Osteopathic Sympathetic Harmonization and Depression

NCT04840043 | Completed

• 1 other identifier: E-16-1106
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopathic Manipulative Treatment

Keywords

Depression; Sympathetic nervous system; Cortisol

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Osteopathy Group

EXPERIMENTAL

Stimulation on the sympathetic truncus and prevertebral ganglia

Other: Osteopathic sympathic harmonization

Control Group

SHAM COMPARATOR

Stimulation on similar areas with lighter touch and shorter duration

Other: Sham intervention

Interventions

Osteopathic sympathic harmonization OTHER

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.

Osteopathy Group

Sham intervention OTHER

Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.

Control Group

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 20606239 BACKGROUND

• Pala 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.

  PMID: 38414339 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Omer Osman PALA, PhD

  Cumhuriyet University, Faculty of Health Sciences, Physiotherapy and Rehabilitation

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A double-blind, placebo-controlled, randomized study

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 9, 2021
• Study Start: October 11, 2017
• Primary Completion: March 23, 2018
• Study Completion: June 5, 2018
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: January 1, 2022

Locations

TU (1)