Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief

NCT02549885 | Completed

• 1 other identifier: ECCR2015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Keywords

Migraine disorders; Muscle stretching exercises

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• 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 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 pressure pain threshold

  "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

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

Study Arms (2)

PNF contract-relax

EXPERIMENTAL

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

Other: PNF contract-relax

Static stretching

EXPERIMENTAL

Static stretching of neck muscles.

Other: Static stretching

Interventions

PNF contract-relax OTHER

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

PNF contract-relax

Static stretching OTHER

Static stretching of neck muscles.

Static stretching

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Departamento de Fisioterapia da Universidade Federal de Pernambuco

Recife, Pernambuco, 50740-560, Brazil

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• DÉBORA W VILLELA, MASTER

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 15, 2015
• Study Start: April 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)