Back to resultsMuscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
Primary Purpose
Tension-type Headache
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Amitriptyline
Sponsored by
About this trial
This is an interventional basic science trial for Tension-type Headache
Eligibility Criteria
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
Sites / Locations
- Danish Headache center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Tension type headache
Healthy controls
Arm Description
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.
The investigator measures the muscle soreness and muscle stiffness once.
Outcomes
Primary Outcome Measures
Change in Total Tenderness Score
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.
Change in muscle stiffness
The stiffness is measured in terms of the speed of the shear waves (meter/second) the higher the speed the stiffer the muscle.
Change in Local Tenderness Score
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02746250
First Posted
April 13, 2016
Last Updated
February 26, 2019
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT02746250
Brief Title
Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
Official Title
Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-type Headache
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tension type headache
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
The investigator measures the muscle soreness and muscle stiffness once.
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Other Intervention Name(s)
Saroten, Tricyclic antidepressants
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Total Tenderness Score
Description
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.
Time Frame
March 2016 to march 2018. Up to 4 months.
Title
Change in muscle stiffness
Description
The stiffness is measured in terms of the speed of the shear waves (meter/second) the higher the speed the stiffer the muscle.
Time Frame
March 2016 to march 2018. Up to 4 months.
Title
Change in Local Tenderness Score
Description
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.
Time Frame
March 2016 to march 2018. Up to 4 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik W Schytz, MD, DMSc
Organizational Affiliation
Danish Headache Center, Department of neurology, Rigshospitalet Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
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