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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02746250 |
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Date of registration:
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13/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
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Scientific title:
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Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache. |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02746250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Henrik W Schytz, MD, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Danish Headache Center, Department of neurology, Rigshospitalet Glostrup |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic Tension type headache or frequent episodic tension type headache with at least
ten episodes or more per month throughout three months or more.
- Pericranial muscle tenderness
Exclusion Criteria:
- Other primary headache disorder (with the exception of episodic migraine.)
- Pregnancy or ongoing breastfeeding
- Heart disease that contradicts treatment with amitriptyline
- Drug or substance abuse
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tension-type Headache
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Intervention(s)
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Drug: Amitriptyline
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Primary Outcome(s)
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Change in Total Tenderness Score
[Time Frame: March 2016 to march 2018. Up to 4 months.]
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Change in Local Tenderness Score
[Time Frame: March 2016 to march 2018. Up to 4 months.]
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Change in muscle stiffness
[Time Frame: March 2016 to march 2018. Up to 4 months.]
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Secondary ID(s)
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H-16000619
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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