Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT05187533
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2021-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sphenopalatine Ganglion Stimulation for Ocular and Oral Dryness
Sponsor:
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Organization:
Study Overview
Official Title:
Efficacy of the Sphenopalatine Ganglion Stimulation Osteopathic Protocol in Patients with Ocular and Oral Dryness
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dry Eye Disease (DED) is a multifactorial pathology characterized by inflammation of the lacrimal functional unit that develops in ocular surface pathology, severely affecting patients quality of life. The core of the treatment relies at present in antinflammatory topical therapies, which are still scarce.
The investigators hypothesize that osteopathy-based techniques may help these patients by influencing the central involvement regarding parasympathetic innervation of tear and saliva-secreting glands.
The aim of this osteopathic treatment protocol is to release the involved structures in the tear-secreting system innervation, such as the sphenopalatine ganglion. In addition, this ganglion innervates the minor salivary glands, therefore it is intended to help patients suffering from xerostomia.
The hypothesis then is that a systemic protocol treatment can help balance both parts of the vegetative nervous system (sympathetic and parasympathetic) with the objective of increasing the secretion of tear and saliva in patients with ocular and oral dryness (DED and xerostomia, respectively), thus improving their clinical situation.
This osteopathic protocol does not have the potential to cause adverse effects. The main objective is to analyze the efficacy of this protocol application in terms of improving symptoms and signs of ocular and oral dryness, tear film quality and inflammation molecule levels in tears and saliva.
The investigators hypothesize that osteopathy-based techniques may help these patients by influencing the central involvement regarding parasympathetic innervation of tear and saliva-secreting glands.
The aim of this osteopathic treatment protocol is to release the involved structures in the tear-secreting system innervation, such as the sphenopalatine ganglion. In addition, this ganglion innervates the minor salivary glands, therefore it is intended to help patients suffering from xerostomia.
The hypothesis then is that a systemic protocol treatment can help balance both parts of the vegetative nervous system (sympathetic and parasympathetic) with the objective of increasing the secretion of tear and saliva in patients with ocular and oral dryness (DED and xerostomia, respectively), thus improving their clinical situation.
This osteopathic protocol does not have the potential to cause adverse effects. The main objective is to analyze the efficacy of this protocol application in terms of improving symptoms and signs of ocular and oral dryness, tear film quality and inflammation molecule levels in tears and saliva.
Detailed Description:
This clinical study intended to offer an alternative therapeutic tool for a disease, dry eye, that is highly prevalent, causes a decreased in the quality of life and work productivity, and whose pharmacologic treatment is very limited.
The osteopathy protocol consists of an initial assessment of the cranial vault and 7 techniques through which the different structures involved are treated and are as follows: 1) balance of the cranio-sacral system; 2) reharmonization of sphenobasilar synchondrosis; 3) and 4) release of the bony components in the pterygo-palatine fossa (maxillas and sphenoid); 5) and 6) release of the bony components in relation with the main lacrimal gland (frontal and front-malar suture); and 7) sphenopalatine ganglion stimulation. The patient is always in supine position and the investigator is standing on the side.
The proposed osteopathy protocol is innocuous, with no possible adverse effects. The main objective is to analyze the efficacy of this protocol application in terms of improving symptoms and signs of ocular and oral dryness, tear film quality and inflammation molecule levels in tears and saliva.
Recruited patients will have dry eye disease (and subsequently ocular dryness) and oral dryness (xerostomia). Inclusion/exclusion criteria are detailed in the corresponding section below, as well as all outcome measures.
All COVID19-related sanitary regulations will be strictly followed.
The osteopathy protocol consists of an initial assessment of the cranial vault and 7 techniques through which the different structures involved are treated and are as follows: 1) balance of the cranio-sacral system; 2) reharmonization of sphenobasilar synchondrosis; 3) and 4) release of the bony components in the pterygo-palatine fossa (maxillas and sphenoid); 5) and 6) release of the bony components in relation with the main lacrimal gland (frontal and front-malar suture); and 7) sphenopalatine ganglion stimulation. The patient is always in supine position and the investigator is standing on the side.
The proposed osteopathy protocol is innocuous, with no possible adverse effects. The main objective is to analyze the efficacy of this protocol application in terms of improving symptoms and signs of ocular and oral dryness, tear film quality and inflammation molecule levels in tears and saliva.
Recruited patients will have dry eye disease (and subsequently ocular dryness) and oral dryness (xerostomia). Inclusion/exclusion criteria are detailed in the corresponding section below, as well as all outcome measures.
All COVID19-related sanitary regulations will be strictly followed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: