- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04001868
Sub Occipital Inhibition Technique on Postural Balance
December 18, 2019 updated by: SERGIO MONTERO NAVARRO, Cardenal Herrera University
Immediate Effect of Sub Occipital Inhibition Technique on Postural Balance: Stabilometric Study.
In the present study the investigators want to verify if the inhibition of the suboccipital muscles improves the postural balance in subjects with cervical pain objectified by stabilometry.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Valencia
-
Moncada, Valencia, Spain, 46113
- CEU Cardenal Herrera University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals who suffer neck pain for at least 3 months
- Come to receive physiotherapy treatment at Clinica Osteomed (NRS: 8415-CV), Elche, Alicante, Spain.
- Age between 18 and 65 years old.
- Sign the informed consent.
Exclusion Criteria:
- Suffering or having suffered pathologies of the postural control system (postural sensors, central nervous system or locomotor system)
- Presenting deformities or orthopedic injuries in the lower limbs or rachis
- Presenting pain at the moment of study
- Present contraindications to the intervention under study
- Have received physiotherapy treatment in the last six months
- Have undergone surgical treatment of any kind.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
Application of the sub occipital inhibition technique.
|
With the patient in the supine position and the therapist sitting at the head of the bed with the elbows resting on its surface.
The therapist palpates the cervical spinous processes and slides the fingers upwards until contacting the posterior projection of the posterior arch of the atlas.
Then, flexing the metacarpophalangeal at 90 degrees slowly raises the skull.
The therapist's hands should remain together and the base of the skull should rest on his palms pressing with the index, middle and ring fingers of each hand in a sustained manner, but without causing pain.
This pressure must be maintained during 4 minutes.
|
Placebo Comparator: Placebo Group
Hand contact in the sub occipital region without executing any technique.
|
A superficial contact in the same area as the intervention, to rule out the exteroceptive effect associated with the therapist's contact.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surface of the ellipse open eyes
Time Frame: Postintervention immediate
|
Determines the surface of the ellipse formed from the oscillations in the X and Y coordinates with open eyes.
The measurement is made using a stabilometric platform with 4 pressure sensors per square centimeter.
The software of the stabilometric platform collects 40 measurements per second through its pressure sensors, calculating the position of the projection of the center of gravity on the ground 40 times every second.
The described variable evaluates the surface of the ellipse that contains the successive points of the displacement of the projection of the center of gravity in the ground during the standarized time for the stabilometric recording (51.2 seconds).
It is a unique value, measured in a single moment.
If the ellipse formed is larger, it implies a greater amplitude of the displacement of the center of gravity, and therefore a lower equilibrium capacity.
Interval: 0-1000 (mm2).
|
Postintervention immediate
|
Surface of the ellipse closed eyes
Time Frame: Postintervention immediate
|
Determines the surface of the ellipse formed from the oscillations in the X and Y coordinates with closed eyes.
The measurement is made using a stabilometric platform with 4 pressure sensors per square centimeter.
The software of the stabilometric platform collects 40 measurements per second through its pressure sensors, calculating the position of the projection of the center of gravity on the ground 40 times every second.
The described variable evaluates the surface of the ellipse that contains the successive points of the displacement of the projection of the center of gravity in the ground during the standarized time for the stabilometric recording (51.2 seconds).
It is a unique value, measured in a single moment.
If the ellipse formed is larger, it implies a greater amplitude of the displacement of the center of gravity, and therefore a lower equilibrium capacity.
Interval: 0-1000 (mm2).
|
Postintervention immediate
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean of the oscillation on the X axis and on the Y axis.
Time Frame: Preintervention and Postintervention immediate.
|
It assesses the lateral and anteroposterior oscillation of the projection on the floor of the center of gravity during the 51 seconds of the stabilometric record.
Interval: 0-50 (mm).
Greater oscillation implies less postural balance.
|
Preintervention and Postintervention immediate.
|
Speed of the oscillation on the X axis and on the Y axis
Time Frame: Preintervention and Postintervention immediate.
|
Determines the speed with which the projection of the center of gravity moves in lateral and anteroposterior direction during the 51 seconds of the stabilometric record.
Interval: 0-10 (mm/s).
Greater speed implies less postural balance.
|
Preintervention and Postintervention immediate.
|
Average speed of the oscillation
Time Frame: Preintervention and Postintervention immediate.
|
Determines the average speed with which the projection of the center of gravity moves in lateral and anteroposterior direction during the 51 seconds of the stabilometric record.
Interval: 0-10 (mm/s).
Greater speed implies less postural balance.
|
Preintervention and Postintervention immediate.
|
Length of oscillation
Time Frame: Preintervention and Postintervention immediate.
|
Determine the length of movement described by the projection on the ground of the center of gravity during the stabilometric measurement.
Interval: 0-1000 (mm).
Greater length implies less postural balance.
|
Preintervention and Postintervention immediate.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2019
Primary Completion (Actual)
July 3, 2019
Study Completion (Actual)
December 18, 2019
Study Registration Dates
First Submitted
June 19, 2019
First Submitted That Met QC Criteria
June 26, 2019
First Posted (Actual)
June 28, 2019
Study Record Updates
Last Update Posted (Actual)
December 19, 2019
Last Update Submitted That Met QC Criteria
December 18, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEU UCH 212
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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