley GL. Transcranial direct current stimulation of the motor cortex in the treatment of chronic nonspecific low back pain: a randomized, double-blind exploratory study. Clin J Pain. 2013 Jan;29(1):26-34. doi: 10.1097/AJP.0b013e318247ec09. — View Citation

Pacheco-Barrios K, Cardenas-Rojas A, Thibaut A, Costa B, Ferreira I, Caumo W, Fregni F. Methods and strategies of tDCS for the treatment of pain: current status and future directions. Expert Rev Med Devices. 2020 Sep;17(9):879-898. doi: 10.1080/17434440.2020.1816168. Epub 2020 Sep 15. — View Citation

Pinto CB, Teixeira Costa B, Duarte D, Fregni F. Transcranial Direct Current Stimulation as a Therapeutic Tool for Chronic Pain. J ECT. 2018 Sep;34(3):e36-e50. doi: 10.1097/YCT.0000000000000518. — View Citation

Straudi S, Buja S, Baroni A, Pavarelli C, Pranovi G, Fregni F, Basaglia N. The effects of transcranial direct current stimulation (tDCS) combined with group exercise treatment in subjects with chronic low back pain: a pilot randomized control trial. Clin Rehabil. 2018 Oct;32(10):1348-1356. doi: 10.1177/0269215518777881. Epub 2018 May 21. — View Citation

Wen YR, Shi J, Hu ZY, Lin YY, Lin YT, Jiang X, Wang R, Wang XQ, Wang YL. Is transcranial direct current stimulation beneficial for treating pain, depression, and anxiety symptoms in patients with chronic pain? A systematic review and meta-analysis. Front Mol Neurosci. 2022 Dec 1;15:1056966. doi: 10.3389/fnmol.2022.1056966. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core Outcome Measures Index (COMI)	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	Core Outcome Measures Index (COMI)	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)
Secondary	Numerical Pain Rating Scale	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)
Secondary	Change from Oswestry Disability Index (ODI)	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)
Secondary	Fear Avoidance Beliefs Questionnaire (FABQ)	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)
Secondary	Pain Catastrophizing as assessed by the Pain Catastrophizing Scale	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)
Secondary	Hospital Anxiety Depression Scale (HADS)	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)
Secondary	Flexion Relaxation Ratio (FRR) on erector spinae	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)
Secondary	Functional connectivity from Electroencephalogram (EEG) recordings	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)