Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief (PNF)

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Other: PNF contract-relax; Other: Static stretching

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50740-560
      • Departamento de Fisioterapia da Universidade Federal de Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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"

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Principal Investigator: DÉBORA W VILLELA, MASTER, Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: September 10, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Migraine disorders; Muscle stretching exercises
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: ECCR2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO