Exercise alone versus combined with transcranial or trans-spinal direct current stimulation for cervicogenic headache: a randomized controlled trial protocol
DOI:
https://doi.org/10.17267/2965-3738bis.2025.e6402Keywords:
Transcranial Direct Current Stimulation, Trans-Spinal Direct Current Stimulation, Physiotherapy Modalities, Cervicogenic HeadacheAbstract
BACKGROUND: Cervicogenic headaches (CGHs) are secondary headaches that result from dysfunction of the cervical spine and are frequently linked to musculoskeletal disorders. While traditional physiotherapy provides symptomatic alleviation, neuromodulation treatments such as Transcranial electrical stimulation (tDCS) and Spinal direct current stimulation (tsDCS) have demonstrated promising results in improving treatment outcomes and altering pain perception. To manage CGH, this study compares the efficacy of tDCS, tsDCS, and supervised exercise therapy. METHODS: International Headache Society’s classification (ICHD-3) will be used to diagnose cervicogenic headache (CGH) in participants. Transcranial direct current stimulation (tDCS) along with exercise, transcutaneous spinal direct current stimulation (tsDCS) along with exercise, and exercise alone will be the three intervention groups to which ninety-nine patients will be randomly assigned. Treatment will be given for 5 consecutive days, and the exercise program will be supervised by a physiotherapist. Outcome measures will be the Headache Disability Index (HDI), Numeric Pain Rating Scale (NPRS), Cervical range of motion (CROM), pressure pain threshold (PPT) and the Headache Impact Test-6 (HIT-6). All the recordings will be done at baseline, after the five-day intervention period, and at a two-week follow-up. One-way ANOVA and repeated measures ANOVA will be used for statistical analysis to compare differences between groups and within-group changes over time. Calculations will be made for each outcome measure to get the 95% CI. DISCUSSION: With their potential to address processes of central sensitization and pain system malfunction at both the cortical and spinal levels, tDCS and tsDCS are stimulation techniques that show promise for neuromodulatory effects on the brain and spinal cord. They may also help treat cervicogenic headaches. TRIAL REGISTRATION: The registration process for the study with Clinical Trials Registry of India has been initiated (Ref. Number- REF/2023/08/071305) and has received ethical clearance from the Institutional Review Board (SBSU/PhD/2021/PT-IRB/201). PROTOCOL VERSION: Version 1.0; Dated: 21 July 2025
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References
1. Bogduk N. Cervicogenic headache: Anatomic basis and pathophysiologic mechanisms. Curr Pain Headache Rep. 2001;5(4):382-6. https://doi.org/10.1007/s11916-001-0029-7
2. Knackstedt H, Bansevicius D, Aaseth K, Grande RB, Lundqvist C, Russell MB. Cervicogenic headache in the general population: the Akershus study of chronic headache. Cephalalgia. 2010;30(12):1468-76. https://doi.org/10.1177/0333102410368442
3. Hazewinkel MHJ, Bink T, Hundepool CA, Duraku LS, Zuidam JM. Nonsurgical treatment of neuralgia and cervicogenic headache: A systematic review and meta-analysis. Plast Reconstr Surg Glob Open. 2022;10(7):e4412. https://doi.org/10.1097/gox.0000000000004412
4. Bocci T, Vannini B, Torzini A, Mazzatenta A, Vergari M, Cogiamanian F, et al. Cathodal transcutaneous spinal direct current stimulation (tsDCS) improves motor unit recruitment in healthy subjects. Neurosci Lett. 2014;578:75-9 https://doi.org/10.1016/j.neulet.2014.06.037
5. Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, et al. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017;128(1):56-92. https://doi.org/10.1016/j.clinph.2016.10.087
6. Hervik JA, Vika KS, Stub T. Transcranial direct current stimulation for chronic headaches: A randomized controlled trial. Front Pain Res. 2024;5:1353987. https://doi.org/10.3389/fpain.2024.1353987
7. Lamy J-C, Ho C, Badel A, Arrigo RT, Boakye M. Modulation of soleus H reflex by spinal DC stimulation in humans. J Neurophysiol. 2012;108(3):906-914. https://doi.org/10.1152/jn.10898.2011
8. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200-7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583
9. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211. https://doi.org/10.1177/0333102417738202
10. Jobin K, Smith A, Campbell C, Schabrun SM, Galarneau JM, Schneider KJ, et al. The safety and feasibility of transcranial direct current stimulation and exercise therapy for the treatment of cervicogenic headaches: A randomized pilot trial. Headache. 2025;65(5):845-62. https://doi.org/10.1111/head.14887
11. Herwig U, Satrapi P, Schönfeldt-Lecuona C. Using the international 10-20 EEG system for positioning of transcranial magnetic stimulation. Brain Topogr. 2003;16(2):95-99. https://doi.org/10.1023/b:brat.0000006333.93597.9d
12. Rich TL, Gillick BT. Electrode placement in transcranial direct current stimulation: How reliable is the determination of C3/C4? Brain Sci. 2019;9(3):69. https://doi.org/10.3390/brainsci9030069
13. Jabbari S, Salahzadeh Z, Sarbakhsh P, Rezaei M, Farhoudi M, Ghodrati M. Validity and reliability of Persian version of Henry Ford Hospital Headache Disability Inventory Questionnaire. Arch Iran Med. 2021;24(10):752-8. Cited: PMID: 34816697
14. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149-58. https://doi.org/10.1016/s0304-3959(01)00349-9
15. Houts CR, McGinley JS, Wirth RJ, Cady R, Lipton RB. Reliability and validity of the 6-item Headache Impact Test in chronic migraine from the PROMISE-2 study. Qual Life Res. 2021;30(3):931-43. https://doi.org/10.1007/s11136-020-02668-2
16. Haywood KL, Mars TS, Potter R, Patel S, Matharu M, Underwood M. Assessing the impact of headaches and the outcomes of treatment: A systematic review of patient-reported outcome measures (PROMs). Cephalalgia. 2018;38(7):1374-86. https://doi.org/10.1177/0333102417731348
17. Quek J, Brauer SG, Treleaven J, Pua YH, Mentiplay B, Clark RA. Validity and intra-rate reliability of an Android phone application to measure cervical range-of-motion. J Neuroeng Rehabil. 2014;11:65. https://doi.org/10.1186/1743-0003-11-65
18. Jobin K, Smith A, Campbell C, Schabrun S, Galarneau JM, Schneider KJ, et al. The treatment of cervicogenic headache with transcranial direct current stimulation and exercise therapy: A randomized control trial evaluating functional outcomes. Neurorehabilitation. 2025;56(4):511-24. https://doi.org/10.1177/10538135251325384
19. Jobin K, Campbell C, Schabrun SM, Schneider KJ, Smith A, Debert CT. The safety and feasibility of transcranial direct current stimulation combined with conservative treatment for patients with cervicogenic headaches: A double-blinded randomized control study protocol. Contemp Clin Trials Commun. 2024;42:101370. https://doi.org/10.1016/j.conctc.2024.101370
20. Cardenas-Rojas A, Pacheco-Barrios K, Giannoni-Luza S, Rivera-Torrejon O, Fregni F. Noninvasive brain stimulation combined with exercise in chronic pain: A systematic review and meta-analysis. Expert Rev Neurother. 2020;20(4):401-12. https://doi.org/10.1080/14737175.2020.1738927
21. Alhassani G, Treleaven J, Schabrun SSM. Combined transcranial and trans-spinal direct current stimulation in chronic headache: A feasibility and safety trial for a novel intervention. Hong Kong Physiother J. 2017;37:1-9. https://doi.org/10.1016/j.hkpj.2016.11.001
22. Dasilva AF, Mendonca ME, Zaghi S, Lopes M, Dossantos MF, Spierings EL, et al. tDCS-induced analgesia and electrical fields in pain-related neural networks in chronic migraine. Headache. 2012;52(8):1283-95. https://doi.org/10.1111/j.1526-4610.2012.02141.x
23. O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018;4(4):CD008208. https://doi.org/10.1002/14651858.cd008208.pub5
24. Haghdoost F, Salam A, Seyed-Kolbadi FZ, Padala D, Delcourt C, Rodgers A. Transcranial Direct Current Stimulation in Episodic Migraine: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Med Sci (Basel). 2025;13(3):84. https://doi.org/10.3390/medsci13030084
25. Cai G, Xia Z, Charvet L, Xiao F, Datta A, Androulakis XM. A systematic review and meta-analysis on the efficacy of repeated transcranial direct current stimulation for migraine. J Pain Res. 2021;14:1171-83. https://doi.org/10.2147/jpr.s295704
26. Moisset X, Pereira B, Andrade DC, Fontaine D, Lantéri-Minet M, Mawet J. Neuromodulation techniques for acute and preventive migraine treatment: a systematic review and meta-analysis of randomized controlled trials. J Headache Pain. 2020;21(1):142. https://doi.org/10.1186/s10194-020-01204-4
27. Cogiamanian F, Vergari M, Schiaffi E, Marceglia S, Ardolino G, Barbieri S, et al. Transcutaneous spinal cord direct current stimulation inhibits the lower limb nociceptive flexion reflex in human beings. Pain. 2011;152(2):370-5. https://doi.org/10.1016/j.pain.2010.10.041
28. Wu YL, Luo Y, Yang JM, Wu YQ, Zhu Q, Li Y, et al. Effects of transcranial direct current stimulation on pain and physical function in patients with knee osteoarthritis: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2024;25(1):703. https://doi.org/10.1186/s12891-024-07805-3
29. Horvath JC, Forte JD, Carter O. Quantitative Review Finds No Evidence of Cognitive Effects in Healthy Populations From Single-session Transcranial Direct Current Stimulation (tDCS). Brain Stimul. 2015;8(3):535-50. https://doi.org/10.1016/j.brs.2015.01.400
30. Antal A, Chaieb L, Moliadze V, Monte-Silva K, Poreisz C, Thirugnanasambandam N, et al. Brain-derived neurotrophic factor (BDNF) gene polymorphisms shape cortical plasticity in humans. Brain Stimul. 2010;3(4):230-7. https://doi.org/10.1016/j.brs.2009.12.003
31. Woolf CJ. Central sensitization: Implications for the diagnosis and treatment of pain. Pain. 2011;152(3 Suppl):S2-S15. https://doi.org/10.1016/j.pain.2010.09.030
32. Bocci T, Marceglia S, Vergari M, Cognetto V, Cogiamanian F, Sartucci F, et al. Transcutaneous spinal direct current stimulation modulates human corticospinal system excitability. J Neurophysiol. 2015;114(1):440-6. https://doi.org/10.1152/jn.00490.2014
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Copyright (c) 2025 Meghna Wadhwa, Arunmozhi Ranganathan
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This work is licensed under a Creative Commons Attribution 4.0 International License.
