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

NCT05292599 | Completed

• 1 other identifier: HE versus SE in Migraine
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Exercises

Keywords

Craniocervical flexion exercises; Neck exercises; Axioscapular exercises

Outcome Measures

Primary Outcomes (2)

• Change in Visual Analog Scale (VAS)

  VAS is a straight horizontal line of fixed length, usually 100mm. It is a tool to assess the intensity of pain. Patients should mark their pain assessment on a scale indicated by a straight line from 0 (no pain) to 100 (pain of greatest intensity). The values will be recorded in millimeters, taken with a ruler hidden from the patient.

  At baseline and eighth weeks

• Change in MIDAS Scale (Migraine Disability Assessment Scale)

  The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over 3 months. Is the most widely used instrument to assess the degree of disability of patients. The disability that causes the headache is measured based on 5 questions that cover both the workplace and the domestic and family partner. Your score is obtained from the sum of the days lost by headache recorded in each of these activities, which translates into an explicit measure of time lost due to illness. This scale has shown that it is highly reliable, reproducible (regardless of the population groups evaluated), disease-specific and easy to rate, in addition to showing good internal consistency, high reliability and validity.

  At baseline and eighth weeks

Secondary Outcomes (7)

• The Cervical Disability Index (IDC)

  At baseline and eighth weeks

• The Headache Impact Test-6 (HIT-6)

  At baseline and eighth weeks

• Neck muscle strength

  At baseline and eighth weeks

• Cervical flexion rotation test (FRT)

  At baseline and eighth weeks

• Patient Health Questionnaire (PHQ-9)

  At baseline and eighth weeks

Study Arms (2)

Supervised

EXPERIMENTAL

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.

Other: Experimental

No supervised

ACTIVE COMPARATOR

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.

Other: Control

Interventions

Experimental 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.

Supervised

Control 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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Gran Rosario: lead

Study Sites (1)

Cuadi- Universidad Gran Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

MeSH Terms

Conditions

Migraine Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Fernando Imaz, PT/MSc

  University of Gran Rosario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: June 13, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)