Clinical trial NCT02549885: Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief
Official title: Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief in Women With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorders
Keywords: Migraine disorders
Muscle stretching exercises
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the contract-relax technique of proprioceptive neuromuscular facilitation, and the static stretching exercise are effective in reducing the frequency, intensity and duration of headache and in improving the perception of quality of life in women with migraine.

Detailed description: This is an randomized clinical trial, double blind, comparing two interventions in women with migraine, whose diagnosis was confirmed by a neurologist.

Eligibility criteria: Inclusion Criteria:

* Age between 18and 40 years
* Clinical diagnosis of migraine
* Participants with at least one day with acute migraine per month, with attacks lasting 4-72 hours.

Exclusion Criteria:

* Obesity type I, II or III, according to the classification of Body Mass Index.
* Pregnancy, lactation or both.
* Presence of meningitis, demyelinating diseases, cerebral aneurysm, intracranial hypertension, myopathies, myelopathy, fibromyalgia, symptomatic neck disc herniation, rheumatoid arthritis and history of tumors in the brain or spine.
* Participants who performed other manual therapeutic interventions or other physical therapy modalities in the head or neck during the survey period.
* Participants who have daily prophylactic medication for migraine.

Primary outcomes:
measure: Pain change
timeFrame: "Change from Baseline Pain at 8th - 10th week"; "Change from Baseline Pain at 12th - 14th week"
measure: The global perception of change
timeFrame: "global perception of change at 12th - 14th week"
measure: Feasibility for successful random allocation
timeFrame: "12 months"
measure: Proportion of eligible patients randomly assigned for each group (target ≥70%)
timeFrame: "12 months"
measure: Proportion of eligible patients who completed 30-day follow-up (target ≥95%)
timeFrame: "12 months"
Secondary outcomes:
measure: Change in Medicine intake in migraine attacks
timeFrame: "Change from Baseline Medicine intake at 8th - 10th week"; "Change from Baseline Medicine intake at 12th - 14th week"
measure: Change in Adverse effects of the intervention
timeFrame: "Change from Baseline adverse effects at 8th - 10th week"; "Change from Baseline adverse effects at 12th - 14th week"
measure: Change in Neck mobility
timeFrame: "Change from Baseline neck mobility at 8th - 10th week"; "Change from Baseline neck mobility at 12th - 14th week"
measure: Change in pressure pain threshold
timeFrame: "Change from Baseline pressure pain threshold at 8th - 10th week"; "Change from Baseline pressure pain threshold at 12th - 14th week"
measure: Change in neck disability index
timeFrame: "Change from Baseline neck disability index at 8th - 10th week"; "Change from Baseline neck disability index at 12th - 14th week"
measure: Change in severity of migraine-related disability
timeFrame: "Change from Baseline Migraine disability assessment at 8th - 10th week"; "Change from Baseline Migraine disability assessment at 12th - 14th week"
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Departamento de Fisioterapia da Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: DÉBORA W VILLELA, MASTER
role: PRINCIPAL_INVESTIGATOR
References: