Effect of Craniosacral Osteopathic Treatment on Chronic Sinusitis: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sinonasal Outcome Test-22 (SNOT-22) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Control Group (Standard Medical Treatment)
Participants in this group will receive standard medical treatment for chronic rhinosinusitis according to current clinical guidelines.
干预措施: Standard Medical Treatment (Combination Product)
Control Group (Standard Medical Treatment)
Participants in this group will receive standard medical treatment for chronic rhinosinusitis according to current clinical guidelines.
干预措施: Craniosacral Osteopathic Manipulative Treatment (OM-KST) (Procedure)
Experimental Group (OM-KST + Medical Treatment)
Participants in this group will receive craniosacral osteopathic manipulative treatment (OM-KST) in addition to standard medical treatment.
干预措施: Standard Medical Treatment (Combination Product)
Experimental Group (OM-KST + Medical Treatment)
Participants in this group will receive craniosacral osteopathic manipulative treatment (OM-KST) in addition to standard medical treatment.
干预措施: Craniosacral Osteopathic Manipulative Treatment (OM-KST) (Procedure)
结局指标
主要结局
Sinonasal Outcome Test-22 (SNOT-22) score
时间窗: 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)
时间窗: Baseline to 4 weeks (post-intervention)
Pain threshold will be measured using a digital algometer over sinus regions.
次要结局
- 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)
研究者
Ayça Araci
Asistant Proffesor
Alanya Alaaddin Keykubat University
