NCT04001868

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 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

June 19, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

July 3, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

Same day

First QC Date

June 19, 2019

Last Update Submit

December 18, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    Postintervention immediate

  • 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).

    Postintervention immediate

Secondary Outcomes (4)

  • Mean of the oscillation on the X axis and on the Y axis.

    Preintervention and Postintervention immediate.

  • Speed of the oscillation on the X axis and on the Y axis

    Preintervention and Postintervention immediate.

  • Average speed of the oscillation

    Preintervention and Postintervention immediate.

  • Length of oscillation

    Preintervention and Postintervention immediate.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Application of the sub occipital inhibition technique.

Procedure: Suboccipital inhibition

Placebo Group

PLACEBO COMPARATOR

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

Procedure: Placebo technique

Interventions

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.

Experimental Group

A superficial contact in the same area as the intervention, to rule out the exteroceptive effect associated with the therapist's contact.

Placebo Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ceu Cardenal Herrera University

Moncada, Valencia, 46113, Spain

Location

Related Links

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Simple blind with evaluator blinded strategy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 28, 2019

Study Start

July 3, 2019

Primary Completion

July 3, 2019

Study Completion

December 18, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations