NCT05187533|Completed
Sphenopalatine Ganglion Stimulation for Ocular and Oral Dryness
Efficacy of the Sphenopalatine Ganglion Stimulation Osteopathic Protocol in Patients with Ocular and Oral Dryness
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Efficacy of the Sphenopalatine Ganglion Stimulation Osteopathic Protocol in Patients with Ocular and Oral Dryness
Sponsor study identifier
interventional
30
1 country
1
Study Start
January 15, 2022
Actual (reported)Primary Completion
October 30, 2024
Actual (reported)Study Completion
October 30, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2021
Actual (reported)January 12, 2022
Actual (reported)January 15, 2022
Actual (reported)October 30, 2024
Actual (reported)October 30, 2024
Actual (reported)Ocular Surface Disease Index (OSDI)
Score value 0-48, where higher score means a worse outcome.
6 Weeks
Ocular Surface Disease Index (OSDI)
Score value 0-48, where higher score means a worse outcome.
18 Weeks
Modified Single-Item Score Dry Eye-Questionnaire (mSIDEQ)
Score value 0-28, where higher score means a worse outcome
6 Weeks
Osteopathic protocol of sphenopalatine ganglion stimulation
Osteopathic protocol of sphenopalatine ganglion stimulation
Osteopathic protocol of sphenopalatine ganglion stimulation
Sphenopalatine Ganglion Stimulation to improve lacrimal and salivary gland secretion to improve ocular and oral dryness
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
IOBA
Valladolid, Valladolid, 47011, Spain
30 participants (actual enrollment reported by the registry).
First Submitted
October 28, 2021
First Posted
January 12, 2022
Study Start
January 15, 2022
Actual (reported)Modified Single-Item Score Dry Eye-Questionnaire (mSIDEQ)
Score value 0-28, where higher score means a worse outcome
18 Weeks
Visual analogue Scale (VAS)
Unique measurements 0-10, where higher score means a worse outcome
6 Weeks
Visual analogue Scale (VAS)
Unique measurements 0-10, where higher score means a worse outcome
18 Weeks
Change in Dry Eye Symptoms Questionnaire (CDES-Q)
First question compares how the patient is at the moment compared with last session in terms of "Equal", "Better" or "Worse". If better or worse is chose, two more questions measure how much improvement or worsening from a 0-10 scale, where higher score means a worse outcome.
6 Weeks
Change in Dry Eye Symptoms Questionnaire (CDES-Q)
First question compares how the patient is at the moment compared with last session in terms of "Equal", "Better" or "Worse". If better or worse is chose, two more questions measure how much improvement or worsening from a 0-10 scale, where higher score means a worse outcome.
18 Weeks
Statistically significant amelioration in oral symptoms
Enhancement in Xerostomia Inventory Spanish version (XI-Sp) test score 0-11, where higher score means a worse outcome.
6 Weeks
Statistically significant amelioration in oral symptoms
Enhancement in Xerostomia Inventory Spanish version (XI-Sp) test score 0-11, where higher score means a worse outcome.
18 Weeks
Statistically significant improvement in tear secretion
Schirmer I test, which test score is 0-35 mm, where lower score means a worse outcome.
6 Weeks
Statistically significant improvement in tear secretion
Schirmer I test, which test score is 0-35 mm, where lower score means a worse outcome.
18 Weeks
Statistically significant improvement in salivary discharge
Salivary flow rate, where flow rate below 0,1ml flow is considered hyposalivation.
6 Weeks
Statistically significant improvement in salivary discharge
Salivary flow rate, where flow rate below 0,1ml flow is considered hyposalivation.
18 Weeks
Decrease in tear collection time
18 Weeks
Increased salivary flow rate
18 Weeks
Lipiflow interferometry - lipid layer thickness
18 Weeks
Lipiflow interferometry - incomplete blink rate
18 Weeks
Lipiflow interferometry - c-factor
18 Weeks
Contact the study team to confirm eligibility.
Primary Completion
October 30, 2024
Actual (reported)Study Completion
October 30, 2024
Actual (reported)Last Updated
November 1, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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