Craniosacral Osteopathic ManipulationNCT07542444
Craniosacral Osteopathic Treatment for Chronic Sinusitis
A study testing Standard Medical Treatment and Craniosacral Osteopathic Manipulative Treatment (OM-KST) in people with Craniosacral Osteopathic Manipulation and Chronic Sinusitis, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Craniosacral Osteopathic Manipulation, Chronic Sinusitis, Physiotherapy and Rehabilitation
- What is being tested?
- Standard Medical Treatment and Craniosacral Osteopathic Manipulative Treatment (OM-KST)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University
Alanya, Antalya, 07400
About this study
Official title: Effect of Craniosacral Osteopathic Treatment on Chronic Sinusitis: A Randomized Controlled Trial"
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.
Read more
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.
Read the 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.
- Conditions
- Craniosacral Osteopathic Manipulation, Chronic Sinusitis, Physiotherapy and Rehabilitation, Ear,Nose and Throat Surgery
- Being tested
- Standard Medical Treatment, Craniosacral Osteopathic Manipulative Treatment (OM-KST)
- Keywords
- Craniosacral Osteopathic Manipulative treatment, Chronic Sinusitis, Physiotherapy and Rehabilitation, Ear.Nose and Throat Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical TreatmentCombination 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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Standard Medical Treatment) | Active comparator | Participants in this group will receive standard medical treatment for chronic rhinosinusitis according to current clinical guidelines. Receives: 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. Receives: Combination Product: Standard Medical Treatment; Procedure: Craniosacral Osteopathic Manipulative Treatment (OM-KST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 weeks (post-intervention)
Pressure pain threshold (algometry)
Pain threshold will be measured using a digital algometer over sinus regions.
Measured: Baseline to 4 weeks (post-intervention)
Secondary outcomes (3)
Nasal Obstruction Symptom Evaluation (NOSE) score
A validated scale assessing nasal obstruction severity (0-100).
Measured: Baseline to 4 weeks
sinonasal endoscopic findings (Lund-Kennedy score)
Endoscopic findings will be scored using the Lund-Kennedy system.
Measured: Baseline to 4 weeks
Health-related quality of life (EuroQol-5D)
Health-related quality of life will be assessed using EQ-5D.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Nov 2024
- Primary completion15 Dec 2024
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniosacral Osteopathic ManipulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542444
- Sponsor's protocol ID
- 14.04.2026
- Status last verified
- Oct 2024
- First submitted
- 15 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical and legal restrictions related to the protection of personal data. The study involves sensitive health information, and sharing de-identified data may still pose a risk of re-identification. All data will be securely stored and used only for the purposes of this study in accordance with institutional and national data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Craniosacral Osteopathic Treatment on Chronic Sinusitis: A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07542444
- Acronym / sponsor ID
- 14.04.2026
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group (Standard Medical Treatment) | Active comparator | Combination Product: Standard Medical Treatment, Procedure: Craniosacral Osteopathic Manipulative Treatment (OM-KST)Participants in this group will receive standard medical treatment for chronic rhinosinusitis according to current clinical guidelines. |
| Experimental Group (OM-KST + Medical Treatment) | Experimental | Combination Product: Standard Medical Treatment, Procedure: Craniosacral Osteopathic Manipulative Treatment (OM-KST)Participants in this group will receive craniosacral osteopathic manipulative treatment (OM-KST) in addition to standard medical treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Medical TreatmentStandard medical treatment will include intranasal corticosteroids, saline nasal irrigation, antihistamines, and antibiotics when indicated, as prescribed by an otorhinolaryngologist according to current clinical guidelines. | Combination product | Control Group (Standard Medical Treatment), Experimental Group (OM-KST + Medical Treatment) |
| 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. | Procedure or surgery | Control Group (Standard Medical Treatment), Experimental Group (OM-KST + Medical Treatment) |
Primary outcome
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.
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical and legal restrictions related to the protection of personal data. The study involves sensitive health information, and sharing de-identified data may still pose a risk of re-identification. All data will be securely stored and used only for the purposes of this study in accordance with institutional and national data protection regulations.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Medical Treatment and Craniosacral Osteopathic Manipulative Treatment (OM-KST) in people with Craniosacral Osteopathic Manipulation and Chronic Sinusitis, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinonasal Outcome Test-22 (SNOT-22) score (time frame: Baseline to 4 weeks (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.