Tension-type HeadacheNCT02746250
Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
A study testing Amitriptyline in people with Tension-type Headache, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tension-type Headache
- What is being tested?
- Amitriptyline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Tension-type Headache
- Being tested
- Amitriptyline
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
Also called Saroten, Tricyclic antidepressants
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.
| Study group | Role | What they receive |
|---|---|---|
| Tension type headache | Active comparator | 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. Receives: Drug: Amitriptyline |
| Healthy controls | No intervention | The investigator measures the muscle soreness and muscle stiffness once. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: March 2016 to march 2018. Up to 4 months.
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.
Measured: March 2016 to march 2018. Up to 4 months.
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.
Measured: March 2016 to march 2018. Up to 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lærke Tørring Kolding, Danish Headache Center
- Investigators
- Henrik W Schytz, MD, DMSc, Principal investigator, Danish Headache Center, Department of neurology, Rigshospitalet Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746250
- Sponsor's protocol ID
- H-16000619
- Status last verified
- Feb 2019
- First submitted
- 13 Apr 2016
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
- ClinicalTrials.gov ID
- NCT02746250
- Acronym / sponsor ID
- H-16000619
- Conditions
- Tension-type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tension type headache | Active comparator | Drug: AmitriptylineThe 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. |
| Healthy controls | No intervention | –The investigator measures the muscle soreness and muscle stiffness once. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmitriptylineAlso: Saroten, Tricyclic antidepressantsThe 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. | Drug | Tension type headache |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik W Schytz, MD, DMSc principal investigator
Danish Headache Center, Department of neurology, Rigshospitalet Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amitriptyline in people with Tension-type Headache, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Tenderness Score (time frame: March 2016 to march 2018. Up to 4 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.