Effect of a Home-based Versus Supervised Exercise Program in Patients With Migraine

University of Gran Rosario

Status: Completed

Conditions: Migraine; Exercises

Treatments: Other: Control; Other: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT05292599

HE versus SE in Migraine

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Supervised

Experimental group

Description:

All participants in this arm will receive physiotherapy treatment that includes craniocervical flexion exercise (CCFE), isometric flexion exercises (IFE), isometric extension exercises (IEE), self-resistance exercise for neck flexion and extension (RFE), self-resistance exercise for neck rotation (RRE), midscapular exercise (ME) in 2 sessions for week, 60 minutes each, for 8 weeks. CCFE will focus on the recruitment of the deep cervical flexor muscles and will be performed from lower to higher complexity. Each of the exercises will be for 3 sets of 10 repetitions with 10 seconds of isometric contraction during the 8 weeks. IFE and IEE consist of 3 sets of 8 repetitions with 6 seconds of isometric contraction, for 6 weeks. For self-resistance exercises, the patient performs RFE and RRE. These exercises will be performed with 3 sets of 8 repetitions with 6 seconds of isometric contraction during the 8 weeks. The ME will be performed in 3 sets of 8 repetitions during the 5 weeks.

Treatment:

Other: Experimental

No supervised

Active Comparator group

Description:

The participants will perform the same exercises as the supervised group. However, in this arm will be instructed to perform the same exercises as the experimental group at home, without any supervision. These instructions will be given by the physiotherapist through videos and/or photos.

Treatment:

Other: Control