Effect of drug therapy in the treatment of migraine

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-6kvx74
• Date of registration: 26/04/2012
• Primary sponsor: Faculdade de Medicina de Ribeirão preto da Universidade de São Paulo - Brazil
• Public title: Effect of drug therapy in the treatment of migraine
• Scientific title: Additional effect of physical therapy to drug treatment in reducing the intensity and frequency of migraine - a randomized controlled trial - ADERE: ADditional Effect of physical therapy to drug treatment in REducing the intensity and frequency of migraine - a randomized controlled trial
• Date of first enrolment: 01/11/2011
• Target sample size: 50
• Recruitment status: not yet recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-6kvx74/
• Study design: Clinical Trial, two-arm, single blinded trial Randomized Controlled, Phase Three.

Countries of recruitment

Brazil

Contacts

• Name: Maria Gonçalves
• Affiliation: Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

• Name: Débora Bevilaqua-Grossi
• Affiliation: Faculdade de Medicina de Ribeirão preto da Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Will be included 50 individuals with migraine, female, aged between 18 and 55. Will be considered only patients with at least two attacks and a maximum of 12 days of pain per month, with disease duration longer than one year, they are only in ambulatory treatment with amitriptyline up to 25 mg for at least 3 months.

Exclusion criteria: Will be excluded women with diagnoses of other concurrent headache diagnosis of migraine, history of cervical trauma and face, with uncontrolled systemic diseases affecting the musculoskeletal system, peripheral nervous system diseases, which have physical therapy in the last one year specific to region or craniocervical posture and have some clinical contraindication to the use of amitriptyline as cardiac arrhythmias, glaucoma and epilepsy.

Age minimum: 18Y
Age maximum: 55Y
Gender: F

Health Condition(s) or Problem(s) studied

Migraine without aura, myofascial pain syndromes, Limitations of the Cervical Range of Motion
C10.228.140.546.399.750.450
C05.651.550

Intervention(s)

Group of drugs: 25 volunteers will be instructed to taken orally (25 mg) of amitriptyline at night for two
months and will be allowed to use up to 600mg of Ibuprofen in cases of crisis stronger.

Group Therapy and medication: 25 volunteers will be instructed to take oral (25 mg) of amitriptyline to night for two months and will be allowed the use of Ibuprofen up to 600mg in cases of crisis stronger. And they will be subjected to two weekly sessions of physiotherapy (training respiratóriodiagramático, pompage, slip and release and myofascial digit compression) for eight weeks during
45 minutes, totaling 16 sessions.
Guidance will be made to the Group and medication Physiotherapy on behavior changes, how to avoid bad postures during activities of daily living.

Primary Outcome(s)

Reduced Frequency (in days) and intensity (in hours) of by Migraine headache diary.

Secondary Outcome(s)

Increase in neck range of motion in degrees using the Cervical Range of Motion (CROM).

Increased pressure pain threshold in kg in muscle in craniofacial demonstrated displey pressure algometer.

Secondary ID(s)

14027/2010

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) - Brazil

Secondary Sponsor(s)

Departamento de Biomecânica Medicina e Reabilitação do Aparelho Locomotor. - Brazil