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Sub Occipital Inhibition Technique on Postural Balance

Primary Purpose

Movement Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Suboccipital inhibition
Placebo technique
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Movement Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ceu Cardenal Herrera University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Placebo Group

Arm Description

Application of the sub occipital inhibition technique.

Hand contact in the sub occipital region without executing any technique.

Outcomes

Primary Outcome Measures

Surface of the ellipse open eyes
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).
Surface of the ellipse closed eyes
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).

Secondary Outcome Measures

Mean of the oscillation on the X axis and on the Y axis.
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.
Speed of the oscillation on the X axis and on the Y axis
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.
Average speed of the oscillation
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.
Length of oscillation
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.

Full Information

First Posted
June 19, 2019
Last Updated
December 18, 2019
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT04001868
Brief Title
Sub Occipital Inhibition Technique on Postural Balance
Official Title
Immediate Effect of Sub Occipital Inhibition Technique on Postural Balance: Stabilometric Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Simple blind with evaluator blinded strategy.
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Application of the sub occipital inhibition technique.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Hand contact in the sub occipital region without executing any technique.
Intervention Type
Procedure
Intervention Name(s)
Suboccipital inhibition
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo technique
Intervention Description
A superficial contact in the same area as the intervention, to rule out the exteroceptive effect associated with the therapist's contact.
Primary Outcome Measure Information:
Title
Surface of the ellipse open eyes
Description
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).
Time Frame
Postintervention immediate
Title
Surface of the ellipse closed eyes
Description
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).
Time Frame
Postintervention immediate
Secondary Outcome Measure Information:
Title
Mean of the oscillation on the X axis and on the Y axis.
Description
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.
Time Frame
Preintervention and Postintervention immediate.
Title
Speed of the oscillation on the X axis and on the Y axis
Description
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.
Time Frame
Preintervention and Postintervention immediate.
Title
Average speed of the oscillation
Description
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.
Time Frame
Preintervention and Postintervention immediate.
Title
Length of oscillation
Description
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.
Time Frame
Preintervention and Postintervention immediate.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ceu Cardenal Herrera University
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.uchceu.es
Description
The University CEU Cardenal Herrera is the first private university in the Valencia Community. It belongs to the Foundation San Pablo - CEU and is the leading educational organization in Spain with three Universities all over Spain

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Sub Occipital Inhibition Technique on Postural Balance

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