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Table 4 Study endpoints

From: The HortONS study. Treatment of chronic cluster headache with transcutaneous electrical nerve stimulation and occipital nerve stimulation: study protocol for a prospective, investigator-initiated, double-blinded, randomized, placebo-controlled trial

Primary endpoints:

1. 30% reduction in attack frequency with TENS and ONS

2. Safety in ONS and TENS treatment

Secondary endpoints

1. Participant’s assessment of treatment effect evaluated by PGIC-score

2. Treatment efficacy of burst versus tonic ONS as a preventive treatment for chronic cluster headache

3. Feasibility of TENS as a predictor for the outcome of ONS treatment

4. 30% reduction in pain intensity

5. Quality of life as evaluated with the EuroQoL-5D questionnaire

6. Reduction in background headache

7. Self-reported sleep quality

8. Symptoms of anxiety and depression as evaluated by HADS

  1. TENS Transcutaneous electrical nerve stimulation, ONS Occipital nerve stimulation, PGIC Patient's global impression of change, HADS Hospital anxiety, and depression scale, EuroQoL-5D European Quality of Life – 5 Dimensions
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BMC Neurology

ISSN: 1471-2377

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