Intraocular PressureNCT04863209
Effect of Osteopathic Techiniques on Intraocular Pressure
A study testing Upper cervical manipulation and Sphenopalatine ganglion manipulation in people with Intraocular Pressure and Osteopathic Manipulative Treatment, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure, Osteopathic Manipulative Treatment
- What is being tested?
- Upper cervical manipulation and Sphenopalatine ganglion manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Sep 2021to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Intraocular pressure below 21mmHg
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Osteopathic Techiniques on Intraocular Pressure: a Randomized Double-blind Clinical Trial
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.
Read the detailed description
The 7 volunteers will be randomized into 3 groups and there will be an experimental group 1 that will receive a technique of manipulation of the upper cervical, an experimental group 2 that will receive a technique of manipulation of the sphenopalatine ganglion and a control group that will not receive any intervention. Each volunteer will participate in the 3 groups. There will be 4 assessments, one before the procedure and one just after each procedure, including the control.
- Being tested
- Upper cervical manipulation, Sphenopalatine ganglion manipulation
- Keywords
- intraocular pressure, sphenopalatine ganglion, superior cervical ganglion, aqueous humour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper cervical manipulationOther
The patient will receive an upper cervical manipulation as described in the Experimental Group 1.
Sphenopalatine ganglion manipulationOther
The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sphenopalatine ganglion manipulation |
| Control Group | No intervention | The patient will lie down on the bench for 10 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the intervention and 30 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start28 Sep 2021
- Primary completion9 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodolfo Amoroso Borges, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863209
- Sponsor's protocol ID
- RBorges
- Status last verified
- Nov 2021
- First submitted
- 20 Apr 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Techiniques on Intraocular Pressure: a Randomized Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04863209
- Acronym / sponsor ID
- RBorges
- Keywords
- intraocular pressure, sphenopalatine ganglion, superior cervical ganglion, aqueous humour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The 7 volunteers will be randomized into 3 groups and there will be an experimental group 1 that will receive a technique of manipulation of the upper cervical, an experimental group 2 that will receive a technique of manipulation of the sphenopalatine ganglion and a control group that will not receive any intervention. Each volunteer will participate in the 3 groups. There will be 4 assessments, one before the procedure and one just after each procedure, including the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Upper cervical manipulation group | Experimental | Other: Upper cervical manipulationThe 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. |
| Sphenopalatine ganglion group | Experimental | Other: Sphenopalatine ganglion manipulationThe 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. |
| Control Group | No intervention | –The patient will lie down on the bench for 10 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Intraocular pressure below 21mmHg
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper cervical manipulationThe patient will receive an upper cervical manipulation as described in the Experimental Group 1. | Other | Upper cervical manipulation group |
| Sphenopalatine ganglion manipulationThe patient will receive a sphenopalatine ganglion as described in the Experimental Group 2. | Other | Sphenopalatine ganglion group |
Primary outcome
Change of the intraocular pressure after upper cervical manipulation
Time frame: Immediately after the intervention and 30 minutes after the intervention
After this manipulation, it is expected that there will be a sympathetic response increasing the intraocular pressure.
Change of the intraocular pressure after sphenopalatine ganglion manipulation
Time frame: Immediately after the intervention and 30 minutes after the intervention
After this manipulation, it is expected that there will be a parasympathetic response decreasing the intraocular pressure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper cervical manipulation and Sphenopalatine ganglion manipulation in people with Intraocular Pressure and Osteopathic Manipulative Treatment, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the intraocular pressure after upper cervical manipulation (time frame: Immediately after the intervention and 30 minutes after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.