Non-migraine headache (cluster and tension) Nervous System Diseases
Conditions
Interventions
Randomization and blinding:
Randomization for participant allocation to two groups was provided. The groups were: Experimental (ENS) and Control A (CS) receiving sham intervention. Randomization was p
Sponsors
Rezzimax Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18–50 years of age 2. Diagnosis of persistent headache criteria for at least three times/week for three months to a maximum of 5 years prior to the study (the history of chronic headache is defined as ±15 days/month for >3 months) 3. Medication, including non-steroidal anti-inflammatories, acetaminophen, ibuprofen or aspirin excluded the participant from the experimental group 4. Participants suffer from either tension-type headache (presented as dull with constant pain on both sides of the head). 5. Additional symptoms include sensitivity to light and sound, pressure-like sensation behind the eyes, and soreness in the face, head, neck, and shoulders, with episodes lasting for more than 30 minutes or cluster headaches (cluster headaches are defined as severe and recurrent headaches, including other symptoms such as wet eyes, swollen eyelids, a clogged or runny nose, sensitivity to light and sound, restlessness or agitation, along with scorching or piercing pain behind or around one eye) 8. Headaches range anywhere from 15 minutes to 3 hours and occur unexpectedly and without notice. The attacks need to happen regularly, usually a few hours after the commencement of sleep.
Exclusion criteria
Exclusion criteria: 1. Transcranial Magnetic Stimulation therapy (TMS) 2. Contraindications (e.g., pacemaker, metallic implant) 3. Migraine (International Classification of Headache Disorders-3 [ICHD-3]) 4. Other medical conditions (such as a history of seizures in the past or present, structural brain disease or disorders, psychotic disorders (e.g., schizophrenia, bipolar disorder), liver or kidney disease, cancer, uncontrolled hypertension, diabetes, or pregnancy) 5. History of any neurological disease or disorder 6. History of allergies, sinusitis, psychiatric disorder including PTSD, anxiety, depression, or fever 7. More than four cups of coffee per day, any form of medication, withdrawal from cigarettes, smoking, drugs or menstrual headache 8. Use of recreational drugs 9. Use of chronically employed drugs (e.g. non-steroidal anti-inflammatory drugs) 10. Headaches other than cluster or tension-type headaches including migraine (defined clinically as individuals who at the outset of a headache manifested symptoms that included partial loss of vision, numbness, tingling, and muscle weakness; sensitivity to light, sound and smell; nausea and/or vomiting; auras present before the headache appears, with or without the presence of zigzag lines, flashing lights or spots; or trouble speaking or finding words (dysnomia) 11. Hypnic headaches 12. Waking in the night from a headache 13. Medication-overuse headache 14. Sinus headache (occurring with sinusitis) accompanied by a throbbing, dull pain radiating over the forehead, cheeks and eyes; face pain or pressure; nasal discharge and plugged nose 15. Caffeine-related headaches with a high caffeine intake of greater than 400 mg, or around 4 cups of coffee per day 16. Head Injury or post-Head Injury headaches, menstrual headache and hangover headache
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain is measured using: 1.1. The Headache Impact Test-6 (HIT-6) 1.2. Rivermead PPCS Questionnaire (RPSQ) 1.3. Montreal Cognitive Assessment (MoCA) 1.4. Participant Health Questionnaire-9 (PHQ-9) 2. Anxiety is measured using: 2.1. Generalised Anxiety Disorder Scale-7 (GAD-7) and/or 2.2. Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Measured at baseline and after 60 and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Cuba
Contacts
Public ContactGerry Leisman
Outcome results
None listed