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

NCT ID: NCT05292599

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-13
• Study Completion Date: 2023-06-20

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

Conditions

Migraine; Exercises

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Supervised

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.

Group Type: EXPERIMENTAL

Experimental

Intervention Type: OTHER

CCFE will be performed with the patient in a supine position with both knees flexed at 45°. This exercise involves a craniocervical movement. The IFE will be performed with the patient in a supine position while the IEE will be performed in a prone position. Both exercises will activate cervical muscles. RFE and RRE will be performed with the patient in a sitting or standing position at the same time he resists with his hands on his head. ME the function of these exercises is to depress and stabilize the scapula.

No supervised

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

CCFE will be performed with the patient in a supine position with both knees flexed at 45°. This exercise involves a craniocervical movement. The IFE will be performed with the patient in a supine position while the IEE will be performed in a prone position. Both exercises will activate cervical muscles. RFE and RRE will be performed with the patient in a sitting or standing position at the same time he resists with his hands on his head. ME the function of these exercises is to depress and stabilize the scapula.

Interventions

Experimental

CCFE will be performed with the patient in a supine position with both knees flexed at 45°. This exercise involves a craniocervical movement. The IFE will be performed with the patient in a supine position while the IEE will be performed in a prone position. Both exercises will activate cervical muscles. RFE and RRE will be performed with the patient in a sitting or standing position at the same time he resists with his hands on his head. ME the function of these exercises is to depress and stabilize the scapula.

Intervention Type: OTHER

Control

CCFE will be performed with the patient in a supine position with both knees flexed at 45°. This exercise involves a craniocervical movement. The IFE will be performed with the patient in a supine position while the IEE will be performed in a prone position. Both exercises will activate cervical muscles. RFE and RRE will be performed with the patient in a sitting or standing position at the same time he resists with his hands on his head. ME the function of these exercises is to depress and stabilize the scapula.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gran Rosario

OTHER

Sponsor Role: lead

Responsible Party

Fernando Imaz

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando Imaz, PT/MSc

Role: PRINCIPAL_INVESTIGATOR

University of Gran Rosario

Locations

Cuadi- Universidad Gran Rosario

Rosario, Santa Fe Province, Argentina

Countries

Argentina

Other Identifiers

HE versus SE in Migraine

Identifier Type: -

Identifier Source: org_study_id