Clinical trial NCT04840043: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteopathic Manipulative Treatment
Keywords: Depression
Sympathetic nervous system
Cortisol
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 39
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, placebo-controlled, randomized study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Beck Depression Inventory (BDI)
timeFrame: Before intervention
measure: The State-Trait Anxiety Inventory (STAI) Form - 1
timeFrame: Before intervention
measure: Change from Baseline The State-Trait Anxiety Inventory (STAI) Form - 2 at 20 minutes
timeFrame: Before intervention, immediately after the intervention, 20 minutes after the intervention
measure: Change from Baseline Heart rate and blood pressure measurements at 20 minutes
timeFrame: Before intervention, immediately after the intervention, 20 minutes after the intervention
measure: Change from Baseline Salivary Biomarkers at 20 minutes
timeFrame: Before intervention, immediately after the intervention, 20 second after the intervention
measure: Demographic data
timeFrame: Before intervention
measure: Demographic data
timeFrame: Before intervention
measure: Demographic data
timeFrame: Before intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Si̇vas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Cumhuriyet University, Faculty of Health Sciences, Physiotherapy and Rehabilitation
name: Omer Osman PALA, PhD
role: STUDY_DIRECTOR
affiliation: Gazi University, Faculty of Health Sciences, Physiotherapy and Rehabilitation
name: Seyit CITAKER, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University, Faculty of Medicine, Child and Adolescent Psychiatry
name: Esra GUNEY, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University, Faculty of Medicine, Medical Biochemistry
name: Aylin SEPICI DINCEL, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University, Faculty of Medicine, Child and Adolescent Psychiatry
name: Güner Melike GUVELI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University, Faculty of Medicine, Medical Biochemistry
name: Burak ARSLAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.