NCT02195648

Brief Summary

The main objective of this study is to determine the effects caused in neck movement, neck pain, headache in patients with tension type headache and cervicogenic headache after application of sub-occipital muscle inhibition technique associated with interferential electrotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

First Submitted

Initial submission to the registry

July 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

July 15, 2014

Last Update Submit

April 26, 2018

Conditions

Tension-Type Headache

Keywords

Tension-Type HeadachePhysical Therapy ModalitiesMusculoskeletal ManipulationsSub-occipital muscle inhibition technique

Outcome Measures

Primary Outcomes (2)

  • Pain

    Our primary outcome will consist of changes at each session in self-reported pain, which will be measured with a visual analogic scale (VAS).

    Pain will be assessed at baseline, before and after each session (twice a week for 4 weeks)

  • Anxiety

    Anxiety will be assessed with the State-Trait Anxiety Inventory. This questionnaire is designed for the self-assessment of anxiety (Cronbach's α for this scale ranges from .83 to .92).

    STAI will be assessed at baseline and after 4 weeks.

Secondary Outcomes (6)

  • Headache Disability

    HDI will be assessed at baseline and after 4 weeks.

  • Headache Impact Test

    HIT-6 will be assessed at baseline and after 4 weeks.

  • Range of Motion

    ROM will be assessed at baseline and after 4 weeks.

  • Neck Disability Index

    NDI will be assessed at baseline and after 4 weeks.

  • SF-36 Health Survey

    SF-36 will be assessed at baseline and after 4 weeks.

  • +1 more secondary outcomes

Study Arms (2)

Suboccipital inhibition

EXPERIMENTAL

The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles.

Other: Suboccipital inhibition

Control

NO INTERVENTION

No intervention will be done to the participants during the study. After study completion, the participants will be offered to receive the therapy.

Interventions

Suboccipital inhibitionOTHER

Experimental: Suboccipital inhibition The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles.

Suboccipital inhibition

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with tension type headache
  • In prophylactic regimen and with medical control

You may not qualify if:

  • Patients with neurological or cognitive impairments that prevent understanding the questionnaires
  • Patients diagnosed with other types of headaches
  • Patients who have not signed the informed consent document

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio de Murcia

Murcia, Guadalupe, 30107, Spain

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Javier Meroño-Gallut, PhD

    Universidad Católica San Antonio de Murcia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded to group allocation. Additionally, analysis blinding will be performed to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Diplomado en Fisioterapia

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 21, 2014

Study Start

February 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

April 30, 2018

Record last verified: 2018-04

Locations

ES(1)