Clinical trial NCT05292599: Effect of a Home-based Versus Supervised Exercise Program in Patients With Migraine
Official title: Effect of a Home-based Versus Supervised Exercise Program in Patients With Migraine: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Exercises
Keywords: Craniocervical flexion exercises
Neck exercises
Axioscapular exercises
Lead sponsor: University of Gran Rosario
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Migraine is a common primary headache with documented impacts on the patient, the economy, and society. A growing number of studies have reported that people with migraines are more likely to experience neck pain and neck dysfunction. The coexistence of migraine and neck pain is also associated with a higher frequency of migraine attacks, greater susceptibility to certification. It has been reported that they present decreased cervical mobility, as well as decreased strength, resistance, and coordination of the cervical musculature of the skull. The objective of this study is to evaluate the possible clinical effects in migraineurs of supervised craniocervical and axioscapular exercises versus home-based exercises.

Detailed description: This study will aim to verify the effect of home versus supervised exercise programs in migraine patients. The primary outcomes will be changes in the Visual Analog Scale (VAS) (0-10) and Migraine Disability Assessment Scores (MIDAS). Secondary outcomes will be changes in cervical range of motion; change in muscle endurance test; neck disability index (NDI), Headache Impact Test (HIT-6) score, Patient Health Questionnaire (PHQ-9) scores, Generalized Anxiety Disorder (GAD-7) scores.

Volunteers for the study will be included if they are between 18 and 55 years old, are of either sex, have been diagnosed with migraine according to the third edition of the International Classification of Headache, and have exhibited at least 3 days with migraine attacks in the previous month, then will be randomly assigned into two groups. A single therapist will administer the interventions twice a week for 8 weeks. The experimental group (supervised) will carry out a supervised exercises program twice a week in comparison with the control group (no supervised) and will carry out a home-based exercise program twice a week. These volunteers will be recruited at the University of Gran Rosario, (Rosario, Argentina). Primary and secondary outcomes will be measured at both groups' baseline and the end of the treatment. All the evaluations will be performed by a blinded physiotherapist

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of migraine according to the beta version of the third edition of the International Classification of Headache Disorders (ICHD), with or without pharmacological treatment.
* Age ranging between 18 to 55 years, both genders

Exclusion Criteria:

* Patients with neurological disorders (neuropathic pain or neurodegenerative disease),
* Whiplash associated disorders,
* Specific neck pain (radicular pain),
* Recent dental or physical therapy.
* If patients are taking medication to relieve pain during the study, they will be encouraged to report it.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS)
timeFrame: At baseline and eighth weeks
measure: Change in MIDAS Scale (Migraine Disability Assessment Scale)
timeFrame: At baseline and eighth weeks
Secondary outcomes:
measure: The Cervical Disability Index (IDC)
timeFrame: At baseline and eighth weeks
measure: The Headache Impact Test-6 (HIT-6)
timeFrame: At baseline and eighth weeks
measure: Neck muscle strength
timeFrame: At baseline and eighth weeks
measure: Cervical flexion rotation test (FRT)
timeFrame: At baseline and eighth weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: At baseline and eighth weeks
measure: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: At baseline and eighth weeks
measure: Numeric Pain Rating Scale
timeFrame: At baseline and eighth weeks
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Cuadi- Universidad Gran Rosario
state: Santa Fe
Study officials:
affiliation: University of Gran Rosario
name: Fernando Imaz, PT/MSc
role: PRINCIPAL_INVESTIGATOR
References: