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

NCT05757609 | Recruiting

• 1 other identifier: 2022-D0077
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low Back Pain

Keywords

tDCS; Physiotherapy; Flexion relaxation Phenomenon; prefrontal cortex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Core Outcome Measures Index (COMI)

  Change from baseline (T0) to three months (T2) and six months after the inclusion (T3)

• Numerical Pain Rating Scale

  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)

  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)

  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

  Change from baseline (T0) to immediately after the treatment period (T1) and three months (T2) and six months after the inclusion (T3)

Study Arms (2)

tDCS combined with active physiotherapy

EXPERIMENTAL

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

Sham tDCS combined with active physiotherapy

SHAM COMPARATOR

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

Interventions

Anodal tDCS combined with active physiotherapy DEVICE

anodal tDCS over prefrontal cortex combined with active physiotherapy

Also known as: transcranial Direct Current Stimulation, Soterix Medical mini-CT

tDCS combined with active physiotherapy

Sham anodal tDCS combined with active physiotherapy DEVICE

Sham anodal tDCS over prefrontal cortex combined with active physiotherapy

Also known as: Soterix Medical mini-CT

Sham tDCS combined with active physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stephane ARMAND: lead
• La Tour Hospital: collaborator
• School of Health Sciences Geneva: collaborator

Study Sites (1)

University Hospitals Geneva

Geneva, 1205, Switzerland

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 29783893 BACKGROUND

• 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.

  PMID: 32845195 BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Stéphane Armand, Pr

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane Armand, Pr

CONTACT

+41 22 372 78 23; stephane.armand@hcuge.ch

Thomas Pourchet, PT, MSc

CONTACT

+41 22 558 66 83; thomas.pourchet@hesge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statiticians will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: August 21, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)