Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02746250|
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tension-type Headache||Drug: Amitriptyline||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
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.
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.
No Intervention: Healthy controls
The investigator measures the muscle soreness and muscle stiffness once.
- Change in Total Tenderness Score [ Time Frame: March 2016 to march 2018. Up to 4 months. ]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 [ Time Frame: March 2016 to march 2018. Up to 4 months. ]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 [ Time Frame: March 2016 to march 2018. Up to 4 months. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746250
|Danish Headache center|
|Glostrup, Denmark, 2600|
|Principal Investigator:||Henrik W Schytz, MD, DMSc||Danish Headache Center, Department of neurology, Rigshospitalet Glostrup|