Migraine DisordersPNFNCT02549885
Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief
A study testing PNF contract-relax and Static stretching in people with Migraine Disorders, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- PNF contract-relax and Static stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Departamento de Fisioterapia da Universidade Federal de Pernambuco
Recife, Pernambuco, 50740-560
About this study
Official title: 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.
Read the detailed description
This is an randomized clinical trial, double blind, comparing two interventions in women with migraine, whose diagnosis was confirmed by a neurologist.
- Conditions
- Migraine Disorders
- Being tested
- PNF contract-relax, Static stretching
- Keywords
- Migraine disorders, Muscle stretching exercises
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF contract-relaxOther
Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal.
Static stretchingOther
Static stretching of neck muscles.
| Study group | Role | What they receive |
|---|---|---|
| PNF contract-relax | Experimental | Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal. Receives: Other: PNF contract-relax |
| Static stretching | Experimental | Static stretching of neck muscles. Receives: Other: Static stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain change
"Daily headache"
Measured: "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"
Measured: "global perception of change at 12th - 14th week"
Feasibility for successful random allocation
"successful random allocation of 30 patients during a 12-months period"
Measured: "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%)"
Measured: "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%)"
Measured: "12 months"
Secondary outcomes (6)
Change in Medicine intake in migraine attacks
"Daily headache"
Measured: "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
Measured: "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)"
Measured: "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"
Measured: "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"
Measured: "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"
Measured: "Change from Baseline Migraine disability assessment at 8th - 10th week"; "Change from Baseline Migraine disability assessment at 12th - 14th week"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DÉBORA WANDERLEY VILLELA, Universidade Federal de Pernambuco
- Investigators
- DÉBORA W VILLELA, MASTER, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549885
- Sponsor's protocol ID
- ECCR2015
- Acronym
- PNF
- Status last verified
- Mar 2018
- First submitted
- 10 Sep 2015
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Proprioceptive Neuromuscular Facilitation in Pain Relief in Women With Migraine
- ClinicalTrials.gov ID
- NCT02549885
- Acronym / sponsor ID
- PNF / ECCR2015
- Conditions
- Migraine Disorders
- Keywords
- Migraine disorders, Muscle stretching exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF contract-relax | Experimental | Other: PNF contract-relaxProprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal. |
| Static stretching | Experimental | Other: Static stretchingStatic stretching of neck muscles. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNF contract-relaxProprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal. | Other | PNF contract-relax |
| Static stretchingStatic stretching of neck muscles. | Other | Static stretching |
Primary outcome
Pain change
Time frame: "Change from Baseline Pain at 8th - 10th week"; "Change from Baseline Pain at 12th - 14th week"
"Daily headache"
The global perception of change
Time frame: "global perception of change at 12th - 14th week"
"Patient Global Impression of Change Scale"
Feasibility for successful random allocation
Time frame: "12 months"
"successful random allocation of 30 patients during a 12-months period"
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%)"
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%)"
6 secondary outcomes
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"
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"
Change in Neck mobility
Time frame: "Change from Baseline neck mobility at 8th - 10th week"; "Change from Baseline neck mobility at 12th - 14th week"
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"
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"
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DÉBORA W VILLELA, MASTER principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF contract-relax and Static stretching in people with Migraine Disorders, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain change (time frame: "Change from Baseline Pain at 8th - 10th week"; "Change from Baseline Pain at 12th - 14th week"). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.