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Clinical Trials/NCT02549885
NCT02549885
Completed
Not Applicable

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

Universidade Federal de Pernambuco1 site in 1 country30 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Migraine Disorders
Sponsor
Universidade Federal de Pernambuco
Enrollment
30
Locations
1
Primary Endpoint
Feasibility for successful random allocation
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
August 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

DÉBORA WANDERLEY VILLELA

Master

Universidade Federal de Pernambuco

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.

Outcomes

Primary Outcomes

Feasibility for successful random allocation

Time Frame: "12 months"

"successful random allocation of 30 patients during a 12-months period"

Pain change

Time Frame: "Change from Baseline Pain at 8th - 10th week"; "Change from Baseline Pain at 12th - 14th week"

"Daily headache"

The global perception of change

Time Frame: "global perception of change at 12th - 14th week"

"Patient Global Impression of Change Scale"

Proportion of eligible patients who completed 30-day follow-up (target ≥95%)

Time Frame: "12 months"

"the proportion of randomly assigned patients who completed 30-day follow-up after the end of the treatment (target ≥95%)"

Proportion of eligible patients randomly assigned for each group (target ≥70%)

Time Frame: "12 months"

"the proportion of eligible patients randomly assigned for each group (target ≥70%)"

Secondary Outcomes

  • Change in severity of migraine-related disability("Change from Baseline Migraine disability assessment at 8th - 10th week"; "Change from Baseline Migraine disability assessment at 12th - 14th week")
  • Change in Adverse effects of the intervention("Change from Baseline adverse effects at 8th - 10th week"; "Change from Baseline adverse effects at 12th - 14th week")
  • Change in Neck mobility("Change from Baseline neck mobility at 8th - 10th week"; "Change from Baseline neck mobility at 12th - 14th week")
  • Change in 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 Medicine intake in migraine attacks("Change from Baseline Medicine intake at 8th - 10th week"; "Change from Baseline Medicine intake at 12th - 14th week")
  • Change in pressure pain threshold("Change from Baseline pressure pain threshold at 8th - 10th week"; "Change from Baseline pressure pain threshold at 12th - 14th week")

Study Sites (1)

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