Trigger Point Massage in Chronic Tension Headache
Primary Purpose
Tension-Type Headache
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Massage
Sponsored by
About this trial
This is an interventional treatment trial for Tension-Type Headache focused on measuring Massage, Trigger point
Eligibility Criteria
Inclusion Criteria:
- Chronic tension type headache according to IHS criteria
- Finding painful trigger point in physical examination
- no contraindication for massage
- no prophylactic treatment
- written inform consent
Exclusion Criteria:
- Dementia or severe cognitive impairment
- Under Treatment with drugs with prophylactic effect
- History of RA or Cervicocephalic fracture or other skeletal deformity
- Other complementary treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Trigger point massage
Treatment with standard drug Nortriptyline
Outcomes
Primary Outcome Measures
Headache severity change
By Visual Analogue Scale score,from 0 that indicate no pain to 10 that indicate severe pain
Secondary Outcome Measures
Headache frequency change
Number of attacks in week
Headache duration change
Time duration ( in minutes)of attacks in week
Number of analgesic change
Number of analgesic drugs used during a week
Full Information
NCT ID
NCT04232046
First Posted
January 13, 2020
Last Updated
January 15, 2020
Sponsor
Mazandaran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04232046
Brief Title
Trigger Point Massage in Chronic Tension Headache
Official Title
Efficacy of Trigger Points Massage in Severity of Chronic Tension Headache:An Unmasked, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mazandaran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
Keywords
Massage, Trigger point
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Trigger point massage
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment with standard drug Nortriptyline
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.
Primary Outcome Measure Information:
Title
Headache severity change
Description
By Visual Analogue Scale score,from 0 that indicate no pain to 10 that indicate severe pain
Time Frame
Mean Visual Analogue Scale sore change in week 4 from the baseline
Secondary Outcome Measure Information:
Title
Headache frequency change
Description
Number of attacks in week
Time Frame
Change in number of attacks in week 4 from the base line
Title
Headache duration change
Description
Time duration ( in minutes)of attacks in week
Time Frame
Change in Time duration in week 4 from the baseline
Title
Number of analgesic change
Description
Number of analgesic drugs used during a week
Time Frame
Change in Number of analgesic drugs used in week 4 from the baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Chronic tension type headache according to IHS criteria
Finding painful trigger point in physical examination
no contraindication for massage
no prophylactic treatment
written inform consent
Exclusion Criteria:
Dementia or severe cognitive impairment
Under Treatment with drugs with prophylactic effect
History of RA or Cervicocephalic fracture or other skeletal deformity
Other complementary treatment
12. IPD Sharing Statement
Plan to Share IPD
No
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Trigger Point Massage in Chronic Tension Headache
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