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

NCT06112587 | Unknown DMC

• 2 other identifiers: DHC F-23036562Danish Headache center
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Tension-Type Headache; Neck Pain

Keywords

migraine; tension-type headache; strength training; neck pain; exercise

Outcome Measures

Primary Outcomes (1)

• headache frequency

  number of days with headache

  two weeks prior to intervention, last two weeks of intervention

Secondary Outcomes (9)

• neck pain maximal intensity

  two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

• neck pain average intensity

  two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

• neck pain frequency

  two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

• headache duration

  two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

• medication intake

  two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention

Other Outcomes (21)

• Maximal Voluntary Contraction of the Neck extension

  Before intervention, after intervention and at 1 month follow up

• Maximal Voluntary Contraction of the Neck flexion

  Before intervention, after intervention and at 1 month follow up

• Maximal Voluntary Contraction of the Shoulder elevation

  Before intervention, after intervention and at 1 month follow up

Study Arms (1)

Migraine and tension-type headache patients

EXPERIMENTAL

Patients diagnosed by a neurologist following the 3rd edition of the International Classification of Headaches Disorders (ICHD-III)

Behavioral: strength training

Interventions

strength training BEHAVIORAL

A targeted 8-week strength-training course was offered as an intervention in combination with ergonomics and posture corrections and recommendations

Migraine and tension-type headache patients

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center Rigshospitalet - Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (27)

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MeSH Terms

Conditions

Migraine Disorders; Tension-Type Headache; Neck Pain; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Single-Arm Open-Label Trial

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 1, 2023
• Study Start: October 6, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: At the moment of publication and thereafter
• Access Criteria: After its publication, according to the journal's policy and under the consensus of all authors.

Locations

DK (1)