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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03113357
Other study ID # 931672006
Secondary ID
Status Completed
Phase N/A
First received April 10, 2017
Last updated April 10, 2017
Start date January 2015
Est. completion date November 2016

Study information

Verified date April 2017
Source University of Social Welfare and Rehabilitation Science
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date November 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 15 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Iran, Islamic Republic of University of Social Welfare and Rehabilitation Sciences Tehran Islamic Republic of

Sponsors (1)

Lead Sponsor Collaborator
University of Social Welfare and Rehabilitation Science

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary headache severity Pain intensity using Visual Analogue Scale (VAS) were collected at base line and at the end of treatmen one year
Secondary headache frequency number of headache days in the past week/month one year
Secondary headache duration average number of hours that headaches lasted in the past week one year
Secondary 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. one year
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