Transcranial Stimulation for Physiotherapy Optimisation - Chronic Low Back Pain (STOP-CLBP)
NCT ID: NCT05757609
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2023-08-21
2026-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Anodal tDCS combined with active physiotherapy
anodal tDCS over prefrontal cortex combined with active physiotherapy
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.
Sham anodal tDCS combined with active physiotherapy
Sham anodal tDCS over prefrontal cortex combined with active physiotherapy
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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La Tour Hospital
OTHER
School of Health Sciences Geneva
OTHER
Stephane ARMAND
OTHER
Responsible Party
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Stephane ARMAND
professor
Principal Investigators
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Stéphane Armand, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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University Hospitals Geneva
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Thomas Pourchet, Msc
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2022-D0077
Identifier Type: -
Identifier Source: org_study_id