Osteopathic Sympathetic Harmonization and Depression

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.

Study Overview

• Status: Completed
• Conditions: Osteopathic Manipulative Treatment
• Intervention / Treatment: Other: Osteopathic sympathic harmonization; Other: Sham intervention

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Si̇vas, Turkey, 58140
    • Sivas Cumhuriyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopathy Group; Stimulation on the sympathetic truncus and prevertebral ganglia	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 Comparator: Control Group; Stimulation on similar areas with lighter touch and shorter duration	Other: Sham intervention; Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Demographic data	Sex; male or female	Before intervention
Demographic data	Age; years	Before intervention
Demographic data	Height (m); weight (kg); body mass index (kg/m2)	Before intervention

Collaborators and Investigators

• Sponsor: Cumhuriyet University
• Investigators: Study Director: Omer Osman PALA, PhD, Cumhuriyet University, Faculty of Health Sciences, Physiotherapy and Rehabilitation; Principal Investigator: Seyit CITAKER, Prof, Gazi University, Faculty of Health Sciences, Physiotherapy and Rehabilitation; Principal Investigator: Esra GUNEY, Assoc. Prof, Gazi University, Faculty of Medicine, Child and Adolescent Psychiatry; Principal Investigator: Aylin SEPICI DINCEL, Prof, Gazi University, Faculty of Medicine, Medical Biochemistry; Principal Investigator: Güner Melike GUVELI, MD, Gazi University, Faculty of Medicine, Child and Adolescent Psychiatry; Principal Investigator: Burak ARSLAN, MD, Gazi University, Faculty of Medicine, Medical Biochemistry

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): March 23, 2018
• Study Completion (Actual): June 5, 2018

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Cortisol; Sympathetic nervous system
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: E-16-1106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: January 1, 2022
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No