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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2020
Source Mazandaran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Massage
Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mazandaran University of Medical Sciences

Outcome

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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