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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Core Outcome Measures Index (COMI) [Time frame: Change from baseline (T0) to immediately after the treatment period (T1)]

Secondary outcome measures (8)

• Core Outcome Measures Index (COMI) [Time frame: 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• Flexion Relaxation Ratio (FRR) on erector spinae [Time frame: 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• University Hospitals Geneva — Geneva

Publications

• 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. PMID 34062145
• 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. PMID 36533133
• 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. PMID 29952860
• 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. PMID 32647923
• 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. PMID 34531819
• 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. PMID 23189136
• 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. PMID 23221623
• 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. PMID 25636503

Identifiers

NCT: NCT05757609 · 2022-D0077

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗