Low Back PaintDCSNCT05830851
Transcranial Direct Current Stimulation (tDCS) Combined With Aerobic Exercise in Chronic Nonspecific Low Back Pain (LBP)
A study testing real tDCS and aerobic exercise in people with Low Back Pain and Chronic Low-back Pain, run by European University of Madrid at 2 sites in Spain.
Trial summary
The goal of this clinical trial is to learn about the effects of transcranial direct current stimulation (tDCS) combined with aerobic exercise in non-specific low back pain patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Chronic Low-back Pain
- What is being tested?
- real tDCS and aerobic exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesSpain
- Study dates
- 17 Nov 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of non-specific Low Back Pain for at least 3 months based on careful radiological evaluation and clinical diagnosis by a physician.
- Aged from 18 till 65 years old.
- Scoring higher than 20mm on the 100 mm VAS scale
- Scoring higher than 4 on the Rolland-Morris scale
Who cannot join
- Any subject presenting at least one of the following exclusion criteria will be excluded from the study:
- Vertebral fractures, osteoporosis
- Infections
- Lumbar surgical, herniated disc or nerve root compression
- Rheumatologic diseases
- People with central nervous system alterations
Show all 16Show fewer
- Structured deformities of the spine (scoliosis)
- Oncology patients in active treatment or within 5 years after the end of the treatment
- Fibromyalgia
- Women who are pregnant or who may be pregnant
- Contraindications to tDCS (epilepsy, cranial implanted devices, neurological o psychiatric disorders, sever cardiopulmonary, renal or hepatic disorders)
- Being under physiotherapeutic or osteopathic treatment during the study period
- Absolute contraindications to aerobic exercise (acute myocardial infarction, unstable angina pectoris, uncontrolled arrhythmia, heart failure, acute pulmonary embolism, myocarditis or acute pericarditis)
- People who need walking assistance (cane, other person to assist)
- Patients who practise regular physical activity defined as leisure-time physical activity for 30 minutes, three or more times per week
- People unable to give informed consent, or unable to complete the selected questionnaires.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Fundación Alcorcón
Alcorcón
Alvaro Lopez Hualda
- Recruiting
Eurpean University of Madrid
Villaviciosa de Odón, Madrid, 28670
Marina Castel Sanchez, PhD, 0034679448, marina.castel@universidadeuropea.es
Dolores Sosa Reina, PhD, 0034628432666, mariadolores.sosa@universidadeuropea.es
About this study
Official title: Transcranial Direct Current Stimulation Combined With Aerobic Exercise for the Treatment of Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
The goal of this clinical trial is to learn about the effects of transcranial direct current stimulation (tDCS) combined with aerobic exercise in non-specific low back pain patients. The main question aims to answer: • Which are the effects of tDCS treatment combined with aerobic exercise compared to Sham tDCS combined with aerobic exercise in non-specific Low Back Pain? Participants will be asked to complete questionnaires and they will receive treatments as tDCS or Sham tDCS and aerobic exercise (treadmill walking). Researchers will compare a group who is treated with a combination of tDCS and aerobic exercise versus a group receiving placebo tDCS and aerobic exercise to see the effects on pain intensity, pressure pain, disability, kinesiophobia, quality of life, catastrophism, Heart Rate Variability and cortical excitation.
Read the detailed description
Low back pain (LBP) is the main cause of disability worldwide with a prevalence of 70 to 85% of the population. Chronic LBP (CLBP) is defined as a pain lasting more than 12 weeks. CLBP does not have peripheral nociceptive stimuli, but it is characterized by the presence of a chronic change in neuroplasticity. Transcranial direct current stimulation (tDCS) is a type of therapeutic intervention that can modulate the cortical excitability of a wide neural network involved in the elaboration of pain, resulting in an efficacy option for CLBP treatment. Aerobic exercise represents another typology of effective therapeutic intervention in the treatment of pain intensity and disability related to CLBP.
The main objective of the study is to determine the efficacy of tDCS combined with aerobic exercise compared to shame/placebo tDCS combined with aerobic exercise in middle-aged subjects with non-specific CLBP in the short, medium and long term.
Methods: In a double-blinded pilot randomized controlled trial, 38 subjects aged between 18 and 65 years, with a diagnose of non-specific LBP for 3 months, a Visual Analogue Scale (VAS) result of >20mm and a Roland-Morris Scale result of >4 will be selected for the following study. Participants will be divided in two groups of 19 subjects each one: experimental group A (20 minutes of tDCS at 2 mili Amper + 20-30 minutes of aerobic exercise at 60-80% of HRmax) and controlled group B (30 seconds of sham/placebo tDCS at 2milli amperes + 20-30 minutes of aerobic exercise at 60-80% of maximum heart rate). The following outcomes will be measured: pain intensity (100mm VAS), pressure pain (pressure algometer), disability (Roland-Morris questionnaire), kinesiophobia (Tampa Scale for kinesiophobia), quality of life (SF-12 health questionnaire), catastrophism (Pain Catastrophizing Scale), Heart Rate Variability ( Polar Team) and cortical excitation (Critical Flicker Fusion).
- Conditions
- Low Back Pain, Chronic Low-back Pain
- Being tested
- real tDCS and aerobic exercise, sham tDCS and aerobic exercise
- Keywords
- low back pain, chronic low back pain, non-specific chronic low back pain, transcranial direct current stimulation, tDCS, aerobic exercise, aerobic training, walking
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real tDCS and aerobic exerciseOther
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters
sham tDCS and aerobic exerciseOther
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise | Active comparator | Walk on a treadmill during 20-30 minutes at 60-80% of Heart Rate max Receives: Other: real tDCS and aerobic exercise; Other: sham tDCS and aerobic exercise |
| Sham tDCS | Sham comparator | Application of tDCS during 30 seconds of 2 mA-intensity. Receives: Other: sham tDCS and aerobic exercise |
| real tDCS | Experimental | Application of real tDCS during 20 minutes at 2 mili Amper (mA)-intensity. Receives: Other: real tDCS and aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured with Visual Analogue Scale of 100 mm
Measured: At baseline
Pain intensity
Measured with Visual Analogue Scale of 100 mm
Measured: At the first month after intervention onset (after completion of the 12 treatment sessions).
Pain intensity
Measured with Visual Analogue Scale of 100 mm
Measured: Follow-up at the third month after treatment completion
Pain intensity
Measured with Visual Analogue Scale of 100 mm
Measured: Follow-up at the sixth month after treatment completion
Pressure pain
Measured with a pressure algometer
Measured: At baseline
Pressure pain
Measured with a pressure algometer
Measured: At the first month after intervention onset (after completion of the 12 treatment sessions).
Pressure pain
Measured with a pressure algometer
Measured: Follow-up at the third month after treatment completion
Pressure pain
Measured with a pressure algometer
Measured: Follow-up at the sixth month after treatment completion
Secondary outcomes (24)
Disability
Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)
Measured: At baseline
Disability
Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)
Measured: At the first month after intervention onset (after completion of the 12 treatment sessions).
Disability
Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)
Measured: Follow-up at the third month after treatment completion
Disability
Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)
Measured: Follow-up at the sixth month after treatment completion
Kinesiophobia
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
Measured: At baseline
Kinesiophobia
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
Measured: At the first month after intervention onset (after completion of the 12 treatment sessions)
Kinesiophobia
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
Measured: Follow-up at the third month after treatment completion
Kinesiophobia
Measured with Tampa Kinesiophobia Scale questionnaire (TSK-11SV) Spanish version. Minimum and maximum values are between 11 and 44 point, a result with higher values indicates higher level of kinesiofobia.
Measured: Follow-up at the sixth month after treatment completion
Quality of life questionnaire
Measured with SF-12 Health Questionnaire Spanish version. A zero score indicates the lowest level of dimension measured by the scale, and 100 indicates the highest level of the measured dimension
Measured: Al baseline
Quality of life questionnaire
Measured with SF-12 Health Questionnaire Spanish version. A zero score indicates the lowest level of dimension measured by the scale, and 100 indicates the highest level of the measured dimension
Measured: At the first month after intervention onset (after completion of the 12 treatment sessions)
Quality of life questionnaire
Measured with SF-12 Health Questionnaire Spanish version. A zero score indicates the lowest level of dimension measured by the scale, and 100 indicates the highest level of the measured dimension
Measured: Follow-up at the third month after treatment completion
Quality of life questionnaire
Measured with SF-12 Health Questionnaire Spanish version. A zero score indicates the lowest level of dimension measured by the scale, and 100 indicates the highest level of the measured dimension
Measured: Follow-up at the sixth month after treatment completion
Catastrophism
Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.
Measured: At baseline
Catastrophism
Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.
Measured: At the first month after intervention onset (after completion of the 12 treatment sessions)
Catastrophism
Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.
Measured: Follow-up at the third month after treatment completion
Catastrophism
Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.
Measured: Follow-up at the sixth month after treatment completion
Cortical excitation
Measured with Critical Flicker Fusion Threshold
Measured: At baseline
Cortical excitation
Measured with Critical Flicker Fusion Threshold
Measured: At the first month after intervention onset (after completion of the 12 treatment sessions)
Cortical excitation
Measured with Critical Flicker Fusion Threshold
Measured: Follow-up at the third month after treatment completion
Cortical excitation
Measured with Critical Flicker Fusion Threshold
Measured: Follow-up at the sixth month after treatment completion
Heart Rate Variability
Measured with Polar Heart Rate belt
Measured: At baseline
Heart Rate Variability
Measured with Polar Heart Rate belt
Measured: At the first month after intervention onset (after completion of the 12 treatment sessions)
Heart Rate Variability
Measured with Polar Heart Rate belt
Measured: Follow-up at the third month after treatment completion
Heart Rate Variability
Measured with Polar Heart Rate belt
Measured: Follow-up at the sixth month after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start17 Nov 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (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 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Castel Sánchez, European University of Madrid
- Investigators
- Marina Castel Sánchez, PhD, Principal investigator, European University of Madrid.Department of Physiotherapy, Chiropody and Dance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830851
- Sponsor's protocol ID
- tDCS&aeorbic excercise in LBP
- Acronym
- tDCS
- Status last verified
- Sep 2023
- First submitted
- 31 Mar 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32647923Wong CK, Mak RY, Kwok TS, Tsang JS, Leung MY, Funabashi M, Macedo LG, Dennett L, Wong AY. Prevalence, Incidence, and Factors Associated With Non-Specific Chronic Low Back Pain in Community-Dwelling Older Adults Aged 60 Years and Older: A Systematic Review and Meta-Analysis. J Pain. 2022 Apr;23(4):509-534. doi: 10.1016/j.jpain.2021.07.012. Epub 2021 Aug 24.
PubMed 34450274Pergolizzi JV Jr, LeQuang JA. Rehabilitation for Low Back Pain: A Narrative Review for Managing Pain and Improving Function in Acute and Chronic Conditions. Pain Ther. 2020 Jun;9(1):83-96. doi: 10.1007/s40122-020-00149-5. Epub 2020 Jan 31.
PubMed 32006236Tornero Aguilera JF, Fernandez Elias V, Clemente-Suarez VJ. Autonomic and cortical response of soldiers in different combat scenarios. BMJ Mil Health. 2021 Jun;167(3):172-176. doi: 10.1136/jramc-2019-001285. Epub 2020 Feb 27.
PubMed 32111675Cavalcante PGL, Baptista AF, Cardoso VS, Filgueiras MC, Hasue RH, Joao SMA, Hazime FA. Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial. Phys Ther. 2020 Aug 31;100(9):1595-1602. doi: 10.1093/ptj/pzaa105.
PubMed 32526017Ouellette AL, Liston MB, Chang WJ, Walton DM, Wand BM, Schabrun SM. Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial. BMJ Open. 2017 Aug 21;7(8):e013080. doi: 10.1136/bmjopen-2016-013080.
PubMed 28827229Pinto 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 29952860DosSantos MF, Ferreira N, Toback RL, Carvalho AC, DaSilva AF. Potential Mechanisms Supporting the Value of Motor Cortex Stimulation to Treat Chronic Pain Syndromes. Front Neurosci. 2016 Feb 11;10:18. doi: 10.3389/fnins.2016.00018. eCollection 2016.
PubMed 26903788Pacheco-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 32845195Bruehl S, Burns JW, Koltyn K, Gupta R, Buvanendran A, Edwards D, Chont M, Wu YH, Qu'd D, Stone A. Are endogenous opioid mechanisms involved in the effects of aerobic exercise training on chronic low back pain? A randomized controlled trial. Pain. 2020 Dec;161(12):2887-2897. doi: 10.1097/j.pain.0000000000001969.
PubMed 32569082O'Connor SR, Tully MA, Ryan B, Bleakley CM, Baxter GD, Bradley JM, McDonough SM. Walking exercise for chronic musculoskeletal pain: systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 Apr;96(4):724-734.e3. doi: 10.1016/j.apmr.2014.12.003. Epub 2014 Dec 19.
PubMed 25529265
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Combined With Aerobic Exercise for the Treatment of Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05830851
- Acronym / sponsor ID
- tDCS / tDCS&aeorbic excercise in LBP
- Conditions
- Low Back Pain, Chronic Low-back Pain
- Keywords
- low back pain, chronic low back pain, non-specific chronic low back pain, transcranial direct current stimulation, tDCS, aerobic exercise, aerobic training, walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- European University of MadridUniversity, hospital or other
- Study start
- 17 Nov 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 26 Apr 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 goal of this clinical trial is to learn about the effects of transcranial direct current stimulation (tDCS) combined with aerobic exercise in non-specific low back pain patients. The main question aims to answer: • Which are the effects of tDCS treatment combined with aerobic exercise compared to Sham tDCS combined with aerobic exercise in non-specific Low Back Pain? Participants will be asked to complete questionnaires and they will receive treatments as tDCS or Sham tDCS and aerobic exercise (treadmill walking). Researchers will compare a group who is treated with a combination of tDCS and aerobic exercise versus a group receiving placebo tDCS and aerobic exercise to see the effects on pain intensity, pressure pain, disability, kinesiophobia, quality of life, catastrophism, Heart Rate Variability and cortical excitation.
Detailed description
Low back pain (LBP) is the main cause of disability worldwide with a prevalence of 70 to 85% of the population. Chronic LBP (CLBP) is defined as a pain lasting more than 12 weeks. CLBP does not have peripheral nociceptive stimuli, but it is characterized by the presence of a chronic change in neuroplasticity. Transcranial direct current stimulation (tDCS) is a type of therapeutic intervention that can modulate the cortical excitability of a wide neural network involved in the elaboration of pain, resulting in an efficacy option for CLBP treatment. Aerobic exercise represents another typology of effective therapeutic intervention in the treatment of pain intensity and disability related to CLBP.
The main objective of the study is to determine the efficacy of tDCS combined with aerobic exercise compared to shame/placebo tDCS combined with aerobic exercise in middle-aged subjects with non-specific CLBP in the short, medium and long term.
Methods: In a double-blinded pilot randomized controlled trial, 38 subjects aged between 18 and 65 years, with a diagnose of non-specific LBP for 3 months, a Visual Analogue Scale (VAS) result of >20mm and a Roland-Morris Scale result of >4 will be selected for the following study. Participants will be divided in two groups of 19 subjects each one: experimental group A (20 minutes of tDCS at 2 mili Amper + 20-30 minutes of aerobic exercise at 60-80% of HRmax) and controlled group B (30 seconds of sham/placebo tDCS at 2milli amperes + 20-30 minutes of aerobic exercise at 60-80% of maximum heart rate). The following outcomes will be measured: pain intensity (100mm VAS), pressure pain (pressure algometer), disability (Roland-Morris questionnaire), kinesiophobia (Tampa Scale for kinesiophobia), quality of life (SF-12 health questionnaire), catastrophism (Pain Catastrophizing Scale), Heart Rate Variability ( Polar Team) and cortical excitation (Critical Flicker Fusion).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | Active comparator | Other: real tDCS and aerobic exercise, Other: sham tDCS and aerobic exerciseWalk on a treadmill during 20-30 minutes at 60-80% of Heart Rate max |
| Sham tDCS | Sham comparator | Other: sham tDCS and aerobic exerciseApplication of tDCS during 30 seconds of 2 mA-intensity. |
| real tDCS | Experimental | Other: real tDCS and aerobic exerciseApplication of real tDCS during 20 minutes at 2 mili Amper (mA)-intensity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of non-specific Low Back Pain for at least 3 months based on careful radiological evaluation and clinical diagnosis by a physician.
- Aged from 18 till 65 years old.
- Scoring higher than 20mm on the 100 mm VAS scale
- Scoring higher than 4 on the Rolland-Morris scale
Key exclusion criteria (16 listed)
- Any subject presenting at least one of the following exclusion criteria will be excluded from the study:
- Vertebral fractures, osteoporosis
- Infections
- Lumbar surgical, herniated disc or nerve root compression
- Rheumatologic diseases
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 |
|---|---|---|
| real tDCS and aerobic exerciseWalking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters | Other | aerobic exercise, real tDCS |
| sham tDCS and aerobic exerciseWalking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with sham tDCS | Other | Sham tDCS, aerobic exercise |
Primary outcome
Pain intensity
Time frame: At baseline
Measured with Visual Analogue Scale of 100 mm
Pain intensity
Time frame: At the first month after intervention onset (after completion of the 12 treatment sessions).
Measured with Visual Analogue Scale of 100 mm
Pain intensity
Time frame: Follow-up at the third month after treatment completion
Measured with Visual Analogue Scale of 100 mm
Pain intensity
Time frame: Follow-up at the sixth month after treatment completion
Measured with Visual Analogue Scale of 100 mm
Pressure pain
Time frame: At baseline
Measured with a pressure algometer
Pressure pain
Time frame: At the first month after intervention onset (after completion of the 12 treatment sessions).
Measured with a pressure algometer
Pressure pain
Time frame: Follow-up at the third month after treatment completion
Measured with a pressure algometer
Pressure pain
Time frame: Follow-up at the sixth month after treatment completion
Measured with a pressure algometer
24 secondary outcomes
Disability
Time frame: At baseline
Disability
Time frame: At the first month after intervention onset (after completion of the 12 treatment sessions).
Disability
Time frame: Follow-up at the third month after treatment completion
Disability
Time frame: Follow-up at the sixth month after treatment completion
Kinesiophobia
Time frame: At baseline
Kinesiophobia
Time frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Kinesiophobia
Time frame: Follow-up at the third month after treatment completion
Kinesiophobia
Time frame: Follow-up at the sixth month after treatment completion
Quality of life questionnaire
Time frame: Al baseline
Quality of life questionnaire
Time frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Quality of life questionnaire
Time frame: Follow-up at the third month after treatment completion
Quality of life questionnaire
Time frame: Follow-up at the sixth month after treatment completion
Catastrophism
Time frame: At baseline
Catastrophism
Time frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Catastrophism
Time frame: Follow-up at the third month after treatment completion
Catastrophism
Time frame: Follow-up at the sixth month after treatment completion
Cortical excitation
Time frame: At baseline
Cortical excitation
Time frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Cortical excitation
Time frame: Follow-up at the third month after treatment completion
Cortical excitation
Time frame: Follow-up at the sixth month after treatment completion
Heart Rate Variability
Time frame: At baseline
Heart Rate Variability
Time frame: At the first month after intervention onset (after completion of the 12 treatment sessions)
Heart Rate Variability
Time frame: Follow-up at the third month after treatment completion
Heart Rate Variability
Time frame: Follow-up at the sixth month after treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- 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 34450274Wong CK, Mak RY, Kwok TS, Tsang JS, Leung MY, Funabashi M, Macedo LG, Dennett L, Wong AY. Prevalence, Incidence, and Factors Associated With Non-Specific Chronic Low Back Pain in Community-Dwelling Older Adults Aged 60 Years and Older: A Systematic Review and Meta-Analysis. J Pain. 2022 Apr;23(4):509-534. doi: 10.1016/j.jpain.2021.07.012. Epub 2021 Aug 24.
- Background: PubMed 32006236Pergolizzi JV Jr, LeQuang JA. Rehabilitation for Low Back Pain: A Narrative Review for Managing Pain and Improving Function in Acute and Chronic Conditions. Pain Ther. 2020 Jun;9(1):83-96. doi: 10.1007/s40122-020-00149-5. Epub 2020 Jan 31.
- Background: PubMed 32111675Tornero Aguilera JF, Fernandez Elias V, Clemente-Suarez VJ. Autonomic and cortical response of soldiers in different combat scenarios. BMJ Mil Health. 2021 Jun;167(3):172-176. doi: 10.1136/jramc-2019-001285. Epub 2020 Feb 27.
- Background: PubMed 32526017Cavalcante PGL, Baptista AF, Cardoso VS, Filgueiras MC, Hasue RH, Joao SMA, Hazime FA. Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial. Phys Ther. 2020 Aug 31;100(9):1595-1602. doi: 10.1093/ptj/pzaa105.
- Background: PubMed 28827229Ouellette AL, Liston MB, Chang WJ, Walton DM, Wand BM, Schabrun SM. Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial. BMJ Open. 2017 Aug 21;7(8):e013080. doi: 10.1136/bmjopen-2016-013080.
- 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 26903788DosSantos MF, Ferreira N, Toback RL, Carvalho AC, DaSilva AF. Potential Mechanisms Supporting the Value of Motor Cortex Stimulation to Treat Chronic Pain Syndromes. Front Neurosci. 2016 Feb 11;10:18. doi: 10.3389/fnins.2016.00018. eCollection 2016.
- 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.
- Background: PubMed 32569082Bruehl S, Burns JW, Koltyn K, Gupta R, Buvanendran A, Edwards D, Chont M, Wu YH, Qu'd D, Stone A. Are endogenous opioid mechanisms involved in the effects of aerobic exercise training on chronic low back pain? A randomized controlled trial. Pain. 2020 Dec;161(12):2887-2897. doi: 10.1097/j.pain.0000000000001969.
- Background: PubMed 25529265O'Connor SR, Tully MA, Ryan B, Bleakley CM, Baxter GD, Bradley JM, McDonough SM. Walking exercise for chronic musculoskeletal pain: systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 Apr;96(4):724-734.e3. doi: 10.1016/j.apmr.2014.12.003. Epub 2014 Dec 19.
- 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. This study is not recruiting at the moment.
Marina Castel Sánchez, PhD principal investigator
European University of Madrid.Department of Physiotherapy, Chiropody and Dance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real tDCS and aerobic exercise in people with Low Back Pain and Chronic Low-back Pain, run by European University of Madrid at 2 sites in Spain.
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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Castel- Sánchez, PhD (0034-679448994, marina.castel@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At baseline). The study lists 8 primary outcomes in all. 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 NCT05830851, 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 8 Sep 2023.