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

NCT05328687 | Completed

• 1 other identifier: DanishHC180322Botox
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

Shear wave elastography DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic migraine referred to the Danish Headache center

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Neurology

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 14, 2022
• Study Start: May 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

DK (1)