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COMPLETED
NCT07542444
NA

Craniosacral Osteopathic Treatment for Chronic Sinusitis

Sponsor: Alanya Alaaddin Keykubat University

View on ClinicalTrials.gov

Summary

Chronic rhinosinusitis (CRS) is a common inflammatory condition that significantly impairs quality of life and is often insufficiently managed with standard medical therapy alone. Emerging evidence suggests that manual therapy approaches, including osteopathic manipulative treatment, may provide additional clinical benefits by improving lymphatic drainage, modulating autonomic function, and enhancing mucociliary clearance. This randomized controlled trial aims to investigate the effectiveness of craniosacral osteopathic manipulative treatment (OM-KST) as an adjunct to standard medical therapy in individuals with chronic rhinosinusitis. Participants diagnosed with CRS will be randomly allocated into two groups: a control group receiving standard medical treatment and an intervention group receiving OM-KST in addition to medical treatment. The intervention will consist of an 8-session craniosacral osteopathic protocol applied over 4 weeks. Outcomes will be assessed at baseline, post-intervention, and follow-up periods using validated clinical and patient-reported measures. Primary and secondary outcomes will include symptom severity, nasal obstruction, pain threshold, endoscopic findings, and quality of life (e.g., SNOT-22, NOSE, EuroQol-5D). This study is designed to provide high-level evidence on the clinical effectiveness of a multidisciplinary and integrative treatment approach for CRS, addressing both subjective symptoms and objective clinical findings.

Official title: Effect of Craniosacral Osteopathic Treatment on Chronic Sinusitis: A Randomized Controlled Trial"

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-11-15

Completion Date

2026-02-25

Last Updated

2026-04-21

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Standard Medical Treatment

Standard medical treatment will include intranasal corticosteroids, saline nasal irrigation, antihistamines, and antibiotics when indicated, as prescribed by an otorhinolaryngologist according to current clinical guidelines.

PROCEDURE

Craniosacral Osteopathic Manipulative Treatment (OM-KST)

OM-KST will be applied for 8 sessions over 4 weeks (2 sessions per week), with each session lasting approximately 45 minutes. The intervention will follow a structured protocol including vagal stimulation, lymphatic drainage, and craniosacral techniques.

Locations (1)

Alanya Alaaddin Keykubat University

Alanya, Antalya, Turkey (Türkiye)