Chronic Low Back PainSTOP-CLBPNCT05757609
Transcranial Stimulation for Physiotherapy Optimisation - Chronic Low Back Pain (STOP-CLBP)
A study testing Anodal tDCS combined with active physiotherapy in people with Chronic Low Back Pain, run by Stephane ARMAND at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Anodal tDCS combined with active physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Aug 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Who cannot join
- 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),
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospitals Geneva
Geneva, 1205
Thomas Pourchet, Msc, +41 22 558 66 83, thomas.pourchet@hesge.ch
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Anodal tDCS combined with active physiotherapy, Sham anodal tDCS combined with active physiotherapy
- Keywords
- tDCS, Physiotherapy, Flexion relaxation Phenomenon, prefrontal cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCS combined with active physiotherapyDevice
Also called transcranial Direct Current Stimulation, Soterix Medical mini-CT
anodal tDCS over prefrontal cortex combined with active physiotherapy
Sham anodal tDCS combined with active physiotherapyDevice
Also called Soterix Medical mini-CT
Sham anodal tDCS over prefrontal cortex combined with active physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham anodal tDCS combined with active physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (T0) to immediately after the treatment period (T1)
Secondary outcomes (8)
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.
Measured: Change from baseline (T0) to three months (T2) and six months after the inclusion (T3)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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).
Measured: Change from baseline (T0) to immediately after the treatment period (T1)
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.
Measured: Change from baseline (T0) to immediately after the treatment period (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start21 Aug 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephane ARMAND
- Sponsor type
- University, hospital or other
- Collaborators
- La Tour Hospital, School of Health Sciences Geneva
- Responsible party
- Sponsor-investigator, Stephane ARMAND, University Hospital, Geneva
- Investigators
- Stéphane Armand, Pr, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757609
- Sponsor's protocol ID
- 2022-D0077
- Acronym
- STOP-CLBP
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34062145Wen 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.
PubMed 36533133Pinto 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.
PubMed 29952860Alwardat 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.
PubMed 32647923Kandic 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.
PubMed 34531819Luedtke 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.
PubMed 23189136O'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.
PubMed 23221623Hazime 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.
PubMed 25636503Straudi 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.
PubMed 29783893Pacheco-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.
PubMed 32845195Pourchet T, Armand S, Martins C, Barrue-Belou S, Genevay S, Nicolo P. Transcranial direct current stimulation (tDCS) over the dorso-lateral-prefrontal cortex in combination with exercises for the treatment of individuals with chronic low back pain (STOP-Low Back Pain Trial): study protocol for a randomised controlled trial. BMJ Open. 2026 Mar 18;16(3):e111649. doi: 10.1136/bmjopen-2025-111649.
PubMed 41857826
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Non-invasive Brain Stimulation in the Rehabilitation of Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05757609
- Acronym / sponsor ID
- STOP-CLBP / 2022-D0077
- Conditions
- Chronic Low Back Pain
- Keywords
- tDCS, Physiotherapy, Flexion relaxation Phenomenon, prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Stephane ARMANDUniversity, hospital or other
- Collaborators
- La Tour Hospital, School of Health Sciences Geneva
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS combined with active physiotherapy | Experimental | Device: Anodal tDCS combined with active physiotherapytranscranial 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. |
| Sham tDCS combined with active physiotherapy | Sham comparator | Device: Sham anodal tDCS combined with active physiotherapySham 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCS combined with active physiotherapyAlso: transcranial Direct Current Stimulation, Soterix Medical mini-CTanodal tDCS over prefrontal cortex combined with active physiotherapy | Device | tDCS combined with active physiotherapy |
| Sham anodal tDCS combined with active physiotherapyAlso: Soterix Medical mini-CTSham anodal tDCS over prefrontal cortex combined with active physiotherapy | Device | Sham tDCS combined with active physiotherapy |
Primary outcome
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.
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Background: PubMed 34062145Knotkova 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.
- Background: PubMed 36533133Wen 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.
- Background: PubMed 29952860Pinto 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.
- Background: PubMed 32647923Alwardat 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.
- Background: PubMed 34531819Kandic 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.
- Background: PubMed 23189136Luedtke 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.
- Background: PubMed 23221623O'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.
- Background: PubMed 25636503Hazime 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.
- Background: PubMed 29783893Straudi 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.
- Background: PubMed 32845195Pacheco-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.
- Derived from this study: PubMed 41857826Pourchet T, Armand S, Martins C, Barrue-Belou S, Genevay S, Nicolo P. Transcranial direct current stimulation (tDCS) over the dorso-lateral-prefrontal cortex in combination with exercises for the treatment of individuals with chronic low back pain (STOP-Low Back Pain Trial): study protocol for a randomised controlled trial. BMJ Open. 2026 Mar 18;16(3):e111649. doi: 10.1136/bmjopen-2025-111649.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane Armand, Pr principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS combined with active physiotherapy in people with Chronic Low Back Pain, run by Stephane ARMAND at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Armand, Pr (+41 22 372 78 23, stephane.armand@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Outcome Measures Index (COMI) (time frame: Change from baseline (T0) to immediately after the treatment period (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05757609, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.