Treatment of Neck Pain With Transcranial Direct Current Stimulation
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
January 28, 2021
CompletedStudy Start
First participant enrolled
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2023
CompletedApril 17, 2024
April 1, 2024
1 month
January 24, 2021
April 15, 2024
Conditions
Keywords
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
EXPERIMENTALThe intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
CONTROL GROUP
EXPERIMENTALThe intervention for this group consisted of 10 sessions with Transcutaneous Electrical Nerve Stimulation (TENS) for a month.
Interventions
The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.
Eligibility Criteria
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
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: 29961845BACKGROUNDCohen 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: 25659245BACKGROUNDCohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
PMID: 28807894BACKGROUNDBlanpied 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: 28666405BACKGROUNDCote 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: 30707486BACKGROUNDFitzgibbon 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: 31309544BACKGROUNDYalinay 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: 24889393BACKGROUNDSchwartz 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: 28539781BACKGROUNDNitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618.
PMID: 22085959BACKGROUNDMartelletti 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: 24144382BACKGROUNDCharvet 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: 32289698BACKGROUNDCaulfield 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: 32330607BACKGROUNDDaSilva 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: 26236199BACKGROUNDAuvichayapat 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: 23061303BACKGROUNDStraudi 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: 29783893BACKGROUNDAndrade 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: 28566169BACKGROUNDPrzeklasa-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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
manuel Rodríguez Huguet, Physiotherapy
University of Cádiz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Blind researcher
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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