- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02446275
Efficacy of Manual Therapy in Migraine (MTHDIQMi)
DO SOFT TISSUE TECHNIQUES HAVE A POSITIVE EFFECT ON DISABILITY AND QUALITY OF LIFE IN MIGRAINE SUFFERERS?: A Randomized Controlled Trial
Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points (MTrPs) and their stretching, often being hypersensitive in patients with migraine.
Material and methods: 27 patients in two groups participated in the study: a) the control group received combined techniques based on MTrPs and bilateral stretching in the trapezius and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same techniques as those applied in the control group plus suboccipital inhibition. The treatment lasted for 8 weeks and the impact, disability and quality of life were assessed in both groups.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Introduction Migraine is a highly prevalent disorder entailing substantial costs. Manual therapy offers an attractive option as an alternative to medical treatment or used in combination therewith. Treatment focused on the soft tissues of the suboccitpital region has been studied in other types of headaches but not in migraine.
Objective: The aim of this study was to determine the efficacy of suboccipital inhibitory manual therapy treatment in migraine compared to treatment based on Myofascial Trigger Points (MTrPs) and their stretching, often being hypersensitive in patients with migraine.
Material and methods: 27 patients in two groups participated in the study: a) the control group received combined techniques based on MTrPs and bilateral stretching in the trapezius and sternocleidomastoid muscle (SCM); b) the experimental group was applied the same techniques as those applied in the control group plus suboccipital inhibition. The treatment lasted for 8 weeks and the impact, disability and quality of life were assessed in both groups.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Valencia, Spania, 46010
- Gemma v. Espí López
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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:
- Patients were diagnosed according to the criteria established by the IHS
Exclusion Criteria:
- Patients were excluded if they presented with other headache types, if their headache was triggered by neck movement, or if they presented with dizziness, hypertension, emotional stress, psychological disorders, cardiovascular disease or pregnancy.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Sternocleidomastoid MTRP and stretching
The sternocleidomastoid was treated with ischemic compression.
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The central MTRP of the trapezius was treated as described above for the sternocleidomastoid.
Subsequently stretching was performed, whereby the therapist supported the patient's head and performed passive contralateral inclination and ipsilateral rotation of the head.
The therapist placed one hand over the patients shoulder while the other hand performed the stretching and simultaneously controlled the position of the head to achieve suitable stretching
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Eksperimentell: Trapezius MTRP and stretching
The central MTRP of the trapezius was treated as described above for the sternocleidomastoid.
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The sternocleidomastoid was treated with ischemic compression.
The patient's head was passively moved into contralateral rotation and the patient was asked to relax completely.
Sustained pressure was then applied to the sternocleidomastoid muscle until the pain threshold was reached.
During the application of pressure, pain decreases so the pressure was gradually increased over a duration of 1 minute.
The pressure was then reduced progressively.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pain intensity
Tidsramme: 4 weeks
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The Visual Analogue Scale (VAS)25 was used to rate the patients average pain intensity using a 0-10 scale (0=no pain, 10=the most severe pain).
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4 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The impact of headache (HIT-6)
Tidsramme: 4 weeks
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The Headache Impact Test (HIT-6) (Yang et al., 2011) provides an overall measure of the adverse impact of headaches.
This questionnaire consists of 6 items measuring the impact of pain on social functioning, role functioning, vitality, cognitive functioning and psychological distress, and provides a measure of the severity.
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4 weeks
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Disability (MIDAS)
Tidsramme: 4 weeks
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. Disability caused by migraine was assessed by the MIDAS questionnaire (Adenis Silva et al., 2008) based on 5 questions and the score obtained from the sum of the days lost due to headaches registered in the questions.
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4 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Calandre EP, Hidalgo J, Garcia-Leiva JM, Rico-Villademoros F. Trigger point evaluation in migraine patients: an indication of peripheral sensitization linked to migraine predisposition? Eur J Neurol. 2006 Mar;13(3):244-9. doi: 10.1111/j.1468-1331.2006.01181.x.
- Fernandez-de-las-Penas C, Dommerholt J. Myofascial trigger points: peripheral or central phenomenon? Curr Rheumatol Rep. 2014 Jan;16(1):395. doi: 10.1007/s11926-013-0395-2.
- Becker C, Brobert GP, Almqvist PM, Johansson S, Jick SS, Meier CR. Migraine incidence, comorbidity and health resource utilization in the UK. Cephalalgia. 2008 Jan;28(1):57-64. doi: 10.1111/j.1468-2982.2007.01469.x. Epub 2007 Nov 6.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
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
- ID005
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