Tension-type headache Nervous System Diseases
Conditions
Interventions
Interventional multicenter study, 3 centers. The grouping of patients in accordance with the chronological order of 1:1: 1:1 proportion of random group assigned to the treatment group 1, Treatment Gr
Sponsors
Xiyuan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Frequent or chronic tension headache, in which the number of days of tension-type headaches is at least 5 per month and the severity of the headache is more than 4 out of 10 on a visual analog scale (VAS) 2. Aged 18-65 years 3. Has signed the informed consent letter
Exclusion criteria
Exclusion criteria: 1. Other subtypes of tension-type headache, migraine, cluster headache and other causes of headache 2. Headache caused by systemic diseases, such as cardiovascular disease, acute infectious diseases, blood diseases, endocrine metabolic diseases, allergies, poisoning, etc 3. Headache caused by facial problems, such as glaucoma, otitis media, sinusitis, wisdom teeth, and other diseases 4. Headache caused by intracranial organic lesions, such as intracranial infection, brain tumor, subarachnoid hemorrhage, etc 5. Blood pressure control not ideal 6. Severe anxiety or severe depression 7. Serious hypertension or serious heart, liver or kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of headaches assessed using patient-reported headache diary. The patient recorded a daily headache diary during the clinical trial, starting from recruitment date to the end of trial. The diary asks the patient to fill in information only if a headache occurs, otherwise it is left blank. The degree of severity of headache was subjectively rated by the patient using the NRS scale. The patient also recorded a qualitative description of the headache using qualifiers such as aching, throbbing, sharp, dull or pounding. Also the patient recorded how long the headache lasted and if ibuprofen was taken, including mg amount and number of tablets. 2. Degree of headache assessed using a numerical rating scale (NRS) scale at baseline (week 0 after randomization), first week of treatment (week 5 after randomization), after the end of treatment period (week 10 after randomization), first follow-up (week 16 after randomization) and second follow-up (week 24 after randomization) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Headache disability was evaluated by MIDAS questionnaire at baseline (week 0 after randomization), first week of treatment (week 5 after randomization), after the end of treatment period (week 10 after randomization), first follow-up (week 16 after randomization) and second follow-up (week 24 after randomization) 2. Depressive mood assessed using the PHQ-9 scale at baseline (week 0 after randomization), first week of treatment (week 5 after randomization), first follow-up (week 16 after randomization) and second follow-up (week 24 after randomization) 3. Anxiety assessed using GAD-7 Generalized Anxiety scale at baseline (week 0 after randomization), first week of treatment (week 5 after randomization), after the end of treatment period (week 10 after randomization), first follow-up (week 16 after randomization) and second follow-up (week 24 after randomization) 4. Quality of life assessed using the the SF-12 questionnaire at baseline (week 0 after randomization), first week of treatment (week 5 after randomization), first follow-up (week 16 after randomization) and second follow-up (week 24 after randomization) | — |
Countries
China
Contacts
Public ContactPhilip Lee
Outcome results
None listed