NCT03113357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

April 10, 2017

Last Update Submit

April 10, 2017

Conditions

Keywords

myofascial releasecervicogenic headachepain intensityexercise therapypressure pain threshold

Outcome Measures

Primary Outcomes (1)

  • headache severity

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

    one year

Secondary Outcomes (3)

  • headache frequency

    one year

  • headache duration

    one year

  • pressure pain threshold

    one year

Study Arms (2)

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.

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.

Other: conventional exercise therapy

Interventions

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

Also known as: soft tissue release
Myofascial release technique

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.

conventional exercise therapy

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Social Welfare and Rehabilitation Sciences

Tehran, Islamic Republic of, 1985713831, Iran

Location

MeSH Terms

Conditions

Post-Traumatic HeadachePain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Amir M Arab, professor

    University of Social Welfare and Rehabilitation Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Amir Massoud Arab, University of Social Welfare and Rehabilitation Science

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

January 1, 2015

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations