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Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief (PNF)

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PNF contract-relax
Static stretching
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Migraine Disorders focused on measuring Migraine disorders, Muscle stretching exercises

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Departamento de Fisioterapia da Universidade Federal de Pernambuco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PNF contract-relax

Static stretching

Arm Description

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

Static stretching of neck muscles.

Outcomes

Primary Outcome Measures

Pain change
"Daily headache"
The global perception of change
"Patient Global Impression of Change Scale"
Feasibility for successful random allocation
"successful random allocation of 30 patients during a 12-months period"
Proportion of eligible patients randomly assigned for each group (target ≥70%)
"the proportion of eligible patients randomly assigned for each group (target ≥70%)"
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%)"

Secondary Outcome Measures

Change in Medicine intake in migraine attacks
"Daily headache"
Change in Adverse effects of the intervention
Daily headache
Change in Neck mobility
Goniometer "Cervical Range of Motion (CROM)"
Change in pressure pain threshold
"Computerized Algometer"
Change in neck disability index
Questionnaire "Neck disability index"
Change in severity of migraine-related disability
Questionnaire "Migraine disability assessment"

Full Information

First Posted
September 10, 2015
Last Updated
March 13, 2018
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02549885
Brief Title
Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief
Acronym
PNF
Official Title
Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief in Women With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Migraine disorders, Muscle stretching exercises

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PNF contract-relax
Arm Type
Experimental
Arm Description
Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal.
Arm Title
Static stretching
Arm Type
Experimental
Arm Description
Static stretching of neck muscles.
Intervention Type
Other
Intervention Name(s)
PNF contract-relax
Intervention Description
Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal.
Intervention Type
Other
Intervention Name(s)
Static stretching
Intervention Description
Static stretching of neck muscles.
Primary Outcome Measure Information:
Title
Pain change
Description
"Daily headache"
Time Frame
"Change from Baseline Pain at 8th - 10th week"; "Change from Baseline Pain at 12th - 14th week"
Title
The global perception of change
Description
"Patient Global Impression of Change Scale"
Time Frame
"global perception of change at 12th - 14th week"
Title
Feasibility for successful random allocation
Description
"successful random allocation of 30 patients during a 12-months period"
Time Frame
"12 months"
Title
Proportion of eligible patients randomly assigned for each group (target ≥70%)
Description
"the proportion of eligible patients randomly assigned for each group (target ≥70%)"
Time Frame
"12 months"
Title
Proportion of eligible patients who completed 30-day follow-up (target ≥95%)
Description
"the proportion of randomly assigned patients who completed 30-day follow-up after the end of the treatment (target ≥95%)"
Time Frame
"12 months"
Secondary Outcome Measure Information:
Title
Change in Medicine intake in migraine attacks
Description
"Daily headache"
Time Frame
"Change from Baseline Medicine intake at 8th - 10th week"; "Change from Baseline Medicine intake at 12th - 14th week"
Title
Change in Adverse effects of the intervention
Description
Daily headache
Time Frame
"Change from Baseline adverse effects at 8th - 10th week"; "Change from Baseline adverse effects at 12th - 14th week"
Title
Change in Neck mobility
Description
Goniometer "Cervical Range of Motion (CROM)"
Time Frame
"Change from Baseline neck mobility at 8th - 10th week"; "Change from Baseline neck mobility at 12th - 14th week"
Title
Change in pressure pain threshold
Description
"Computerized Algometer"
Time Frame
"Change from Baseline pressure pain threshold at 8th - 10th week"; "Change from Baseline pressure pain threshold at 12th - 14th week"
Title
Change in neck disability index
Description
Questionnaire "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"
Title
Change in severity of migraine-related disability
Description
Questionnaire "Migraine disability assessment"
Time Frame
"Change from Baseline Migraine disability assessment at 8th - 10th week"; "Change from Baseline Migraine disability assessment at 12th - 14th week"

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DÉBORA W VILLELA, MASTER
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departamento de Fisioterapia da Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740-560
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief

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