Cervical Syndrome Clinical Trial
Official title:
Treatment of Neck Pain With Transcranial Direct Current Stimulation: A Single Blind Randomized Controlled Trial
NCT number | NCT04729270 |
Other study ID # | tDCS |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 6, 2023 |
Est. completion date | November 20, 2023 |
Verified date | April 2024 |
Source | University of Cadiz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 30 |
Est. completion date | November 20, 2023 |
Est. primary completion date | March 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients of both sexes, - Aged between 18 and 60 years, in an - Active state of pain and diagnosed with a month of evolution. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Policlínica Santa María | Cadiz | Cádiz |
Lead Sponsor | Collaborator |
---|---|
University of Cadiz |
Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Four weeks | |
Secondary | 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. | Twelve weeks | |
Secondary | Active cervical range of motion | Measured by goniometer type crom | Baseline,four weeks and Twelve weeks. | |
Secondary | Pressure pain thresholds in cervical trigger points | Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline, | Baseline,four weeks and Twelve weeks. | |
Secondary | Neck Disability Index (NDI). | Questionnaire Neck Disability Index (NDI). | Baseline,four weeks and Twelve weeks. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03184220 -
Treatment of Cervical Syndrome With Myofascial Therapies
|
N/A | |
Completed |
NCT03322683 -
Treatment of Cervical Syndrome With Physium Therapy
|
N/A |