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Osteopathic Sympathetic Harmonization and Depression

Primary Purpose

Osteopathic Manipulative Treatment

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Osteopathic sympathic harmonization
Sham intervention
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopathic Manipulative Treatment focused on measuring Depression, Sympathetic nervous system, Cortisol

Eligibility Criteria

15 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sivas Cumhuriyet University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Osteopathy Group

Control Group

Arm Description

Stimulation on the sympathetic truncus and prevertebral ganglia

Stimulation on similar areas with lighter touch and shorter duration

Outcomes

Primary Outcome Measures

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.
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.
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.
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
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.
Demographic data
Sex; male or female
Demographic data
Age; years
Demographic data
Height (m); weight (kg); body mass index (kg/m2)

Secondary Outcome Measures

Full Information

First Posted
April 4, 2021
Last Updated
April 7, 2021
Sponsor
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT04840043
Brief Title
Osteopathic Sympathetic Harmonization and Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
March 23, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopathic Manipulative Treatment
Keywords
Depression, Sympathetic nervous system, Cortisol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A double-blind, placebo-controlled, randomized study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind trial
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathy Group
Arm Type
Experimental
Arm Description
Stimulation on the sympathetic truncus and prevertebral ganglia
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Stimulation on similar areas with lighter touch and shorter duration
Intervention Type
Other
Intervention Name(s)
Osteopathic sympathic harmonization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.
Primary Outcome Measure Information:
Title
The Beck Depression Inventory (BDI)
Description
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Time Frame
Before intervention
Title
The State-Trait Anxiety Inventory (STAI) Form - 1
Description
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.
Time Frame
Before intervention
Title
Change from Baseline The State-Trait Anxiety Inventory (STAI) Form - 2 at 20 minutes
Description
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.
Time Frame
Before intervention, immediately after the intervention, 20 minutes after the intervention
Title
Change from Baseline Heart rate and blood pressure measurements at 20 minutes
Description
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
Time Frame
Before intervention, immediately after the intervention, 20 minutes after the intervention
Title
Change from Baseline Salivary Biomarkers at 20 minutes
Description
Salivary a-amylase and cortisol levels were measured for each sample. These biomarkers were analysed Enzyme-Linked Immunosorbent Assay.
Time Frame
Before intervention, immediately after the intervention, 20 second after the intervention
Title
Demographic data
Description
Sex; male or female
Time Frame
Before intervention
Title
Demographic data
Description
Age; years
Time Frame
Before intervention
Title
Demographic data
Description
Height (m); weight (kg); body mass index (kg/m2)
Time Frame
Before intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Osman PALA, PhD
Organizational Affiliation
Cumhuriyet University, Faculty of Health Sciences, Physiotherapy and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seyit CITAKER, Prof
Organizational Affiliation
Gazi University, Faculty of Health Sciences, Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esra GUNEY, Assoc. Prof
Organizational Affiliation
Gazi University, Faculty of Medicine, Child and Adolescent Psychiatry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aylin SEPICI DINCEL, Prof
Organizational Affiliation
Gazi University, Faculty of Medicine, Medical Biochemistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Güner Melike GUVELI, MD
Organizational Affiliation
Gazi University, Faculty of Medicine, Child and Adolescent Psychiatry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Burak ARSLAN, MD
Organizational Affiliation
Gazi University, Faculty of Medicine, Medical Biochemistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sivas Cumhuriyet University
City
Si̇vas
ZIP/Postal Code
58140
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
January 1, 2022
Citations:
PubMed Identifier
20606239
Citation
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.
Results Reference
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Osteopathic Sympathetic Harmonization and Depression

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