Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients. A Singel Arm Open Label Trial

Not Applicable

Active, not recruiting

• Conditions: Tension-Type Headache; Migraine; Neck Pain
• Interventions: Behavioral: strength training

• Registration Number: NCT06112587
• Lead Sponsor: Danish Headache Center

Brief Summary

A Single-Arm Open-Label Trial was performed at the Danish Headache Center (DHC), Department of Neurology, Rigshospitalet - Glostrup as part of the clinic.

Purpose:

To examine the effects of supervised group strength training and posture correction on headache frequency and muscle function around the neck and shoulders in patients with migraine and tension-type headaches.

Hypothesis:

Strength training of the neck and shoulders results in improved muscle function, which leads to a reduction in headache.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10-06
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Migraine patients with stable CGRP or botox.
• Tension type headache with no more than 5 migraine days/month.
• At least four days/months of headache at the moment of recruitment.

Exclusion Criteria

• Pregnancy
• Post-traumatic headache, or headache that is likely to be associated with trauma.
• Significant psychiatric comorbidities, such as severe depression
• Medication Overuse Headaches.
• Severe arthrosis in the neck, shoulder, or disc herniation in the neck.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Migraine and tension-type headache patients	strength training	Patients diagnosed by a neurologist following the 3rd edition of the International Classification of Headaches Disorders (ICHD-III)

Primary Outcome Measures

Name	Time	Method
headache frequency	two weeks prior to intervention, last two weeks of intervention	number of days with headache

Secondary Outcome Measures

Name	Time	Method
medication intake	two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention	number of days with medication for pain taked
neck pain frequency	two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention	number of days with neck pain
Functional level	Before intervention, after intervention and at 1 month follow up	Self-reported limitated activities due to headache in a 0-10 scale thourgh the Patient-Specific Functional Scale
Headache average Intensity	two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention	average headache intensity percieved by patient in a 0-10 NRPS
neck pain maximal intensity	two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention	maximal neck pain intensity percieved by patient in a 0-10 NRPS
neck pain average intensity	two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention	average neck pain intensity percieved by patient in a 0-10 NRPS
headache frequency	weeks 4 and 5 after intervention	number of days with headache
Headache maximal Intensity	two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention	maximal headache intensity percieved by patient in a 0-10 NRPS
headache duration	two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention	hours with headache

Trial Locations

Locations (1)

Danish Headache Center Rigshospitalet - Glostrup; 🇩🇰 Glostrup, Denmark