- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746250
Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
February 26, 2019 updated by: Lærke Tørring Kolding, Danish Headache Center
The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent Episodic Tension Type Headache before and after treatment with amitriptyline - and to compare the results with healthy individuals.
Study Overview
Detailed Description
The muscle stiffness is measured with ultrasonic shear wave elastography in m. masseter, m. sternocleidomastoid and m. Trapezius.
The muscle soreness is measured by palpation of the muscles aided by a so called palpometer.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Glostrup, Denmark, 2600
- Danish Headache Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tension type headache
The investigator measures the muscle soreness and muscle stiffness before the patients starts their prescribed treatment with amitriptyline - and again after they have reached their optimal dosage of amitriptyline.
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The investigator recruits patients who have already discussed and agreed to the amitriptyline treatment with their physician.
The patients start the treatment after the investigator have measured them once.
Other Names:
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No Intervention: Healthy controls
The investigator measures the muscle soreness and muscle stiffness once.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Tenderness Score
Time Frame: March 2016 to march 2018. Up to 4 months.
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The soreness of the muscle is reported by the patient on a scale from 0-3 (0= no pain, 1= mild pain, 2= moderate pain and 3= severe pain) when pressure is applied at eight different locations on both sides of the face and neck (m.
masseter, m. frontalis, m. pterygoideus lateralis, m. temporalis, m. sternocleidomastoid, pros.
mastoideus, m. trapezius and the insertions of the neck muscles at the base of the scull.)
The sum of the individual scores make up the total tenderness.
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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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The stiffness is measured in terms of the speed of the shear waves (meter/second) the higher the speed the stiffer the muscle.
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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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Aided by a palpometer a pressure of 160 U is applied to four different locations (m.
masseter, m. sternocleidomastoid, the lateral part of m. trapezius and the medial part of the m.
trapezius.)
At each location the patient report the pain intensity on a scale from 0-10.
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March 2016 to march 2018. Up to 4 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Henrik W Schytz, MD, DMSc, Danish Headache Center, Department of neurology, Rigshospitalet Glostrup
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
April 13, 2016
First Submitted That Met QC Criteria
April 18, 2016
First Posted (Estimate)
April 21, 2016
Study Record Updates
Last Update Posted (Actual)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 26, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Musculoskeletal Pain
- Headache Disorders, Primary
- Headache Disorders
- Myalgia
- Headache
- Tension-Type Headache
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Amitriptyline
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
Other Study ID Numbers
- H-16000619
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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