Tension-Type Headache Clinical Trial
Official title:
Efficacy of Trigger Points Massage in Severity of Chronic Tension Headache:An Unmasked, Randomized, Controlled Trial
NCT number | NCT04232046 |
Other study ID # | 1288 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 15, 2016 |
Est. completion date | March 15, 2019 |
Verified date | January 2020 |
Source | Mazandaran University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with IHS criteria of chronic tension headache , considering inclusion and exclusion
criteria, enrolled to this study. They will be randomized to intervention or control group by
block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or
trigger point massage.
They report severity, frequency, duration of headaches and number of analgesic drugs in diary
during week 1 and week 4. Then data based on dairy will be analysis.
Status | Completed |
Enrollment | 80 |
Est. completion date | March 15, 2019 |
Est. primary completion date | March 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Chronic tension type headache according to IHS criteria 2. Finding painful trigger point in physical examination 3. no contraindication for massage 4. no prophylactic treatment 5. written inform consent Exclusion Criteria: 1. Dementia or severe cognitive impairment 2. Under Treatment with drugs with prophylactic effect 3. History of RA or Cervicocephalic fracture or other skeletal deformity 4. Other complementary treatment |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mazandaran University of Medical Sciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Headache severity change | By Visual Analogue Scale score,from 0 that indicate no pain to 10 that indicate severe pain | Mean Visual Analogue Scale sore change in week 4 from the baseline | |
Secondary | Headache frequency change | Number of attacks in week | Change in number of attacks in week 4 from the base line | |
Secondary | Headache duration change | Time duration ( in minutes)of attacks in week | Change in Time duration in week 4 from the baseline | |
Secondary | Number of analgesic change | Number of analgesic drugs used during a week | Change in Number of analgesic drugs used in week 4 from the baseline |
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