The Safety and Feasibility of Transcranial Direct Current Stimulation Combined with Conservative Treatment for Cervicogenic Headaches: A double-blinded randomized control study
Bibliographic record
Abstract
Abstract Background Cervicogenic headaches (CGH) are common following concussion and whiplash injuries and significantly reduce patient quality of life. CGH is often associated with neck, jaw and/or facial pain and reduced neck mobility. Conservative therapy and 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 and headache conditions. The primary aim of this trial is to evaluate the feasibility and safety of tDCS when combined with conservative therapy for the treatment of CGH. The study will evaluate retention and dropout rates, adherence to the protocol and adverse events. Exploratory aims will investigate the association of CGH and various health outcomes, inclusive of pain intensity, headache frequency and duration, neck mobility, quality of life, pain sensitivity, and medication usage. Methods Forty adults (aged 18–65), blinded to treatment arm, will be randomized into one of two groups: active tDCS with conservative therapy or sham tDCS with conservative therapy. tDCS will be applied over M1 by a trained research assistant three times per week for 6 weeks. Conservative therapy will be provided immediately post-tDCS. The primary outcomes of this trial will be the feasibility and safety of this intervention. Feasibility will be defined as greater than 30% recruitment, greater than 70% protocol adherence, and greater than 70% retention rate. Safety will be defined as no severe adverse events and less than 30% increase in adverse effects. Secondary exploratory outcomes will be assessed using the following: numeric pain rating scale (NPRS), headache impact test-6 (HIT-6), rivermead PPCS questionnaire (RPQ), cranio-cervical flexion test (CCFT), cervical extensor endurance test (CEET), cervical flexor endurance test (CFET), dynamometry neck-strength assessment (DNSA), the European quality of life five dimension (EQ-5D), patient reported outcomes measurement information system (PROMIS) pain interference scale, pain catastrophizing scale (PCS), and section A - quantitative analgesics questionnaire (QAQ-A). Discussion This pilot study will be the first to evaluate the use of tDCS combined with conservative therapy for the treatment of cervicogenic headaches. Trial Registration: ClinicalTrials.gov - NCT05582616 (registered October 4th, 2022) https://clinicaltrials.gov/ct2/show/NCT05582616
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.009 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.005 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".