Transcranial Direct Current Stimulation (tDCS) Combined With Aerobic Exercise in Chronic Nonspecific Low Back Pain (LBP)

Low Back Pain Clinical Trial

— tDCS  

Official title:

Transcranial Direct Current Stimulation Combined With Aerobic Exercise for the Treatment of Chronic Nonspecific Low Back Pain: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830851
• Other study ID #: tDCS&aeorbic excercise in LBP
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: European University of Madrid
• Contact: Marina Castel- Sánchez, PhD
• Phone: 0034-679448994
• Email: marina.castel[@]universidadeuropea.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

• 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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• real tDCS and aerobic exercise
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters
• sham tDCS and aerobic exercise
Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with sham tDCS

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón
Spain	Eurpean University of Madrid	Villaviciosa De Odón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
European University of Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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. — View Citation

Bruehl 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. — View Citation

Cavalcante 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. — View Citation

DosSantos 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. — View Citation

O'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. Erratum In: Arch Phys Med Rehabil. 2015 Jun;96(6):1182. — View Citation

Ouellette 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. — View Citation

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. — View Citation

Pergolizzi 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. — View Citation

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. — View Citation

Tornero 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. — View Citation

Wong 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Measured with Visual Analogue Scale of 100 mm	At baseline
Primary	Pain intensity	Measured with Visual Analogue Scale of 100 mm	At the first month after intervention onset (after completion of the 12 treatment sessions).
Primary	Pain intensity	Measured with Visual Analogue Scale of 100 mm	Follow-up at the third month after treatment completion
Primary	Pain intensity	Measured with Visual Analogue Scale of 100 mm	Follow-up at the sixth month after treatment completion
Primary	Pressure pain	Measured with a pressure algometer	At baseline
Primary	Pressure pain	Measured with a pressure algometer	At the first month after intervention onset (after completion of the 12 treatment sessions).
Primary	Pressure pain	Measured with a pressure algometer	Follow-up at the third month after treatment completion
Primary	Pressure pain	Measured with a pressure algometer	Follow-up at the sixth month after treatment completion
Secondary	Disability	Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)	At baseline
Secondary	Disability	Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)	At the first month after intervention onset (after completion of the 12 treatment sessions).
Secondary	Disability	Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)	Follow-up at the third month after treatment completion
Secondary	Disability	Measured with Roland-Morris scale Spanish version, minimum and maximum values go from 0 (absence of disability) until 24 (maximum disability)	Follow-up at the sixth month after treatment completion
Secondary	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.	At baseline
Secondary	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.	At the first month after intervention onset (after completion of the 12 treatment sessions)
Secondary	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.	Follow-up at the third month after treatment completion
Secondary	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.	Follow-up at the sixth month after treatment completion
Secondary	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	Al baseline
Secondary	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	At the first month after intervention onset (after completion of the 12 treatment sessions)
Secondary	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	Follow-up at the third month after treatment completion
Secondary	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	Follow-up at the sixth month after treatment completion
Secondary	Catastrophism	Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.	At baseline
Secondary	Catastrophism	Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.	At the first month after intervention onset (after completion of the 12 treatment sessions)
Secondary	Catastrophism	Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.	Follow-up at the third month after treatment completion
Secondary	Catastrophism	Measured with Pain Catastrophism Scale Spanish version. The total score ranges from 0 to 52. Higher scores reflect higher levels of catastrophic thinking.	Follow-up at the sixth month after treatment completion
Secondary	Cortical excitation	Measured with Critical Flicker Fusion Threshold	At baseline
Secondary	Cortical excitation	Measured with Critical Flicker Fusion Threshold	At the first month after intervention onset (after completion of the 12 treatment sessions)
Secondary	Cortical excitation	Measured with Critical Flicker Fusion Threshold	Follow-up at the third month after treatment completion
Secondary	Cortical excitation	Measured with Critical Flicker Fusion Threshold	Follow-up at the sixth month after treatment completion
Secondary	Heart Rate Variability	Measured with Polar Heart Rate belt	At baseline
Secondary	Heart Rate Variability	Measured with Polar Heart Rate belt	At the first month after intervention onset (after completion of the 12 treatment sessions)
Secondary	Heart Rate Variability	Measured with Polar Heart Rate belt	Follow-up at the third month after treatment completion
Secondary	Heart Rate Variability	Measured with Polar Heart Rate belt	Follow-up at the sixth month after treatment completion