The Effect of Myofascial Release in Patients With Cervicogenic Headache (RCT)

April 10, 2017 updated by: Amir Massoud Arab, University of Social Welfare and Rehabilitation Science

The Effect of Myofascial Release Technique on Headache Intensity,Duration,Frequency and Pressure Pain Threshold in Patients With Cervicogenic Headache

Cervicogenic headache (CeH) is a secondary and often unilateral that is known by referring pain from soft or hard cervical structures to occipital, temporal, frontal and sometimes pre-orbital regions. There is higher prevalence of cervical muscle tightness, assessed clinically in CeH patients and anatomically there are some fascial connections between sub-occipital muscles with vertebra of C2 and Dura-mater.Therefore fascial restriction in this region can limit the normal movement of muscles between fascial plates in different directions in sub-occipital region. The purpose of current study was to compare the effect of MFR Technique in the upper cervical region with common (Exs) on pain intensity, frequency, duration and Pressure Pain Threshold (PPT) of upper cervical joints in subjects with CeH.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cervicogenic headache (CeH) is a secondary and often unilateral that is known by referring pain from soft or hard cervical structures to occipital, temporal, frontal and sometimes pre-orbital regions(Becker, 2010). Its prevalence within the general population is about 0.4-2.5% and in women four times more than men(Racicki, Gerwin, DiClaudio, Reinmann, & Donaldson, 2013). It has been estimated that 15-20% of all chronic headaches include CeH (Racicki et al., 2013). According to reports, at a minimum about 7 million people travail from CeH that cause to waste many daily works and so decrease their performance strongly(Suijlekom, Lamé, Stomp-van den Berg, Kessels, & Weber, 2003). Based on last version of "Cervicogenic Headache International Study Group" a list including some clinical criteria as pain by cervical movement or inappropriate sustained positions, soft tissue stiffness, neck pain and limited cervical Range of Motion (ROM) has been mentioned for CeH. The best available studies has showed that the C2-3 zygapophysial joints are the most common source of CeH, accounting for about 70% of cases(Hall, Briffa, Hopper, & Robinson, 2010; Zito, Jull, & Story, 2006). One of the major problem is overlapping of CeH with other type headaches like migraine and tension type headache (TTH)(Yi, Cook, Hamill-Ruth, & Rowlingson, 2005) but it has been proven that the best clinical test with high sensitivity and specificity for diagnosing of CeH is upper cervical flexion-rotation test (FRT)(Amiri, Jull, & Bullock-Saxton, 2003; Bravo Petersen & Vardaxis, 2015). some investigations have linked CeH to painful dysfunction in the upper three cervical segments (C0-3)(Hall et al., 2007; Ogince, Hall, Robinson, & Blackmore, 2007). Jull and et al at 1999 had noted that there is higher prevalence of cervical muscle tightness, assessed clinically in CeH patients(G Jull, Barrett, Magee, & Ho, 1999; Zito et al., 2006). Nevertheless anatomically, there are some fascial connections between sub-occipital muscles with vertebra of C2 and Dura-mater (Robert Schleip, Jäger, & Klingler, 2012). It has been assumed that fascial limitations in one region of the body cause undue stress in another regions of the body due to fascial continuity, Therefore fascial restriction in this region can limit the normal movement of muscles between fascial plates in different directions in sub-occipital region(Ajimsha, Al-Mudahka, & Al-Madzhar, 2015; Robert Schleip, 2003). Recent Fascia Research Congresses (FRC) explained fascia as a 'soft tissue component of the connective tissue system that percolate the human body(Langevin & Huijing, 2009) and is a part of body tensional force transmission system(R Schleip, Findley, Chaitow, & Huijing, 2012). Myofascial Release (MFR) is a therapeutic technique that uses gentle pressure and stretching (in both forms of direct and indirect approaches) intended to restore decrease pain, optimized length, , and facilitate the release of fascial restrictions caused by injury, stress, repetitive use, and etc (J. F. Barnes, 1990; Robert Schleip, 2003). There are some studies about MFR and its effects that include: increase extensibilities of soft tissues, increase ROM, Improve joint biomechanics, decrease pain and muscles tone significantly (Ajimsha, 2011; Tozzi, Bongiorno, & Vitturini, 2011). Although; a lot of remedies as physiotherapy, electrotherapy, exercises therapy and spinal mobilization are used for cervicogenic headache (GA Jull & Stanton, 2005; Pöllmann, Keidel, & Pfaffenrath, 1997) but it has not been studied specifically about sub-occipital MFR for CeH. Therefor the purpose of current study was to compare the effect of MFR Technique in the upper cervical region with common (Exs) on pain intensity, frequency, duration and Pressure Pain Threshold (PPT) of upper cervical joints in subjects with CeH.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Islamic Republic of
      • Tehran, Islamic Republic of, Iran, Islamic Republic of, 1985713831
        • University of Social Welfare and Rehabilitation Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neck pain with referring unilateral pain to sub-occipital region.
  • The pain and limitation of C1-C2 rotation with craniocervical FRT.
  • Intensifying of Headache by manual pressure to upper cervical muscles and joints.
  • Headache frequency of at least one per week a period of previous 6 months

Exclusion Criteria:

  • Bilateral headaches (typifying tension headache).
  • Intolerance to craniocervical FRT.
  • Presence of autonomic system symptoms like vertigo, dizziness and visual impairment.
  • Severe specific neck pain as disk herniation, canal stenosis and cervical spondylosis.
  • Any condition that might contraindicate myofascial release technique in upper cervical region.
  • Physiotherapy for headache in the previous 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Myofascial release technique
Subjects lied down in supine with knee flexion. Therapist seated on a stool at the head of the table. Elbows and supinated forearms on the table. Asked the client to lift their head off the table. Position the tips of the first three fingers into the soft tissue immediately inferior to the arc of atlas. The fingers are stabilized in a flexed position - around 45° at the MP and PIP joints. The subject is asked to rest their head back down so the fingertips are in the sub-occipital soft tissues and the finger pads rest firmly against the inferior aspect of the atlas. Once the position is perceived to be comfortable, a series of soft tissue responses will occur, characterized by local softening sensations followed by an increase in the weight of the head.
Other: Myofascial release technique
myofascial release technique take along about 3 minutes. This phase repeated 3 times in each session. At the end, for more release, sub-occipital traction will commence. The subject lies supine with head supported and therapist places the three middle fingers just caudal to the nuchal line, lifts the finger tips upward resting the hands on the treatment table, and then applies a gentle cranial pull, causing a long axis extension. The procedure is performed for 2 to 3 minutes. Subjects in each group received ten physical therapy treatment sessions. Treatment frequency was six times per week for MFR group and every day for exercise group which three times per week have been come to clinical center for checking of exercise by physiotherapist
Other Names:
  • soft tissue release
Experimental: conventional exercise therapy
Craniocervical flexion exercises, performed in supine lying, aimed to target the deep neck flexor muscles. Then they trained to be able to hold progressively increasing ranges of craniocervical flexion using feedback from an airfilled pressure sensor placed behind the neck. The muscles of the scapula, particularly the serratus anterior and lower trapezius, were trained using inner range holding exercises of scapular adduction and retraction, practiced initially in the prone lying position. The subjects were trained to sit with a natural lumbar lordosis while gently adducting and retracting their scapulas and gently flexed their cranio-cervical spine to facilitate the deep neck flexors.
Other: conventional exercise therapy
All exercises were performed to a count of 7 seconds and subjects were instructed to perform all exercises daily, 15 repetitions each (twice a day). Treatment frequency was every day for exercise group which three times per week have been come to "clinical center" for checking of exercise by physiotherapist. They also could be taught active muscle stretching exercises to address any muscle tightness assessed to be present.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
headache severity
Time Frame: one year
Pain intensity using Visual Analogue Scale (VAS) were collected at base line and at the end of treatmen
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
headache frequency
Time Frame: one year
number of headache days in the past week/month
one year
headache duration
Time Frame: one year
average number of hours that headaches lasted in the past week
one year
pressure pain threshold
Time Frame: one year
A pressure threshold algometer was used to measure the pain pressure threshold of a Trigger point of the vastus lateralis muscle before treatment and the end of of transverse and spinous process of C1 and C2 vertebrae before and after 10 treatmen session.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Social Welfare and Rehabilitation Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amir M Arab, professor, University of Social Welfare and Rehabilitation Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 931672006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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