Osteopathic Manipulative Treatment
Conditions
Keywords
Depression, Sympathetic nervous system, Cortisol
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.
Interventions
OTHEROsteopathic 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.
OTHERSham intervention
Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.
Sponsors
Cumhuriyet University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind trial
Intervention model description
A double-blind, placebo-controlled, randomized study
Eligibility
Sex/Gender
ALL
Age
15 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Beck Depression Inventory (BDI) | Before intervention | 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 | Before intervention | 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 Salivary Biomarkers at 20 minutes | Before intervention, immediately after the intervention, 20 second after the intervention | Salivary a-amylase and cortisol levels were measured for each sample. These biomarkers were analysed Enzyme-Linked Immunosorbent Assay. |
| Demographic data | Before intervention | Sex; male or female |
| Change from Baseline The State-Trait Anxiety Inventory (STAI) Form - 2 at 20 minutes | Before intervention, immediately after the intervention, 20 minutes after the intervention | 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 | Before intervention, immediately after the intervention, 20 minutes after the intervention | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed