Osteopathic Sympathetic Harmonization and Depression

Osteopathic Manipulative Treatment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04840043
• Other study ID #: E-16-1106
• Status: Completed
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: June 5, 2018

Study information

• Verified date: April 2021
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The purpose of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous system and HPA axis in adolescents with depression.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 5, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Osteopathic Manipulative Treatment

Intervention

Other:
• Osteopathic sympathic harmonization
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 intervention
Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.

Locations

Country	Name	City	State
Turkey	Sivas Cumhuriyet University	Si?vas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before intervention
Primary	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.	Before intervention
Primary	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.	Before intervention, immediately after the intervention, 20 minutes after the intervention
Primary	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	Before intervention, immediately after the intervention, 20 minutes after the intervention
Primary	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.	Before intervention, immediately after the intervention, 20 second after the intervention
Primary	Demographic data	Sex; male or female	Before intervention
Primary	Demographic data	Age; years	Before intervention
Primary	Demographic data	Height (m); weight (kg); body mass index (kg/m2)	Before intervention