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

NCT05830851 | Unknown

• 1 other identifier: tDCS&aeorbic excercise in LBP
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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.

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

Outcome Measures

Primary Outcomes (8)

• Pain intensity

  Measured with Visual Analogue Scale of 100 mm

  At baseline

• Pain intensity

  Measured with Visual Analogue Scale of 100 mm

  At the first month after intervention onset (after completion of the 12 treatment sessions).

• Pain intensity

  Measured with Visual Analogue Scale of 100 mm

  Follow-up at the third month after treatment completion

• Pain intensity

  Measured with Visual Analogue Scale of 100 mm

  Follow-up at the sixth month after treatment completion

• Pressure pain

  Measured with a pressure algometer

  At baseline

• Pressure pain

  Measured with a pressure algometer

  At the first month after intervention onset (after completion of the 12 treatment sessions).

• Pressure pain

  Measured with a pressure algometer

  Follow-up at the third month after treatment completion

• Pressure pain

  Measured with a pressure algometer

  Follow-up at the sixth month after treatment completion

Secondary Outcomes (24)

• Disability

  At baseline

• Disability

  At the first month after intervention onset (after completion of the 12 treatment sessions).

• Disability

  Follow-up at the third month after treatment completion

• Disability

  Follow-up at the sixth month after treatment completion

• Kinesiophobia

  At baseline

Study Arms (3)

aerobic exercise

ACTIVE COMPARATOR

Walk on a treadmill during 20-30 minutes at 60-80% of Heart Rate max

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.

Other: sham tDCS and aerobic exercise

real tDCS

EXPERIMENTAL

Application of real tDCS during 20 minutes at 2 mili Amper (mA)-intensity.

Other: real tDCS and aerobic exercise

Interventions

real tDCS and aerobic exercise OTHER

Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with therapeutic parameters

aerobic exercise; real tDCS

sham tDCS and aerobic exercise OTHER

Walking on a treadmill at 60-80% of HRmax while wearing a head tDCS device with sham tDCS

Sham tDCS; aerobic exercise

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European University of Madrid: lead

Study Sites (2)

Eurpean University of Madrid

Villaviciosa de Odón, Madrid, 28670, Spain

RECRUITING

Hospital Universitario Fundación Alcorcón

Alcorcón, Spain

RECRUITING

Related 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.

  PMID: 32647923 BACKGROUND

• 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.

  PMID: 34450274 BACKGROUND

• 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.

  PMID: 32006236 BACKGROUND

• 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.

  PMID: 32111675 BACKGROUND

• 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.

  PMID: 32526017 BACKGROUND

• 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.

  PMID: 28827229 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

• 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.

  PMID: 26903788 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

• 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.

  PMID: 32569082 BACKGROUND

• 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.

  PMID: 25529265 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marina Castel Sánchez, PhD

  European University of Madrid.Department of Physiotherapy, Chiropody and Dance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Castel- Sánchez, PhD

CONTACT

0034-679448994; marina.castel@universidadeuropea.es

Dolores Sosa- Reina, PhD

CONTACT

0034628432666; mariadolores.sosa@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Physical Therapist and associated lecturer

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 26, 2023
• Study Start: November 17, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)