Osteopathic Sympathetic Harmonization and Depression

Cumhuriyet University

Status: Completed

Conditions: Osteopathic Manipulative Treatment

Treatments: Other: Sham intervention; Other: Osteopathic sympathic harmonization

Study type: Interventional

Funder types: Other

Identifiers

NCT04840043

E-16-1106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 15 to 21 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

39 participants in 2 patient groups

Osteopathy Group

Experimental group

Description:

Stimulation on the sympathetic truncus and prevertebral ganglia

Treatment:

Other: Osteopathic sympathic harmonization

Control Group

Sham Comparator group

Description:

Stimulation on similar areas with lighter touch and shorter duration

Treatment:

Other: Sham intervention