NCT04729270

Brief Summary

This study aim to investigate the effects of Transcranial Direct Current Stimulation for improving pressure pain thresholds (PPTs), range of motion,Neck Disability Index, the multidimensional health related quality of life (SF-12) and the multidimensional health related quality of life and pain in patients with mechanical neck pain (NP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
2 years until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

January 24, 2021

Last Update Submit

April 15, 2024

Conditions

Keywords

Neck PainPhysical Therapy ModalitiesManual TherapymassageTranscranial Direct Current StimulationTranscutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • The intensity of cervical pain

    A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.

    Baseline

Secondary Outcomes (5)

  • The intensity of cervical pain

    Four weeks

  • The intensity of cervical pain

    Twelve weeks

  • Active cervical range of motion

    Baseline,four weeks and Twelve weeks.

  • Pressure pain thresholds in cervical trigger points

    Baseline,four weeks and Twelve weeks.

  • Neck Disability Index (NDI).

    Baseline,four weeks and Twelve weeks.

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.

Procedure: Physiotherapy treatment with physium device.

CONTROL GROUP

EXPERIMENTAL

The intervention for this group consisted of 10 sessions with Transcutaneous Electrical Nerve Stimulation (TENS) for a month.

Procedure: Conventional physiotherapy treatment.

Interventions

The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.

EXPERIMENTAL GROUP

The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.

CONTROL GROUP

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of both sexes,
  • Aged between 18 and 60 years, in an
  • Active state of pain and diagnosed with a month of evolution.

You may not qualify if:

  • \- Patients who are pregnant, have pacemaker and those Surgically operated cervical spine - Patients who have been treated with Transcranial Direct Current Stimulation a month earlier.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlínica Santa María

Cadiz, Cádiz, 11007, Spain

Location

Related Publications (17)

  • Whiteford CM, Steinbeck L, Dommerholt J. On "Clinical Practice Guideline for Physical Therapy Assessment and Treatment in Patients With Nonspecific Neck Pain," Bier JD, Scholten-Peeters WGM, Staal JB, et al. Phys Ther. 2018;98:162-171. Phys Ther. 2018 Sep 1;98(9):819-820. doi: 10.1093/ptj/pzy078. No abstract available.

    PMID: 29961845BACKGROUND
  • Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.

    PMID: 25659245BACKGROUND
  • Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.

    PMID: 28807894BACKGROUND
  • Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.

    PMID: 28666405BACKGROUND
  • Cote P, Yu H, Shearer HM, Randhawa K, Wong JJ, Mior S, Ameis A, Carroll LJ, Nordin M, Varatharajan S, Sutton D, Southerst D, Jacobs C, Stupar M, Taylor-Vaisey A, Gross DP, Brison RJ, Paulden M, Ammendolia C, Cassidy JD, Loisel P, Marshall S, Bohay RN, Stapleton J, Lacerte M. Non-pharmacological management of persistent headaches associated with neck pain: A clinical practice guideline from the Ontario protocol for traffic injury management (OPTIMa) collaboration. Eur J Pain. 2019 Jul;23(6):1051-1070. doi: 10.1002/ejp.1374. Epub 2019 Feb 28.

    PMID: 30707486BACKGROUND
  • Fitzgibbon BM, Schabrun SM. Transcranial Direct Current Stimulation for Pain Disorders: Challenges and New Frontiers. Clin Pharmacol Ther. 2019 Oct;106(4):717-719. doi: 10.1002/cpt.1544. Epub 2019 Jul 15. No abstract available.

    PMID: 31309544BACKGROUND
  • Yalinay Dikmen P, Yavuz BG, Aydinlar EI. The relationships between migraine, depression, anxiety, stress, and sleep disturbances. Acta Neurol Belg. 2015 Jun;115(2):117-22. doi: 10.1007/s13760-014-0312-0. Epub 2014 Jun 3.

    PMID: 24889393BACKGROUND
  • Schwartz DP, Robbins MS. Primary headache disorders and neuro-ophthalmologic manifestations. Eye Brain. 2012 Sep 13;4:49-61. doi: 10.2147/EB.S21841. eCollection 2012.

    PMID: 28539781BACKGROUND
  • Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618.

    PMID: 22085959BACKGROUND
  • Martelletti P, Jensen RH, Antal A, Arcioni R, Brighina F, de Tommaso M, Franzini A, Fontaine D, Heiland M, Jurgens TP, Leone M, Magis D, Paemeleire K, Palmisani S, Paulus W, May A; European Headache Federation. Neuromodulation of chronic headaches: position statement from the European Headache Federation. J Headache Pain. 2013 Oct 21;14(1):86. doi: 10.1186/1129-2377-14-86.

    PMID: 24144382BACKGROUND
  • Charvet LE, Shaw MT, Bikson M, Woods AJ, Knotkova H. Supervised transcranial direct current stimulation (tDCS) at home: A guide for clinical research and practice. Brain Stimul. 2020 May-Jun;13(3):686-693. doi: 10.1016/j.brs.2020.02.011. Epub 2020 Feb 10.

    PMID: 32289698BACKGROUND
  • Caulfield KA, Badran BW, DeVries WH, Summers PM, Kofmehl E, Li X, Borckardt JJ, Bikson M, George MS. Transcranial electrical stimulation motor threshold can estimate individualized tDCS dosage from reverse-calculation electric-field modeling. Brain Stimul. 2020 Jul-Aug;13(4):961-969. doi: 10.1016/j.brs.2020.04.007. Epub 2020 Apr 21.

    PMID: 32330607BACKGROUND
  • DaSilva AF, Truong DQ, DosSantos MF, Toback RL, Datta A, Bikson M. State-of-art neuroanatomical target analysis of high-definition and conventional tDCS montages used for migraine and pain control. Front Neuroanat. 2015 Jul 15;9:89. doi: 10.3389/fnana.2015.00089. eCollection 2015.

    PMID: 26236199BACKGROUND
  • Auvichayapat P, Janyacharoen T, Rotenberg A, Tiamkao S, Krisanaprakornkit T, Sinawat S, Punjaruk W, Thinkhamrop B, Auvichayapat N. Migraine prophylaxis by anodal transcranial direct current stimulation, a randomized, placebo-controlled trial. J Med Assoc Thai. 2012 Aug;95(8):1003-12.

    PMID: 23061303BACKGROUND
  • Straudi S, Buja S, Baroni A, Pavarelli C, Pranovi G, Fregni F, Basaglia N. The effects of transcranial direct current stimulation (tDCS) combined with group exercise treatment in subjects with chronic low back pain: a pilot randomized control trial. Clin Rehabil. 2018 Oct;32(10):1348-1356. doi: 10.1177/0269215518777881. Epub 2018 May 21.

    PMID: 29783893BACKGROUND
  • Andrade SM, de Brito Aranha REL, de Oliveira EA, de Mendonca CTPL, Martins WKN, Alves NT, Fernandez-Calvo B. Transcranial direct current stimulation over the primary motor vs prefrontal cortex in refractory chronic migraine: A pilot randomized controlled trial. J Neurol Sci. 2017 Jul 15;378:225-232. doi: 10.1016/j.jns.2017.05.007. Epub 2017 May 3.

    PMID: 28566169BACKGROUND
  • Przeklasa-Muszynska A, Kocot-Kepska M, Dobrogowski J, Wiatr M, Mika J. Transcranial direct current stimulation (tDCS) and its influence on analgesics effectiveness in patients suffering from migraine headache. Pharmacol Rep. 2017 Aug;69(4):714-721. doi: 10.1016/j.pharep.2017.02.019. Epub 2017 Mar 1.

    PMID: 28551531BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • manuel Rodríguez Huguet, Physiotherapy

    University of Cádiz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Blind researcher
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

January 24, 2021

First Posted

January 28, 2021

Study Start

February 6, 2023

Primary Completion

March 15, 2023

Study Completion

November 20, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations