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

NCT05328687 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-01-29

No results posted yet for this study

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

Conditions

  • Chronic Migraine

Interventions

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.

Sponsors & Collaborators

  • Danish Headache Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-09-01
Completion
2022-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05328687 on ClinicalTrials.gov