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
Background: Cervicogenic headaches (CGH) are common following concussion and whiplash injuries and significantly reduce patient quality of life. Conservative therapies such as ET (ET) and physiotherapy combined with injection-based therapies are cornerstones of treatment for CGH but have shown limit...
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| Language: | English |
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Elsevier
2024-12-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865424001170 |
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| author | K. Jobin C. Campbell S.M. Schabrun K.J. Schneider A. Smith C.T. Debert |
| author_facet | K. Jobin C. Campbell S.M. Schabrun K.J. Schneider A. Smith C.T. Debert |
| author_sort | K. Jobin |
| collection | DOAJ |
| description | Background: Cervicogenic headaches (CGH) are common following concussion and whiplash injuries and significantly reduce patient quality of life. Conservative therapies such as ET (ET) and physiotherapy combined with injection-based therapies are cornerstones of treatment for CGH but have shown limited efficacy. Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) has shown promise in treating other chronic pain conditions. The primary aim of this trial is to evaluate the feasibility and safety of tDCS when combined with ET for the treatment of CGH. Methods: Adults (aged 18–65), blinded to treatment arm, will be randomized into one of two groups: active tDCS followed by ET or sham tDCS followed by ET. Transcranial direct current stimulation will be applied over M1 three times per week for 6-weeks and ET will be performed daily. The primary outcomes of this trial will be the feasibility and safety of the intervention. Feasibility will be defined as greater than 30 % recruitment, 70 % protocol adherence, and 80 % retention rate. Safety will be defined as no severe adverse events. Secondary exploratory outcomes will assess improvement in pain, strength, function, and quality of life. Conclusions: This trial aims to demonstrate the safety and feasibility of tDCS in combination with ET for the treatment of CGH. Cervicogenic headaches can be difficult to treat contributing to significant impairments function and quality of life. Transcranial direct current stimulation is a potential novel treatment to improve health outcomes in these patients. Registration: ClinicalTrials.gov-NCT05582616. |
| format | Article |
| id | doaj-art-aece6bd7d172401abff0d09bf21d1b34 |
| institution | OA Journals |
| issn | 2451-8654 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-aece6bd7d172401abff0d09bf21d1b342025-08-20T02:37:03ZengElsevierContemporary Clinical Trials Communications2451-86542024-12-014210137010.1016/j.conctc.2024.101370The safety and feasibility of transcranial direct current stimulation combined with conservative treatment for patients with cervicogenic headaches: A double-blinded randomized control study protocolK. Jobin0C. Campbell1S.M. Schabrun2K.J. Schneider3A. Smith4C.T. Debert5Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Alberta, CanadaDepartment of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Alberta, CanadaDepartment of Physiotherapy, University of Western Ontario, London, Ontario, Canada; The Gray Centre for Mobility and Activity, Parkwood Institute, London, Ontario, CanadaHotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada; Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada; Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada; Sport Medicine Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, CanadaDepartment of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Alberta, CanadaDepartment of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Alberta, Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada; Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada; Corresponding author. Special Services Building, Main Floor Rm 142.1403 29th St. NW, Calgary, Alberta, T2N 2T9, Canada.Background: Cervicogenic headaches (CGH) are common following concussion and whiplash injuries and significantly reduce patient quality of life. Conservative therapies such as ET (ET) and physiotherapy combined with injection-based therapies are cornerstones of treatment for CGH but have shown limited efficacy. Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) has shown promise in treating other chronic pain conditions. The primary aim of this trial is to evaluate the feasibility and safety of tDCS when combined with ET for the treatment of CGH. Methods: Adults (aged 18–65), blinded to treatment arm, will be randomized into one of two groups: active tDCS followed by ET or sham tDCS followed by ET. Transcranial direct current stimulation will be applied over M1 three times per week for 6-weeks and ET will be performed daily. The primary outcomes of this trial will be the feasibility and safety of the intervention. Feasibility will be defined as greater than 30 % recruitment, 70 % protocol adherence, and 80 % retention rate. Safety will be defined as no severe adverse events. Secondary exploratory outcomes will assess improvement in pain, strength, function, and quality of life. Conclusions: This trial aims to demonstrate the safety and feasibility of tDCS in combination with ET for the treatment of CGH. Cervicogenic headaches can be difficult to treat contributing to significant impairments function and quality of life. Transcranial direct current stimulation is a potential novel treatment to improve health outcomes in these patients. Registration: ClinicalTrials.gov-NCT05582616.http://www.sciencedirect.com/science/article/pii/S2451865424001170Transcranial direct current stimulationCervicogenic headachePost-traumatic headachePhysiotherapyExerciseNeuromodulation |
| spellingShingle | K. Jobin C. Campbell S.M. Schabrun K.J. Schneider A. Smith C.T. Debert 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 Contemporary Clinical Trials Communications Transcranial direct current stimulation Cervicogenic headache Post-traumatic headache Physiotherapy Exercise Neuromodulation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | safety and feasibility of transcranial direct current stimulation combined with conservative treatment for patients with cervicogenic headaches a double blinded randomized control study protocol |
| topic | Transcranial direct current stimulation Cervicogenic headache Post-traumatic headache Physiotherapy Exercise Neuromodulation |
| url | http://www.sciencedirect.com/science/article/pii/S2451865424001170 |
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