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Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.

Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02746250
Enrollment
46
Registered
2016-04-21
Start date
2016-03-31
Completion date
2017-01-31
Last updated
2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension-type Headache

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.

Interventions

DRUGAmitriptyline

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.

Sponsors

Danish Headache Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Total Tenderness ScoreMarch 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 stiffnessMarch 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 ScoreMarch 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026