---
title: Craniosacral Osteopathic Treatment for Chronic Sinusitis
nct_id: NCT07542444
overall_status: COMPLETED
phase: NA
sponsor: Alanya Alaaddin Keykubat University
study_type: INTERVENTIONAL
primary_condition: Craniosacral Osteopathic Manipulation
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07542444.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07542444"
ct_last_update_post_date: 2026-04-21
last_seen_at: "2026-05-12T07:22:32.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Craniosacral Osteopathic Treatment for Chronic Sinusitis

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

**NCT ID:** [NCT07542444](https://clinicaltrials.gov/study/NCT07542444)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Alanya Alaaddin Keykubat University
- **Conditions:** Craniosacral Osteopathic Manipulation, Chronic Sinusitis, Physiotherapy and Rehabilitation, Ear,Nose and Throat Surgery
- **Start Date:** 2024-11-15
- **Completion Date:** 2026-02-25
- **CT.gov Last Update:** 2026-04-21

## 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.

## Detailed Description

Chronic rhinosinusitis (CRS) is a persistent inflammatory condition of the sinonasal mucosa lasting longer than 12 weeks and affecting approximately 10% of the global population. It is characterized by symptoms such as nasal obstruction, mucopurulent discharge, facial pain/pressure, and olfactory dysfunction, all of which significantly impair quality of life. Despite standard medical management-including intranasal corticosteroids, saline irrigation, antihistamines, and antibiotics when indicated-a substantial proportion of patients experience persistent or recurrent symptoms, highlighting the need for complementary and integrative therapeutic approaches.

Osteopathic manipulative treatment (OMT), particularly craniosacral techniques, has been proposed as a therapeutic approach that may influence physiological processes relevant to CRS. These mechanisms include modulation of the autonomic nervous system, enhancement of lymphatic and venous drainage, and improvement of cranial rhythmic impulse and tissue mobility. Through these mechanisms, OMT may facilitate mucociliary clearance and contribute to the reduction of inflammation and symptom burden.

Although preliminary studies have reported beneficial effects of osteopathic and manual therapy interventions in CRS, existing evidence is limited by small sample sizes, lack of adequate control groups, and reliance predominantly on subjective outcome measures. Furthermore, objective assessments such as endoscopic findings and imaging-based evaluations have been insufficiently integrated into prior research.

The present study is designed as a prospective, two-arm, randomized controlled trial to evaluate the effectiveness of craniosacral osteopathic manipulative treatment (OM-KST) as an adjunct to standard medical therapy in individuals with CRS. Eligible participants aged 18-65 years diagnosed with CRS by an otorhinolaryngologist will be randomly assigned to either a control group receiving standard medical treatment or an intervention group receiving OM-KST in addition to medical treatment.

The intervention protocol will consist of eight sessions over a 4-week period (two sessions per week), with each session lasting approximately 45 minutes. The OM-KST protocol will include a structured sequence of techniques focusing on vagal stimulation, lymphatic drainage, and craniosacral regulation.

Outcome measures will be assessed at baseline (T0), immediately after the intervention (T1), and at follow-up. Both subjective and objective measures will be employed, including validated questionnaires such as the Sinonasal Outcome Test (SNOT-22), Nasal Obstruction Symptom Evaluation (NOSE), and EuroQol-5D, as well as pressure pain threshold assessment using algometry and sinonasal endoscopic evaluation. Where appropriate, imaging-based assessments may be incorporated to evaluate structural and inflammatory changes.

Statistical analyses will be conducted using appropriate parametric or non-parametric tests depending on data distribution, with a significance level set at p \< 0.05. Effect sizes and clinically meaningful changes will also be considered to enhance the interpretation of clinical relevance.

This study aims to provide high-quality evidence regarding the clinical effectiveness of a multimodal and integrative treatment strategy for CRS by combining standardized medical therapy with osteopathic craniosacral interventions. The findings are expected to contribute to the development of evidence-based, patient-centered management approaches and to address existing gaps in the literature by integrating both objective and patient-reported outcomes.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
```

## Arms

- **Control Group (Standard Medical Treatment)** (ACTIVE_COMPARATOR) — Participants in this group will receive standard medical treatment for chronic rhinosinusitis according to current clinical guidelines.
- **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.

## 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.
- **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.

## Primary Outcomes

- **Sinonasal Outcome Test-22 (SNOT-22) score** _(time frame: Baseline to 4 weeks (post-intervention))_ — 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.
- **Pressure pain threshold (algometry)** _(time frame: Baseline to 4 weeks (post-intervention))_ — Pain threshold will be measured using a digital algometer over sinus regions.

## Secondary Outcomes

- **Nasal Obstruction Symptom Evaluation (NOSE) score** _(time frame: Baseline to 4 weeks)_
- **sinonasal endoscopic findings (Lund-Kennedy score)** _(time frame: Baseline to 4 weeks)_
- **Health-related quality of life (EuroQol-5D)** _(time frame: Baseline to 4 weeks)_

## Locations (1)

- Alanya Alaaddin Keykubat University, Alanya, Antalya, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.alanya alaaddin keykubat university|alanya|antalya|turkey (türkiye)` — added _(2026-05-12)_

---

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