Cervicogenic HeadacheRCTNCT03113357
The Effect of Myofascial Release in Patients With Cervicogenic Headache
A study testing Myofascial release technique and conventional exercise therapy in people with Cervicogenic Headache, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Myofascial release technique and conventional exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIran
- Study dates
- Jan 2015to Nov 2016
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
University of Social Welfare and Rehabilitation Sciences
Tehran, Islamic Republic of, 1985713831
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- Myofascial release technique, conventional exercise therapy
- Keywords
- myofascial release, cervicogenic headache, pain intensity, exercise therapy, pressure pain threshold
- Medical subject headings
- Post-Traumatic Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial release techniqueOther
Also called soft tissue release
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
conventional exercise therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial release technique | Experimental | 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. Receives: Other: Myofascial release technique |
| conventional exercise therapy | Experimental | 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. Receives: Other: conventional exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
headache severity
Pain intensity using Visual Analogue Scale (VAS) were collected at base line and at the end of treatmen
Measured: one year
Secondary outcomes (3)
headache frequency
number of headache days in the past week/month
Measured: one year
headache duration
average number of hours that headaches lasted in the past week
Measured: one year
pressure pain threshold
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startJan 2015
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Massoud Arab, University of Social Welfare and Rehabilitation Science
- Investigators
- Amir M Arab, professor, Principal investigator, University of Social Welfare and Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113357
- Sponsor's protocol ID
- 931672006
- Acronym
- RCT
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myofascial Release Technique on Headache Intensity,Duration,Frequency and Pressure Pain Threshold in Patients With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT03113357
- Acronym / sponsor ID
- RCT / 931672006
- Conditions
- Cervicogenic Headache
- Keywords
- myofascial release, cervicogenic headache, pain intensity, exercise therapy, pressure pain threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial release technique | Experimental | Other: Myofascial release techniqueSubjects 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. |
| conventional exercise therapy | Experimental | Other: conventional exercise therapyCraniocervical 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. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Myofascial release techniqueAlso: soft tissue releasemyofascial 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 | Myofascial release technique |
| conventional exercise therapyAll 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. | Other | conventional exercise therapy |
Primary outcome
headache severity
Time frame: one year
Pain intensity using Visual Analogue Scale (VAS) were collected at base line and at the end of treatmen
3 secondary outcomes
headache frequency
Time frame: one year
headache duration
Time frame: one year
pressure pain threshold
Time frame: one year
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 13 Apr 2017.
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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.
Amir M Arab, professor principal investigator
University of Social Welfare and Rehabilitation Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release technique and conventional exercise therapy in people with Cervicogenic Headache, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
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 4 inclusion and 6 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 13 Apr 2017. 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 Iran. 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?
headache severity (time frame: one year). 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 13 Apr 2017.