Trigger Point Massage in Chronic Tension Headache
Efficacy of Trigger Points Massage in Severity of Chronic Tension Headache:An Unmasked, Randomized, Controlled Trial
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedFirst Submitted
Initial submission to the registry
January 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedJanuary 18, 2020
January 1, 2020
3.1 years
January 13, 2020
January 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Headache frequency change
Change in number of attacks in week 4 from the base line
Headache duration change
Change in Time duration in week 4 from the baseline
Number of analgesic change
Change in Number of analgesic drugs used in week 4 from the baseline
Study Arms (2)
Intervention
EXPERIMENTALTrigger point massage
Control
ACTIVE COMPARATORTreatment with standard drug Nortriptyline
Interventions
Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor in Neurology
Study Record Dates
First Submitted
January 13, 2020
First Posted
January 18, 2020
Study Start
February 15, 2016
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share