Stabilometric and Baropodometric Evaluation After Osteopathic Scaphoid Tug Manipulation

February 7, 2023 updated by: SERGIO MONTERO NAVARRO, Cardenal Herrera University

Stabilometric and Baropodometric Evaluation of Osteopathic Scaphoid Tug Manipulation

This is a clinical, longitudinal, prospective and randomised study in which the subject will be assessed by stabilometric and baropodometric techniques on two occasions (before being subjected to the scaphoid tug manipulation for the experimental group or placebo technique in the case of the control group).

Study Overview

Study Type

Interventional

Enrollment (Actual)

36

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

    • Alicante
      • Elche, Alicante, Spain, 03204
        • Sergio Montero Navarro

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with right scaphoid external rotation dysfunction

Exclusion Criteria:

  • Suffering from disorders that alter balance (tension headaches, vertigo, migraines...).
  • Deformities, orthopaedic injuries or sequelae in the limbs or spine that may alter postural statics (valgus-varus, lower limb operations, lower limb dysmetries, scoliosis, etc.).
  • Pathologies or sequelae related to the postural sensors or disorders in the same:

    • Uncorrected visual defects.
    • Vestibular disorders.
    • Uncorrected stomatological disorders.
    • Sensory alterations in the foot sensor (Hypoaesthesia, Morton's neuroma, tarsal canal syndrome, etc.).
    • Cutaneous alterations that influence the foot pick-up (papillomas, plantar warts, ingrown toenails, etc.).
    • Ingestion of medication that alters the perception of stability.
  • Having any contraindication to the scaphoid tug technique.
  • Having carried out intense physical activity immediately prior to the study.
  • Having received osteopathic treatment in the last month.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental: Osteopathic manipulation TUG for scaphoid bone
The sequence of execution of the scaphoid TUG technique shall be applied as follows. Patient in the supine position. The inner hand of the intervener makes contact with the pisiform through the hypothenar eminence and ulnar border of the hand over the scaphoid tubercle, the outer hand reinforces the contact. The thumbs are directed to the sole of the patient's foot. The parameters are sought by bringing the sole of the foot into eversion, thus bringing the scaphoid into internal rotation (the direction of correction). In order to reduce the slack, the operator drops his body weight backwards while increasing the internal rotation parameter of the scaphoid. The manipulation is performed by associating a rapid traction movement with an increase of the correction parameter towards the internal rotation of the scaphoid.
SHAM_COMPARATOR: Sham group: Sham osteopathic manipulation TUG for scaphoid bone
The intervention will be performed in the same way as the intervention group, without actually performing the TUG manipulation on the scaphoid bone, only placing it in tension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stabilometric measurements: oscillation about the X-axis
Time Frame: five minutes post-intervention
(mm)
five minutes post-intervention
stabilometric measurements: oscillation about the Y-axis
Time Frame: five minutes post-intervention
(mm)
five minutes post-intervention
stabilometric measurements: area of the ellipse
Time Frame: five minutes post-intervention
(cm2)
five minutes post-intervention
static baropodometric measurements: scan Foot bearing area
Time Frame: five minutes post-intervention
(cm2)
five minutes post-intervention
static baropodometric measurements: scan percentage of body load supported by each foot
Time Frame: five minutes post-intervention
five minutes post-intervention
static baropodometric measurements: scan point of maximum plantar pressure
Time Frame: five minutes post-intervention
(kg/cm2)
five minutes post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

October 18, 2022

Primary Completion (ACTUAL)

October 18, 2022

Study Completion (ACTUAL)

February 7, 2023

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (ACTUAL)

October 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CEEI22/322

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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