NCT05583760

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

October 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

Same day

First QC Date

October 10, 2022

Last Update Submit

February 7, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • stabilometric measurements: oscillation about the X-axis

    (mm)

    five minutes post-intervention

  • stabilometric measurements: oscillation about the Y-axis

    (mm)

    five minutes post-intervention

  • stabilometric measurements: area of the ellipse

    (cm2)

    five minutes post-intervention

  • static baropodometric measurements: scan Foot bearing area

    (cm2)

    five minutes post-intervention

  • static baropodometric measurements: scan percentage of body load supported by each foot

    five minutes post-intervention

  • static baropodometric measurements: scan point of maximum plantar pressure

    (kg/cm2)

    five minutes post-intervention

Study Arms (2)

Experimental: Osteopathic manipulation TUG for scaphoid bone

EXPERIMENTAL
Procedure: Experimental: Osteopathic manipulation TUG for scaphoid bone

Sham group: Sham osteopathic manipulation TUG for scaphoid bone

SHAM COMPARATOR
Procedure: Sham group: Sham osteopathic manipulation TUG for scaphoid bone

Interventions

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.

Experimental: 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.

Sham group: Sham osteopathic manipulation TUG for scaphoid bone

Eligibility Criteria

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

You may qualify if:

  • Subjects with right scaphoid external rotation dysfunction

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sergio Montero Navarro

Elche, Alicante, 03204, Spain

Location

Related Publications (5)

  • Latash ML, Krishnamoorthy V, Scholz JP, Zatsiorsky VM. Postural synergies and their development. Neural Plast. 2005;12(2-3):119-30; discussion 263-72. doi: 10.1155/NP.2005.119.

    PMID: 16097480BACKGROUND
  • Zhang Y, Kiemel T, Jeka J. The influence of sensory information on two-component coordination during quiet stance. Gait Posture. 2007 Jul;26(2):263-71. doi: 10.1016/j.gaitpost.2006.09.007. Epub 2006 Oct 13.

    PMID: 17046262BACKGROUND
  • Myklebust JB, Prieto T, Myklebust B. Evaluation of nonlinear dynamics in postural steadiness time series. Ann Biomed Eng. 1995 Nov-Dec;23(6):711-9. doi: 10.1007/BF02584470.

    PMID: 8572421BACKGROUND
  • Hessert MJ, Vyas M, Leach J, Hu K, Lipsitz LA, Novak V. Foot pressure distribution during walking in young and old adults. BMC Geriatr. 2005 May 19;5:8. doi: 10.1186/1471-2318-5-8.

    PMID: 15943881BACKGROUND
  • Van Buskirk RL. Nociceptive reflexes and the somatic dysfunction: a model. J Am Osteopath Assoc. 1990 Sep;90(9):792-4, 797-809.

    PMID: 2211195BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
SINGLE BLIND (PARTICIPANT)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 18, 2022

Study Start

October 18, 2022

Primary Completion

October 18, 2022

Study Completion

February 7, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations