- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04729699
Changes and Associations Between Cervical Range of Motion, Pain, TMJ Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
Changes and Associations Between Cervical Range of Motion, Pain, Temporomandibular Joint Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Migraine is one of the most common type of headaches in the world causing the greatest disability in individuals under 50 years of age. Many different health organizations (American Headache Society etc.) recommend regular physical activity and exercise for the treatment and prevention of migraine. However, the relationship between aerobic exercise and migraine is still not completely clear. Unfortunately, a research database to validate the benefits of exercise for people with migraine is still being developed.
The aim of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular movements and quality of life in individuals with migraine.
The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-SR(M)-266).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Kaunas, Litauen
- Lithuanian University of Health Sciences, Department of Rehabilitation
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Individuals diagnosed with migraine 2 or more years ago
- Headache, occurring at least 6 times a year
- Individuals from 18 years of age
- Voluntary patient consent to participate in the study
Exclusion Criteria:
- Neurological or psychiatric disorder
- Visiting an orthodontist, taking muscle relaxants
- Head or neck injury, cervical spine hernia, facial or temporomandibular injury
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervention group
Intervention group (n=10) received 12 physiotherapy sessions and exercises for TMJ 30-45 minutes 2 days per week.
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Aerobic exercise
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Aktiv komparator: Control group
Control group (n=9) was introduced with physiotherapy program in order to perform it independently at home.
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Aerobic exercise
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Goniometry for cervical range of motion
Tidsramme: Baseline to 6 weeks
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Cervical flexion (45⁰), extension (35⁰) and lateral flexion (45⁰) were measured with mechanical goniometer.
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Baseline to 6 weeks
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Algometry for pressure pain thresholds (PPT)
Tidsramme: Baseline to 6 weeks
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PPT were measured in temporalis, upper trapezius and masticatory muscles with digital algometer in kg/cm²
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Baseline to 6 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Anthropometry for TMJ
Tidsramme: Baseline and after 6 weeks
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TMJ range of motion was measured with a centimeter before and after physiotherapy
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Baseline and after 6 weeks
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Functional health and well-being - SF-36v2®
Tidsramme: Baseline and after 6 weeks
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Quality of life was assessed with the SF-36 questionnaire.
Measure is divided into 8 subscales: Physical Functioning, Activity Limitation due to Physical Ailments, General Health, Vitality, Social Functioning, Activity Limitation due to Emotional Problems, General Mental Health and Health Transition.
Answers were scored (total score 100) and a higher total score meant a better quality of life.
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Baseline and after 6 weeks
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 001 (NavyGHB)
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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