Clinical Trials Logo

Clinical Trial Summary

Headache disorders are prevalent, disabling, under recognized, under diagnosed and under treated. Migraine has a prevalence of 10% in men and 25% in women in Canada. The treatment of migraine is based on patient education (lifestyle habit modification, trigger avoidance), and pharmacological acute treatment and prophylaxis. A multidisciplinary approach allows a repartition of tasks between different health professionals.

In a 2010 meeting, the Canadian Headache Society members supported the concept of Headache Centers, and a headache nurse was judged as an essential component of such centers.

Gaul has reviewed the structured multidisciplinary approach that could be used in a headache centre and the existing studies using such structures. Five studies did include a headache nurse. No study did observe the impact of a nurse only. Resources in medical care are limited. One study did use a program of 96 hours, which does not seem realistic on the long-term and for a large pool of patients in a public hospital. Patients are not always able to pay for paramedical help such as physiotherapy and psychotherapy. Even if they do, finding a specialized therapist for chronic headache is difficult. Defining the role of a nurse and demonstrating the impact on patient care is therefore a first step in the concept of a headache center. Possible roles of a headache nurse according to Gaul are patient education, follow-up of the treatment plan, addressing patient queries, and monitoring of patient progress. The headache nurse may also participate in research projects. In a hospital Headache Clinic, the nurse may be involved in intra-venous treatments and blood sampling for research.

In summary, evidence to demonstrate the impact of a nurse in a headache clinic is lacking. We propose to study this aspect prospectively. A study with positive findings would encourage health ministers to fund and support headache nurses for headache centers across Canada for headache management. Chronic headache and therefore chronic migraine would be a focus of such centers, since most patients seen in specialized centers are chronic.

HYPOTHESIS: The addition of a headache nurse to the headache team will help the CHUM Migraine Clinic to improve treatment outcome, and reduce the burden of headache. This multidisciplinary approach will also allow a higher efficiency of the team.


Clinical Trial Description

STUDY DESIGN:

The goal of this study is to compare two treatment approaches for migraineurs. The first approach will be based on the physician only and is limited to fixed appointments (control group). The second approach will be based on a team involving a headache nurse (active group) who will participate in patient education and follow-up. The goal is to improve patient outcome but also physician productivity.

First 100 patients (control group, phase 1): patients with episodic and chronic migraine will be screened, sign consent and be enrolled. They will be seen by the physician only, without the nurse's support. This situation will reproduce the actual conditions at the clinic. During this phase, the nurse will be involved in the follow-up of known patients (who will not be included in the protocol) and data collection. She will develop her headache management abilities and help the physicians to develop some educational tools for patients.

Following 100 patients (active group, phase 2) : patients with episodic and chronic migraine will be screened and enroled. They will be seen by the physician and nurse team, with a treatment plan tailored to specific needs including regular scheduled visits, follow-up of chronification factors and educational sessions. Phone call follow-ups will be planned. Patients will have an easier and quicker contact with the team in an emergency situation. ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01804517
Study type Observational [Patient Registry]
Source Notre-Dame Hospital, Montreal, Quebec, Canada
Contact
Status Completed
Phase N/A
Start date February 2013
Completion date November 2015

See also
  Status Clinical Trial Phase
Completed NCT05720819 - Biofeedback-VR for Treatment of Chronic Migraine N/A
Not yet recruiting NCT06428838 - Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context Phase 3
Recruiting NCT05517200 - Pilot Study for a Machine Learning Test for Migraine
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Completed NCT02514148 - Biobehavioral Physical Therapy Strategies Based on Therapeutic Exercise Applied to Chronic Migraine Patients N/A
Enrolling by invitation NCT02291380 - A Study to Evaluate Botulinum Toxin Type A for Injection(HengLi®)for Prophylactic Treatment of Chronic Migraine Phase 3
Completed NCT02122237 - Cathodal tDCS in Chronic Migraine: Neurophysiological Study and Pilot Therapeutic Trial Phase 3
Withdrawn NCT02122744 - RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine N/A
Recruiting NCT02202486 - Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI N/A
Completed NCT01709708 - Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine Phase 4
Completed NCT01741246 - Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging N/A
Completed NCT01090050 - Treximet in the Treatment of Chronic Migraine Phase 4
Recruiting NCT03507400 - Introvision for Migraine and Headaches N/A
Completed NCT04161807 - Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine N/A
Completed NCT03175263 - OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain N/A
Withdrawn NCT04353505 - Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache Phase 1
Completed NCT01667250 - Non-Invasive Neurostimulation for the Prevention of Chronic Migraine N/A
Completed NCT01700387 - A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency Phase 4
Not yet recruiting NCT01135784 - Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache Phase 2
Completed NCT01496950 - Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine Phase 1