Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666415
Status:
UNKNOWN
Last Update Posted:
2020-12-14
First Post:
2020-08-28
Brief Title:
Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa
Sponsor:
Institut Mutualiste Montsouris
Organization:
Institut Mutualiste Montsouris
Study Overview
Official Title:
Monocentric Single-blind Randomized Controlled Trial Evaluating the Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACAMTO
Brief Summary:
Abstract
Background Anorexia nervosa AN is a common pathology affecting mainly women sex ratio 110 which starts most often during adolescence The prognosis of the AN remains poor 10 of deaths and high risk of chronicity Body dissatisfaction disturbances in recognition and identification of body sensations are some of the key symptoms of AN There is however a contrast between this consensual observation of the importance of troubles in body image in AN and the relative deficit of specifically targeted body treatments Our proposal for a body approach specifically dedicated to AN is based on the understanding that posture breathing muscle tension and body perception are closely linked to our psychological and emotional state and are therefore disturbed in patients with AN
The purpose of this monocentric randomized controlled trial is to evaluate if a targeted osteopathic protocol treatment for AN in addition to as-usual care is significantly more effective compared to as-usual care
Methods Seventy-two female patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups one receiving the specific osteopathic treatment targeted for AN in addition to the as-usual care group A and the other one the as-usual care group B The patients of group A will receive 5 sessions of osteopathic treatment for 25 minutes Soft specific palpatory techniques on the diaphragm digestive system and cervical region will be realized The as-usual care is defined by the multidisciplinary approach recommended by the high authority of health The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms and assessment of somatic dysfonctions evolution A qualitative study will also be carried out applying the Interpretative Phenomenological Analysis method Patients will be included for a maximum of 14 weeks between the inclusion time and the last evaluation
Discussion
If the results of the study are positive statistically significant effectiveness of this body approach in addition to as-usual care compared to as-usual treatment patients with anorexia will be benefit from the possibility of additional treatment that is effective relatively inexpensive non-invasive and non-pharmacological
Background Anorexia nervosa AN is a common pathology affecting mainly women sex ratio 110 which starts most often during adolescence The prognosis of the AN remains poor 10 of deaths and high risk of chronicity Body dissatisfaction disturbances in recognition and identification of body sensations are some of the key symptoms of AN There is however a contrast between this consensual observation of the importance of troubles in body image in AN and the relative deficit of specifically targeted body treatments Our proposal for a body approach specifically dedicated to AN is based on the understanding that posture breathing muscle tension and body perception are closely linked to our psychological and emotional state and are therefore disturbed in patients with AN
The purpose of this monocentric randomized controlled trial is to evaluate if a targeted osteopathic protocol treatment for AN in addition to as-usual care is significantly more effective compared to as-usual care
Methods Seventy-two female patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups one receiving the specific osteopathic treatment targeted for AN in addition to the as-usual care group A and the other one the as-usual care group B The patients of group A will receive 5 sessions of osteopathic treatment for 25 minutes Soft specific palpatory techniques on the diaphragm digestive system and cervical region will be realized The as-usual care is defined by the multidisciplinary approach recommended by the high authority of health The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms and assessment of somatic dysfonctions evolution A qualitative study will also be carried out applying the Interpretative Phenomenological Analysis method Patients will be included for a maximum of 14 weeks between the inclusion time and the last evaluation
Discussion
If the results of the study are positive statistically significant effectiveness of this body approach in addition to as-usual care compared to as-usual treatment patients with anorexia will be benefit from the possibility of additional treatment that is effective relatively inexpensive non-invasive and non-pharmacological
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None