NCT04376125

Brief Summary

The researchers will carry out a randomized experimental study. Participants in the experimental group will receive a treatment based on suboccipital inhibition technique in addition to conventional treatment. Participants in the control group will only receive the conventional treatment. The existence of significant differences in both groups will be analyzed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

February 24, 2019

Last Update Submit

May 1, 2020

Conditions

Keywords

tension headachesuboccipital inhibition

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analogue Scale for Pain

    a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "worst imaginable pain" (score of 10)

    immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start

Secondary Outcomes (1)

  • Change in Six-item Headache Impact Text

    immediately before starting the intervention and after the last session of the intervention, that is, 2 weeks from the start

Study Arms (2)

Suboccipital inhibition in tension headache

EXPERIMENTAL

Two groups of patients suffering from tension headache associated with cervicalgia are selected. The control group performs conventional therapy. The experimental group performs conventional therapy plus the technique of suboccipital inhibition

Other: Suboccipital inhibition in tension headache

study of results

ACTIVE COMPARATOR

We compared data from both groups

Other: Suboccipital inhibition in tension headache

Interventions

Deep maneuver of myofascial induction in the suboccipital muscles

Suboccipital inhibition in tension headachestudy of results

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pathology tension headache associated with cervicalgia

You may not qualify if:

  • pathology of nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cristina Blanco Ortega

León, 24001, Spain

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Cristina Blanco Ortega, physiotherap

    Universidad de León

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 24, 2019

First Posted

May 6, 2020

Study Start

February 1, 2019

Primary Completion

November 22, 2019

Study Completion

June 30, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations