Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief

Study Overview
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Brief Summary
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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
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This is an randomized clinical trial, double blind, comparing two interventions in women with migraine, whose diagnosis was confirmed by a neurologist.

Official Title
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Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief in Women With Migraine

Conditions
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Migraine Disorders

Intervention / Treatment
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* Other: PNF contract-relax
* Other: Static stretching


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PNF contract-relax<br>Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal. | Other: PNF contract-relax<br>* Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal.<br>|
| Experimental: Static stretching<br>Static stretching of neck muscles. | Other: Static stretching<br>* Static stretching of neck muscles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain change | Daily headache | Change from Baseline Pain at 8th - 10th week; Change from Baseline Pain at 12th - 14th week | 
| The global perception of change | Patient Global Impression of Change Scale | global perception of change at 12th - 14th week | 
| Feasibility for successful random allocation | successful random allocation of 30 patients during a 12-months period | 12 months | 
| Proportion of eligible patients randomly assigned for each group (target ≥70%) | the proportion of eligible patients randomly assigned for each group (target ≥70%) | 12 months | 
| Proportion of eligible patients who completed 30-day follow-up (target ≥95%) | the proportion of randomly assigned patients who completed 30-day follow-up after the end of the treatment (target ≥95%) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Medicine intake in migraine attacks | Daily headache | Change from Baseline Medicine intake at 8th - 10th week; Change from Baseline Medicine intake at 12th - 14th week | 
| Change in Adverse effects of the intervention | Daily headache | Change from Baseline adverse effects at 8th - 10th week; Change from Baseline adverse effects at 12th - 14th week | 
| Change in Neck mobility | Goniometer Cervical Range of Motion (CROM) | Change from Baseline neck mobility at 8th - 10th week; Change from Baseline neck mobility at 12th - 14th week | 
| Change in pressure pain threshold | Computerized Algometer | Change from Baseline pressure pain threshold at 8th - 10th week; Change from Baseline pressure pain threshold at 12th - 14th week | 
| Change in neck disability index | Questionnaire Neck disability index | Change from Baseline neck disability index at 8th - 10th week; Change from Baseline neck disability index at 12th - 14th week | 
| Change in severity of migraine-related disability | Questionnaire Migraine disability assessment | Change from Baseline Migraine disability assessment at 8th - 10th week; Change from Baseline Migraine disability assessment at 12th - 14th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine disorders, Muscle stretching exercises