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

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Myofascial release technique
conventional exercise therapy
Sponsored by
University of Social Welfare and Rehabilitation Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring myofascial release, cervicogenic headache, pain intensity, exercise therapy, pressure pain threshold

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Social Welfare and Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Myofascial release technique

conventional exercise therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

headache severity
Pain intensity using Visual Analogue Scale (VAS) were collected at base line and at the end of treatmen

Secondary Outcome Measures

headache frequency
number of headache days in the past week/month
headache duration
average number of hours that headaches lasted in the past week
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.

Full Information

First Posted
April 10, 2017
Last Updated
April 10, 2017
Sponsor
University of Social Welfare and Rehabilitation Science
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1. Study Identification

Unique Protocol Identification Number
NCT03113357
Brief Title
The Effect of Myofascial Release in Patients With Cervicogenic Headache
Acronym
RCT
Official Title
The Effect of Myofascial Release Technique on Headache Intensity,Duration,Frequency and Pressure Pain Threshold in Patients With Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Social Welfare and Rehabilitation Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
myofascial release, cervicogenic headache, pain intensity, exercise therapy, pressure pain threshold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myofascial release technique
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional exercise therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release technique
Other Intervention Name(s)
soft tissue release
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional exercise therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
headache severity
Description
Pain intensity using Visual Analogue Scale (VAS) were collected at base line and at the end of treatmen
Time Frame
one year
Secondary Outcome Measure Information:
Title
headache frequency
Description
number of headache days in the past week/month
Time Frame
one year
Title
headache duration
Description
average number of hours that headaches lasted in the past week
Time Frame
one year
Title
pressure pain threshold
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir M Arab, professor
Organizational Affiliation
University of Social Welfare and Rehabilitation Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Social Welfare and Rehabilitation Sciences
City
Tehran
State/Province
Islamic Republic of
ZIP/Postal Code
1985713831
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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The Effect of Myofascial Release in Patients With Cervicogenic Headache

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