Clinical Effects of Upper Cervical Translatoric Mobilization in Patients With Headache

Headache Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422862
• Other study ID #: MMU.01.001
• Status: Completed
• Phase: N/A
• First received: April 13, 2015
• Last updated: February 25, 2016
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Departamento de Fisiatría y Enfermería. Universidad de Zaragoza
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache

Intervention

Other:
• UC-TSM
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.

Locations

Country	Name	City	State
Spain	Unidad de Investigación en Fisioterapia	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache intensity as measured by Visual Analog Scale		From Baseline to one month follow-up	Yes
Secondary	Cervical mobility as measured by cervical range of motion device (CROM)		1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up	Yes
Secondary	Pressure pain threshold as measured by digital algometer (Somedic Farsta)		1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up	Yes
Secondary	Temporomandibular joint mobility as measured by digital calipher (mouth opening)		1 minute Pre-Intervention, 1 minute Post-Intervention, One month follow-up	Yes
Secondary	Global Perceived Effect as measured by Global Perceived Effect Scale (-5 to +5 Likert Scale)		One month follow-up	Yes
Secondary	Immediate headache intensity changes as measured by Visual Analog Scale		1 minute Pre-Intervention, 1 minute Post-Intervention	Yes