NCT04863209

Brief Summary

The purpose of this study is to assess the effects osteopathic techniques at the upper cervical vertebrae or at the sphenopalatine ganglia on the intraocular pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

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

April 20, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 28, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2021

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

April 20, 2021

Last Update Submit

November 21, 2021

Conditions

Keywords

intraocular pressuresphenopalatine ganglionsuperior cervical ganglionaqueous humour

Outcome Measures

Primary Outcomes (2)

  • Change of the intraocular pressure after upper cervical manipulation

    After this manipulation, it is expected that there will be a sympathetic response increasing the intraocular pressure.

    Immediately after the intervention and 30 minutes after the intervention

  • Change of the intraocular pressure after sphenopalatine ganglion manipulation

    After this manipulation, it is expected that there will be a parasympathetic response decreasing the intraocular pressure.

    Immediately after the intervention and 30 minutes after the intervention

Study Arms (3)

Upper cervical manipulation group

EXPERIMENTAL

The patient will be in the supine position. The cephalic hand will make contact with one side of the patient's skull, leaving the sternocleidomastoid muscle between the third and fourth fingers. The caudal hand will make global contact with the patient's skull on the opposite side. The therapist should place his torso on the patient's head, leaving the two forearms aligned with the axis of the patient's spine, as this technique is applied to the axis of the odontoid process of the ax. With neutral flexion-extension the therapist will place the rotation parameter to the opposite side (70-80 degrees) and a small contralateral inclination. Then it will search for the driving barrier with a small axial traction movement. When the driving barrier is found, the thrust should be applied in a helical direction, increasing rotation and traction. It will be applied bilaterally.

Other: Upper cervical manipulation

Sphenopalatine ganglion group

EXPERIMENTAL

The patient will be supine on the bench and the therapist with gloves will sit next to the patient contralateral to the manipulated sphenopalatine ganglion (SPG). One of the therapist's hands will be placed flat in contact with the apex of the patient's head to stabilize it. The patient will be instructed to open his mouth and deviate the mandible laterally to the same side of the ganglion to be treated. The therapist will then apply pressure to the SPG with the fifth finger of your other hand in the patient's mouth, moving up along the alveolar process of the maxilla teeth to reach the pterygoid process. The therapist will keep the patient's head elevated until the lateral pterygoid muscle relaxes. Then, the pressure will be applied into the pterygopalatine fossa. The therapist will then apply gentle pressure on the SPG with the pulp of the fifth finger until tissue relaxation. He will then release the contralateral SPG in the same way.

Other: Sphenopalatine ganglion manipulation

Control Group

NO INTERVENTION

The patient will lie down on the bench for 10 minutes.

Interventions

The patient will receive an upper cervical manipulation as described in the Experimental Group 1.

Upper cervical manipulation group

The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.

Sphenopalatine ganglion group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Intraocular pressure below 21mmHg

You may not qualify if:

  • Positive Klein test
  • Use of medications that affect the circulatory system in up to one month before the procedures;
  • Caffeine use 24 hours before procedures;
  • Presence of ophthalmic diseases;
  • History of hypertension or diabetes;
  • Blindness;
  • Tumor in the head;
  • Skull or cervical fractures that occurred less than 6 months ago.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Educação Física

Jundiaí, São Paulo, 13208-120, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DO

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 28, 2021

Study Start

September 28, 2021

Primary Completion

November 9, 2021

Study Completion

November 19, 2021

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations