Clinical Effects of Upper Cervical Translatoric Mobilization in Patients With Headache
1 other identifier
interventional
162
1 country
1
Brief Summary
Frequently, headache is associated with disorders of the cervical spine, specially on the upper cervical spine. Therefore, restoration of the upper cervical mobility is considered fundamental for the treatment of headache. Manual therapy interventions seek to restore upper cervical mobility through a wide range of therapeutic procedures, including mobilization or manipulation techniques. Previous systematic reviews reported preliminary evidence for the application of upper cervical manual therapy techniques for the management of headache. The objective of this study is to study the effects of upper cervical translatoric spinal mobilization (UC-TSM) on headache intensity, cervical mobility and pressure pain threshold in subjects with headache. For this purpose, the investigators will conduct a randomized controlled trial. Volunteers with headache will participate in the study and will be randomly divided into control or treatment group. Treatment group will receive UC-TSM and the control group will receive no treatment. Headache intensity, cervical mobility, temporomandibular mobility and pressure pain thresholds (PPT) will be measured before and immediately after each treatment session (3 treatment sessions in one week period) and after one month follow-up. At this moment, global perceived effect will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
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, 2014
CompletedFirst Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFebruary 26, 2016
February 1, 2016
1.6 years
April 13, 2015
February 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Headache intensity as measured by Visual Analog Scale
From Baseline to one month follow-up
Secondary Outcomes (5)
Cervical mobility as measured by cervical range of motion device (CROM)
1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Pressure pain threshold as measured by digital algometer (Somedic Farsta)
1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Temporomandibular joint mobility as measured by digital calipher (mouth opening)
1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Global Perceived Effect as measured by Global Perceived Effect Scale (-5 to +5 Likert Scale)
One month follow-up
Immediate headache intensity changes as measured by Visual Analog Scale
1 minute Pre-Intervention, 1 minute Post-Intervention
Study Arms (2)
UC-TSM
EXPERIMENTALUpper cervical translatoric spinal mobilization (UC-TSM). UC-TSM is a physical therapy technique used to improve range of movement, consisting on a manual stretching of the cervical spine of the patient during 30 minutes.
Control
NO INTERVENTIONThe control group receive no treatment intervention during 30 minutes (a similar time as the UC-TSM group).
Interventions
Upper cervical translatoric spinal mobilization: a 30 minutes treatment consisting of 30" series of translatoric mobilizations of the upper cervical spine with 10" rest between sets. For that purpose, the patient is positioned in supine, with the cervical spine in neutral position. The therapist place a hand dorsally at the level of the vertebral arch of C1 with the metacarpophalangeal and radial border of the index finger. The other hand is placed posteriorly under the occiput, with the shoulder positioned anteriorly on the patient's forehead. The mobilization force is directed dorsally from the shoulder until the therapist feel a marked resistance and then apply slightly more pressure in order to perform a stretching mobilization.
Eligibility Criteria
You may qualify if:
- Present a history of headache.
You may not qualify if:
- Receive cervical treatment in the previous month.
- Present red flags for headache.
- Present any contraindications to manual therapy.
- Current involvement in compensations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unidad de Investigación en Fisioterapia
Zaragoza, Aragon, 50009, Spain
Related Publications (1)
Malo-Urries M, Tricas-Moreno JM, Estebanez-de-Miguel E, Hidalgo-Garcia C, Carrasco-Uribarren A, Cabanillas-Barea S. Immediate Effects of Upper Cervical Translatoric Mobilization on Cervical Mobility and Pressure Pain Threshold in Patients With Cervicogenic Headache: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):649-658. doi: 10.1016/j.jmpt.2017.07.007.
PMID: 29229055DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 21, 2015
Study Start
January 1, 2014
Primary Completion
August 1, 2015
Study Completion
January 1, 2016
Last Updated
February 26, 2016
Record last verified: 2016-02