Osteopathic Manipulative TreatmentNCT04840043
Osteopathic Sympathetic Harmonization and Depression
A study testing Osteopathic sympathic harmonization in people with Osteopathic Manipulative Treatment, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Depression appears to be resistant to the available pharmacological treatments. Autonomic responses accompanied by any psychological stress are sympathetic nervous system (SNS) and neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (HPA) axis. Read more about this study
- Who is it for?
- Ages 15 to 21 years
- Conditions the study is for
- Osteopathic Manipulative Treatment
- What is being tested?
- Osteopathic sympathic harmonization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2017to 5 Jun 2018
- 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 15 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- To be diagnosed with clinical depression by a psychiatrist according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- Volunteering to participate in the study
Who cannot join
- Fever over 38.5
- Acute injury or infection
- Rib fracture
- Cardiac arrhythmia
- Using drugs that affect cortisol levels (oral contraceptives, hormonal drugs, antidepressants, antipsychotics etc.)
- Being pregnant, premenstrual or in the menstrual period for female participants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Effectiveness of the Osteopathic Sympathetic Harmonization Applications on the Sympathetic Nervous System and the HPA Axis With Depression Diagnosed Adolescents: A Double-blind, Placebo-controlled, Randomized Study
Depression appears to be resistant to the available pharmacological treatments. Autonomic responses accompanied by any psychological stress are sympathetic nervous system (SNS) and neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (HPA) axis. The purpose of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous system and HPA axis in adolescents with depression.
Read the detailed description
Depression diagnosed and volunteer to participate 39 cases who between the ages of 15-21 included. All participants were recruited and randomly assigned into two groups, the osteopathy group (OG) and the placebo group (PG). Stimulation on the sympathetic truncus and prevertebral ganglia were performed in the OG group. The stimulation of the PG group was performed with a lighter touch and a shorter duration in similar areas. Each participant was filled in the demographic data form, Beck Depression Scale and State and Trait Anxiety Inventory (STAI Form - 1 and Form - 2) before the application. Emotional state visual analog scale and STAI Form - 1 was filled and blood pressure and pulse measurement were made and saliva sample was taken before application, immediately after application and 20 minutes after application.
- Conditions
- Osteopathic Manipulative Treatment
- Being tested
- Osteopathic sympathic harmonization, Sham intervention
- Keywords
- Depression, Sympathetic nervous system, Cortisol
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic sympathic harmonizationOther
Treatments that harmonize at the sympathetic nerves or plexus, e.g., sympathetic trunk stimulation by means of the rib-raise technique or stimulation of the prevertebral ganglia.
Sham interventionOther
Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathy Group | Experimental | Stimulation on the sympathetic truncus and prevertebral ganglia Receives: Other: Osteopathic sympathic harmonization |
| Control Group | Sham comparator | Stimulation on similar areas with lighter touch and shorter duration Receives: Other: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Measured: Before intervention
The State-Trait Anxiety Inventory (STAI) Form - 1
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.
Measured: Before intervention
Change from Baseline The State-Trait Anxiety Inventory (STAI) Form - 2 at 20 minutes
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.
Measured: Before intervention, immediately after the intervention, 20 minutes after the intervention
Change from Baseline Heart rate and blood pressure measurements at 20 minutes
Heart rate (beats per minute) and blood pressure (mm/Hg) were measured with automatic blood pressure monitor (the Microlife BP 3BT0-A). It is a clinically validated and 1-star automatic blood pressure monitor
Measured: Before intervention, immediately after the intervention, 20 minutes after the intervention
Change from Baseline Salivary Biomarkers at 20 minutes
Salivary a-amylase and cortisol levels were measured for each sample. These biomarkers were analysed Enzyme-Linked Immunosorbent Assay.
Measured: Before intervention, immediately after the intervention, 20 second after the intervention
Demographic data
Sex; male or female
Measured: Before intervention
Demographic data
Age; years
Measured: Before intervention
Demographic data
Height (m); weight (kg); body mass index (kg/m2)
Measured: Before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start11 Oct 2017
- Primary completion23 Mar 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteopathic Manipulative TreatmentStudies 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
- A double-blind, placebo-controlled, randomized study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Osman PALA, Cumhuriyet University
- Investigators
- Omer Osman PALA, PhD, Study director, Cumhuriyet University, Faculty of Health Sciences, Physiotherapy and RehabilitationSeyit CITAKER, Prof, Principal investigator, Gazi University, Faculty of Health Sciences, Physiotherapy and RehabilitationEsra GUNEY, Assoc. Prof, Principal investigator, Gazi University, Faculty of Medicine, Child and Adolescent PsychiatryAylin SEPICI DINCEL, Prof, Principal investigator, Gazi University, Faculty of Medicine, Medical BiochemistryGüner Melike GUVELI, MD, Principal investigator, Gazi University, Faculty of Medicine, Child and Adolescent PsychiatryBurak ARSLAN, MD, Principal investigator, Gazi University, Faculty of Medicine, Medical Biochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840043
- Sponsor's protocol ID
- E-16-1106
- Status last verified
- Apr 2021
- First submitted
- 4 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.
PubMed 20606239Pala OO, Citaker S, Guney E, Sepici A, Guveli GM, Arslan B, Guru M. Effectiveness of osteopathic manipulative applications on hypothalamic-pituitary-adrenal (HPA) axis in youth with major depressive disorder: a randomized double-blind, placebo-controlled trial. J Osteopath Med. 2024 Feb 29;124(6):267-275. doi: 10.1515/jom-2023-0056. eCollection 2024 Jun 1.
PubMed 38414339
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Effectiveness of the Osteopathic Sympathetic Harmonization Applications on the Sympathetic Nervous System and the HPA Axis With Depression Diagnosed Adolescents: A Double-blind, Placebo-controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT04840043
- Acronym / sponsor ID
- E-16-1106
- Conditions
- Osteopathic Manipulative Treatment
- Keywords
- Depression, Sympathetic nervous system, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 9 Apr 2021 (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.
Depression appears to be resistant to the available pharmacological treatments. Autonomic responses accompanied by any psychological stress are sympathetic nervous system (SNS) and neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (HPA) axis. The purpose of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous system and HPA axis in adolescents with depression.
Detailed description
Depression diagnosed and volunteer to participate 39 cases who between the ages of 15-21 included. All participants were recruited and randomly assigned into two groups, the osteopathy group (OG) and the placebo group (PG). Stimulation on the sympathetic truncus and prevertebral ganglia were performed in the OG group. The stimulation of the PG group was performed with a lighter touch and a shorter duration in similar areas. Each participant was filled in the demographic data form, Beck Depression Scale and State and Trait Anxiety Inventory (STAI Form - 1 and Form - 2) before the application. Emotional state visual analog scale and STAI Form - 1 was filled and blood pressure and pulse measurement were made and saliva sample was taken before application, immediately after application and 20 minutes after application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, placebo-controlled, randomized study
| Arm | Type | Receives |
|---|---|---|
| Osteopathy Group | Experimental | Other: Osteopathic sympathic harmonizationStimulation on the sympathetic truncus and prevertebral ganglia |
| Control Group | Sham comparator | Other: Sham interventionStimulation on similar areas with lighter touch and shorter duration |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- To be diagnosed with clinical depression by a psychiatrist according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- Fever over 38.5
- Acute injury or infection
- Rib fracture
- Cardiac arrhythmia
- Using drugs that affect cortisol levels (oral contraceptives, hormonal drugs, antidepressants, antipsychotics etc.)
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 |
|---|---|---|
| Osteopathic sympathic harmonizationTreatments that harmonize at the sympathetic nerves or plexus, e.g., sympathetic trunk stimulation by means of the rib-raise technique or stimulation of the prevertebral ganglia. | Other | Osteopathy Group |
| Sham interventionDifferent location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia. | Other | Control Group |
Primary outcome
The Beck Depression Inventory (BDI)
Time frame: Before intervention
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
The State-Trait Anxiety Inventory (STAI) Form - 1
Time frame: Before intervention
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.
Change from Baseline The State-Trait Anxiety Inventory (STAI) Form - 2 at 20 minutes
Time frame: Before intervention, immediately after the intervention, 20 minutes after the intervention
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress.
Change from Baseline Heart rate and blood pressure measurements at 20 minutes
Time frame: Before intervention, immediately after the intervention, 20 minutes after the intervention
Heart rate (beats per minute) and blood pressure (mm/Hg) were measured with automatic blood pressure monitor (the Microlife BP 3BT0-A). It is a clinically validated and 1-star automatic blood pressure monitor
Change from Baseline Salivary Biomarkers at 20 minutes
Time frame: Before intervention, immediately after the intervention, 20 second after the intervention
Salivary a-amylase and cortisol levels were measured for each sample. These biomarkers were analysed Enzyme-Linked Immunosorbent Assay.
Demographic data
Time frame: Before intervention
Sex; male or female
Demographic data
Time frame: Before intervention
Age; years
Demographic data
Time frame: Before intervention
Height (m); weight (kg); body mass index (kg/m2)
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 9 Apr 2021.
- Background: PubMed 20606239Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.
- Derived from this study: PubMed 38414339Pala OO, Citaker S, Guney E, Sepici A, Guveli GM, Arslan B, Guru M. Effectiveness of osteopathic manipulative applications on hypothalamic-pituitary-adrenal (HPA) axis in youth with major depressive disorder: a randomized double-blind, placebo-controlled trial. J Osteopath Med. 2024 Feb 29;124(6):267-275. doi: 10.1515/jom-2023-0056. eCollection 2024 Jun 1.
- Individual participant dataSharing planned: Yes
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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.
Omer Osman PALA, PhD study director
Cumhuriyet University, Faculty of Health Sciences, Physiotherapy and Rehabilitation
Seyit CITAKER, Prof principal investigator
Gazi University, Faculty of Health Sciences, Physiotherapy and Rehabilitation
Esra GUNEY, Assoc. Prof principal investigator
Gazi University, Faculty of Medicine, Child and Adolescent Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic sympathic harmonization in people with Osteopathic Manipulative Treatment, run by Cumhuriyet 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 2 inclusion and 6 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 9 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
The Beck Depression Inventory (BDI) (time frame: Before intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840043, which also lists 2 linked publications.
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 9 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.