NCT02422862

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

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

April 13, 2015

Last Update Submit

February 25, 2016

Conditions

Keywords

PhysiotherapyManual Therapy

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

EXPERIMENTAL

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.

Other: UC-TSM

Control

NO INTERVENTION

The control group receive no treatment intervention during 30 minutes (a similar time as the UC-TSM group).

Interventions

UC-TSMOTHER

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.

UC-TSM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations