Clinical Effects of Upper Cervical Translatoric Mobilization in Patients With Headache
Primary Purpose
Headache
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
UC-TSM
Sponsored by
About this trial
This is an interventional treatment trial for Headache focused on measuring Physiotherapy, Manual Therapy
Eligibility Criteria
Inclusion Criteria:
- Present a history of headache.
Exclusion Criteria:
- Receive cervical treatment in the previous month.
- Present red flags for headache.
- Present any contraindications to manual therapy.
- Current involvement in compensations.
Sites / Locations
- Unidad de Investigación en Fisioterapia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
UC-TSM
Control
Arm Description
Upper 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.
The control group receive no treatment intervention during 30 minutes (a similar time as the UC-TSM group).
Outcomes
Primary Outcome Measures
Headache intensity as measured by Visual Analog Scale
Secondary Outcome Measures
Cervical mobility as measured by cervical range of motion device (CROM)
Pressure pain threshold as measured by digital algometer (Somedic Farsta)
Temporomandibular joint mobility as measured by digital calipher (mouth opening)
Global Perceived Effect as measured by Global Perceived Effect Scale (-5 to +5 Likert Scale)
Immediate headache intensity changes as measured by Visual Analog Scale
Full Information
NCT ID
NCT02422862
First Posted
April 13, 2015
Last Updated
February 25, 2016
Sponsor
Universidad de Zaragoza
1. Study Identification
Unique Protocol Identification Number
NCT02422862
Brief Title
Clinical Effects of Upper Cervical Translatoric Mobilization in Patients With Headache
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
Physiotherapy, Manual Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UC-TSM
Arm Type
Experimental
Arm Description
Upper 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group receive no treatment intervention during 30 minutes (a similar time as the UC-TSM group).
Intervention Type
Other
Intervention Name(s)
UC-TSM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Headache intensity as measured by Visual Analog Scale
Time Frame
From Baseline to one month follow-up
Secondary Outcome Measure Information:
Title
Cervical mobility as measured by cervical range of motion device (CROM)
Time Frame
1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Title
Pressure pain threshold as measured by digital algometer (Somedic Farsta)
Time Frame
1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Title
Temporomandibular joint mobility as measured by digital calipher (mouth opening)
Time Frame
1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up
Title
Global Perceived Effect as measured by Global Perceived Effect Scale (-5 to +5 Likert Scale)
Time Frame
One month follow-up
Title
Immediate headache intensity changes as measured by Visual Analog Scale
Time Frame
1 minute Pre-Intervention, 1 minute Post-Intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Present a history of headache.
Exclusion Criteria:
Receive cervical treatment in the previous month.
Present red flags for headache.
Present any contraindications to manual therapy.
Current involvement in compensations.
Facility Information:
Facility Name
Unidad de Investigación en Fisioterapia
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29229055
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Effects of Upper Cervical Translatoric Mobilization in Patients With Headache
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