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Completed

NCT Number: NCT02549885

Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Departamento de Fisioterapia da Universidade Federal de Pernambuco

Recife, Pernambuco, 50740-560, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PNF contract-relax

Other

Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal.

Static Stretching

Other

Static stretching of neck muscles.

Primary outcomes

  1. Pain change

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

    "Daily headache"

  2. The global perception of change

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

    "Patient Global Impression of Change Scale"

  3. Feasibility for successful random allocation

    Time frame: "12 months"

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

  4. 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%)"

  5. 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%)"

Secondary outcomes

  1. Change in Medicine intake in migraine attacks

    Time frame: "Change from Baseline Medicine intake at 8th - 10th week"; "Change from Baseline Medicine intake at 12th - 14th week"

    "Daily headache"

  2. Change in Adverse effects of the intervention

    Time frame: "Change from Baseline adverse effects at 8th - 10th week"; "Change from Baseline adverse effects at 12th - 14th week"

    Daily headache

  3. Change in Neck mobility

    Time frame: "Change from Baseline neck mobility at 8th - 10th week"; "Change from Baseline neck mobility at 12th - 14th week"

    Goniometer "Cervical Range of Motion (CROM)"

  4. Change in pressure pain threshold

    Time frame: "Change from Baseline pressure pain threshold at 8th - 10th week"; "Change from Baseline pressure pain threshold at 12th - 14th week"

    "Computerized Algometer"

  5. Change in neck disability index

    Time frame: "Change from Baseline neck disability index at 8th - 10th week"; "Change from Baseline neck disability index at 12th - 14th week"

    Questionnaire "Neck disability index"

  6. Change in severity of migraine-related disability

    Time frame: "Change from Baseline Migraine disability assessment at 8th - 10th week"; "Change from Baseline Migraine disability assessment at 12th - 14th week"

    Questionnaire "Migraine disability assessment"

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Acronym: PNF

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2015
Registry last updated
Mar 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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