Craniosacral Osteopathic Treatment for Chronic Sinusitis

NCT07542444 | Completed

• 1 other identifier: 14.04.2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Craniosacral Osteopathic Manipulation; Chronic Sinusitis; Physiotherapy and Rehabilitation; Ear,Nose and Throat Surgery

Keywords

Craniosacral Osteopathic Manipulative treatment; Chronic Sinusitis; Physiotherapy and Rehabilitation; Ear.Nose and Throat Surgery

Outcome Measures

Primary Outcomes (2)

• Sinonasal Outcome Test-22 (SNOT-22) score

  The SNOT-22 is a validated patient-reported outcome measure assessing symptom severity and quality of life in chronic rhinosinusitis. Scores range from 0 to 110, with higher scores indicating worse symptoms.

  Baseline to 4 weeks (post-intervention)

• Pressure pain threshold (algometry)

  Pain threshold will be measured using a digital algometer over sinus regions.

  Baseline to 4 weeks (post-intervention)

Secondary Outcomes (3)

• Nasal Obstruction Symptom Evaluation (NOSE) score

  Baseline to 4 weeks

• sinonasal endoscopic findings (Lund-Kennedy score)

  Baseline to 4 weeks

• Health-related quality of life (EuroQol-5D)

  Baseline to 4 weeks

Study Arms (2)

Control Group (Standard Medical Treatment)

ACTIVE COMPARATOR

Participants in this group will receive standard medical treatment for chronic rhinosinusitis according to current clinical guidelines.

Combination Product: Standard Medical Treatment; Procedure: Craniosacral Osteopathic Manipulative Treatment (OM-KST)

Experimental Group (OM-KST + Medical Treatment)

EXPERIMENTAL

Participants in this group will receive craniosacral osteopathic manipulative treatment (OM-KST) in addition to standard medical treatment.

Combination Product: Standard Medical Treatment; Procedure: Craniosacral Osteopathic Manipulative Treatment (OM-KST)

Interventions

Standard Medical Treatment COMBINATION_PRODUCT

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.

Control Group (Standard Medical Treatment); Experimental Group (OM-KST + Medical Treatment)

Craniosacral Osteopathic Manipulative Treatment (OM-KST) PROCEDURE

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.

Control Group (Standard Medical Treatment); Experimental Group (OM-KST + Medical Treatment)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• Diagnosis of chronic rhinosinusitis (CRS) confirmed by an otorhinolaryngologist
• Presence of at least two of the following symptoms for ≥12 weeks:
• Nasal obstruction
• Mucopurulent nasal discharge
• Facial pain/pressure
• Reduced or loss of smell
• Ability to provide informed consent

You may not qualify if:

• Acute rhinosinusitis or acute exacerbation of CRS
• History of cranial, facial, or cervical surgery within the past year
• Neurological or structural conditions contraindicating craniosacral therapy (e.g., intracranial hemorrhage, aneurysm, Chiari malformation)
• Cerebrospinal fluid (CSF) leak
• Recent manual therapy intervention (within the last 2 months)
• Use of additional therapeutic interventions during the study period
• Severe cognitive impairment limiting participation or informed consent
• Pregnancy (high-risk pregnancy)

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead

Study Sites (1)

Alanya Alaaddin Keykubat University

Alanya, Antalya, 07400, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is designed as an open-label randomized controlled trial. Due to the nature of the intervention, participant blinding is not feasible, as individuals receiving craniosacral osteopathic manipulative treatment (OM-KST) can clearly distinguish the manual therapy intervention from standard medical treatment. No sham or placebo intervention is applied. Outcome assessments are conducted using standardized and validated measurement tools to minimize potential assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Proffesor

Model Details: This study aims to evaluate the effectiveness of craniosacral osteopathic manipulative treatment (OM-KST) as an adjunct to standard medical therapy in patients with chronic rhinosinusitis (CRS). In this prospective randomized controlled trial, participants will be allocated to either a control group receiving standard medical treatment or an intervention group receiving OM-KST in addition to medical treatment. The intervention will consist of eight sessions over four weeks. Outcomes, including symptom severity, nasal obstruction, quality of life, and objective clinical findings, will be assessed at baseline, post-intervention, and follow-up.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start: November 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: February 25, 2026
• Last Updated: April 21, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)