Examination of Muscle Stiffness, Tenderness and Pressure Pain Thresholds During a Cycle of Botulinum Toxin A Treatment in Chronic Migraine Patients

Chronic Migraine Clinical Trial

— BTACM  

Official title:

Examination of Muscle Stiffness, Tenderness and Pressure Pain Thresholds During a Cycle of Botulinum Toxin A Treatment in Chronic Migraine Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328687
• Other study ID #: DanishHC180322Botox
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2022
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Preventive treatment with botulinum toxin A injections is standard care for chronic migraine and follows the PREEMPT protocol. Patients are injected at 31 locations in the frontal, corrugator and procerus muscle, the temporalis muscle, the occipitalis muscle, the cervical paraspinal muscle group and the trapezius muscles (11). The treatment is repeated every 12 weeks, performed by specially trained medical doctors or nurses.

We will measure elastography of the trapezius muscle before and 5-6 weeks after botox injection. In addition measure with QST

Description:

Study population

The population considered for inclusion in the study is patients with CM treated with botulinum toxin A injections every third months at DHC. This is an observational study, and inclusion will not affect treatment. Patients will be included consecutively.

Inclusion criteria

Patients being treated (or are starting treatment) with botulinum toxin A injections in the clinical setting at the DHC. Treatment is based on confirmed CM-diagnosis according to the ICHD-III (4), diagnosed by headache specialists at DHC

Aged 18 - 65 years

Able to sign an informed consent

Exclusion criteria

Medication overuse headache

Known cervical disorders, e.g. cervical spine disc prolapses, whiplash or spinal stenosis

Change in other pharmacological preventive medication during the study period. Stable pharmacological preventive medication is allowed.

Treatment with botulinum toxin A injections

Preventive treatment with botulinum toxin A injections is standard care for chronic migraine and follows the PREEMPT protocol. Patients are injected at 31 locations in the frontal, corrugator and procerus muscle, the temporalis muscle, the occipitalis muscle, the cervical paraspinal muscle group and the trapezius muscles (11). The treatment is repeated every 12 weeks, performed by specially trained medical doctors or nurses.

Baseline characteristics

The following information is gathered for research purpose after the patients written consent is obtained.

Information collected from the patient's record or baseline questionnaire at inclusion time

Age, gender, years of migraine and chronic migraine, current use of pharmacological preventive treatment, co-morbidities, number of previous treatments with botulinum toxin A injections, level of physical activity, height (cm) and weight (kg). Any MRI or CT scans of head and neck to verify diagnosis

Information collected from baseline headache and neck pain calendar during 3 months run-in period

Headache days/month, migraine days/month, types of acute medication, days with use of acute medication, days with neck pain and menstrual cycle.

Ultrasound shear-wave elastography

For measuring the muscle stiffness, we use a linear 9 MHz ultrasound probe (9L) and the Logic E9 scanner, both from GE Healthcare (Chalfont St Giles, UK). All measurements are performed with the probe parallel to the muscle fibers. We will measure the stiffness of the trapezius muscle in the middle botulinum toxin A injection side (G1) according to the PREEMPT protocol. All data are saved as images by the observer and subsequently analyzed by a blinded observer.

Total Tenderness Score

Eight paired pericranial muscles and tendons are palpated in a standardized manner with a standardized pressure. small rotating movements are used while palpating. Subjects are asked to rate their tenderness on a 4-point scale (0-3). Scores from each location are added to get a total tenderness score (TTS) ranging from 0 to 48. The eight examined areas are the frontal muscle, temporal muscle, coronoid process, masseter muscle, mastoid process, sternocleidomastoid, trapezius muscle and neck muscle insertions.

Pressure Pain Threshold

Pressure pain threshold will be assessed bilaterally over the temporalis muscle (over injection side G1), the temporalis, and index finger. The pain threshold is defined as the minimal pressure where the sensation of pressure changes to pain. The electronic pressure algometer (Somedic Algometer type 2, Sollentuna, Sweden) will be used. Three PPT measurements are measured over each area with a 30-sec interval between two consecutive measurements at the same area. Pressure will be applied at a rate of 50 kPa /second with a 1 cm2 probe.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients being treated (or are starting treatment) with botulinum toxin A injections in the clinical setting at the DHC. Treatment is based on confirmed CM-diagnosis according to the ICHD-III (4), diagnosed by headache specialists at DHC

Aged 18 - 65 years

Able to sign an informed consent

Exclusion Criteria:

• Medication overuse headache

Known cervical disorders, e.g. cervical spine disc prolapses, whiplash or spinal stenosis

Change in other pharmacological preventive medication during the study period. Stable pharmacological preventive medication is allowed.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Diagnostic Test:
• Shear wave elastography
or measuring the muscle stiffness, we use a linear 9 MHz ultrasound probe (9L) and the Logic E9 scanner, both from GE Healthcare (Chalfont St Giles, UK). All measurements are performed with the probe parallel to the muscle fibers. We will measure the stiffness of the trapezius muscle in the middle botulinum toxin A injection side (G1) according to the PREEMPT protocol. All data are saved as images by the observer and subsequently analyzed by a blinded observer.

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle stiffness	For measuring the muscle stiffness, we use a linear 9 MHz ultrasound probe (9L) and the Logic E9 scanner, both from GE Healthcare (Chalfont St Giles, UK). All measurements are performed with the probe parallel to the muscle fibers. We will measure the stiffness of the trapezius muscle in the middle botulinum toxin A injection side (G1) according to the PREEMPT protocol. All data are saved as images by the observer and subsequently analyzed by a blinded observer.	6 months
Primary	Change in total tenderness score	Eight paired pericranial muscles and tendons are palpated in a standardized manner with a standardized pressure. small rotating movements are used while palpating. Subjects are asked to rate their tenderness on a 4-point scale (0-3). Scores from each location are added to get a total tenderness score (TTS) ranging from 0 to 48. The eight examined areas are the frontal muscle, temporal muscle, coronoid process, masseter muscle, mastoid process, sternocleidomastoid, trapezius muscle and neck muscle insertions.	6 months
Primary	Change in muscle pressure pain threshold	Pressure pain threshold will be assessed bilaterally over the temporalis muscle (over injection side G1), the temporalis, and index finger. The pain threshold is defined as the minimal pressure where the sensation of pressure changes to pain. The electronic pressure algometer (Somedic Algometer type 2, Sollentuna, Sweden) will be used. Three PPT measurements are measured over each area with a 30-sec interval between two consecutive measurements at the same area. Pressure will be applied at a rate of 50 kPa /second with a 1 cm2 probe.	6 months