Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief

Migraine Disorders Clinical Trial

— PNF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549885
• Other study ID #: ECCR2015
• Status: Completed
• Phase: N/A
• First received: September 10, 2015
• Last updated: March 13, 2018
• Start date: April 2016
• Est. completion date: August 2017

Study information

• Verified date: March 2018
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Other:
• PNF contract-relax
Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal.
• Static stretching
Static stretching of neck muscles.

Locations

Country	Name	City	State
Brazil	Departamento de Fisioterapia da Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain change	"Daily headache"	"Change from Baseline Pain at 8th - 10th week"; "Change from Baseline Pain at 12th - 14th week"
Primary	The global perception of change	"Patient Global Impression of Change Scale"	"global perception of change at 12th - 14th week"
Primary	Feasibility for successful random allocation	"successful random allocation of 30 patients during a 12-months period"	"12 months"
Primary	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"
Primary	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	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"
Secondary	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"
Secondary	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"
Secondary	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"
Secondary	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"
Secondary	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"