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Effect of manual therapy associated with neck muscle exercise program and pain education in patients with migraine – a 3-Armed randomized clinical trial

Effect of manual therapy associated with neck muscle exercise program and pain education in patients with migraine – a 3-Armed randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7s22c75
Enrollment
Unknown
Registered
2020-12-07
Start date
2021-09-13
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical therapy treatment for migraine

Interventions

1. Therapeutic Education Group: There will be 25 participants in this group, which will be the active control. They will attend a single appointment of approximately 60 minutes, aimed at addressing pa
E02.190.599
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Sponsors

Faculdade de Medicina de Ribeirão Preto
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto
Collaborator

Eligibility

Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: individuals of both sexes, aged between 18 and 55 years, diagnosed with migraine according to the 3rd edition of the International Classification of Headache Disorders, with at least 3 days of migraine per month, in the last month.

Exclusion criteria

Exclusion criteria: other concomitant primary / secondary headaches, including tension-type and cervicogenic headache; history of facial or neck trauma; history of cervical disc herniation or cervical osteoarthritis; any systemic degenerative disease (for example: rheumatoid arthritis and lupus erythematosus); pregnancy; physiotherapy treatment for craniocervical dysfunction in the previous year; and / or who has started a new pharmacological treatment for the disease in the last three months prior to the screening of this study.

Design outcomes

Primary

MeasureTime frame
Decrease of at least 6 points in the headache-related impact of, measured by the Headache Impact Test - HIT-6. which will be applied at the baseline, at four, eight, and twelve weeks of the treatment, and at the follow-ups at 1-mo, 2-mo, and 4-mo.

Secondary

MeasureTime frame
Expected outcome 3: Increased pressure pain threshold, measured by a digital manual dynamometer (DDK-20 Kratos®) at the baseline and at four, eight, and twelve weeks of treatment.;Expected outcome 4: Increased cervical range of motion for flexion (>7.4°), extension (>4.9°), lateral flexion (>4.8°) and rotation (>7.9°), assessed using the Multi-Cervical Unit equipment (MCU, BTE technologies, Inc, 2006) at the baseline and at four, eight, and twelve weeks of treatment.;Expected outcome 5: Increased cervical muscle strength for flexion(>7.6), extension (>13.3) and lateral flexion (>9.8), assessed using the Multi-Cervical Unit equipment (MCU, BTE technologies, Inc, 2006) at the baseline and at four, eight, and twelve weeks of treatment.;Expected outcome 6: Upper cervical mobility 34°, measured the Flexion Rotation Test, using the Cervical Range of Motion device. This assessment will be performed at the baseline and at four, eight, and twelve weeks of treatment.;Expected outcome 7: Increased cervical muscle performance, assessed through the Craniocervical Flexion Test, using a pressure biofeedback unit (Stabilizer Chattanooga South Pacific; USA). This test will be performed at the baseline and at four, eight, and twelve weeks of treatment.;Decrease greater than 5 points of neck pain disability, assessed through the Neck Disability Index, at the baseline, at four, eight and twelve weeks of the treatment, and at the follow-ups at 1-mo, 2-mo and 4-months.;Expected outcome 9: Decreased cutaneous allodynia assessed using the 12-item Allodynia Symptom Checklist questionnaire, that will be applied at the baseline, at four, eight and twelve weeks of the treatment, and at the follow-ups at 1-mo, 2-mo and 4-months.;Expected outcome 10: Decreased kinesiophobia, assessed with the Tampa Scale for Kinesiophobia, applied at the baseline, at four, eight and twelve weeks of the treatment, and at the follow-ups at 1-mo, 2-mo and 4-months.;Expected outcome 11: Decreased pain-related catast

Countries

Brazil

Contacts

Public ContactGabriella;Débora Tolentino;Grossi

;

gabriella.tolentino@usp.br;deborabg@fmrp.usp.br+55(16)99612-3344;+55(16)3315-4413

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 15, 2026