Adolescent and Young adult psychiatry Unit, Institut Mutualiste Montsouris, 42 boulevard Jourdan, 75014, Paris, France.
Osteopath, 101 rue de Javel, 75015, Paris, France.
Trials. 2021 Nov 24;22(1):839. doi: 10.1186/s13063-021-05810-8.
Anorexia nervosa (AN) mainly affects women (sex ratio 1/10) and most often starts during adolescence. The prognosis of 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. However, there is a contrast between this consensual observation of body image disorders 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 treatment as usual (TAU) is significantly more effective than TAU alone.
In total, 72 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 TAU (group A) and the other one, receiving TAU only (group B). The patients in group A will receive 5 30-min osteopathic treatment sessions. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be performed. The TAU is defined by the multidisciplinary approach recommended by the French health high authority. The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms with assessment of somatic dysfunctions' 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.
If the results of the study are positive (statistically significant efficacy of this osteopathic treatment protocol), the study will provide arguments in favor of osteopathic sessions as a possible non-invasive additional treatment option in the multidisciplinary care approach for patients with AN.
ClinicalTrials.gov ID: NCT04666415 , Release Date: December 11, 2020; N° ID-RCB: 2019-A02613-54.
神经性厌食症（AN）主要影响女性（性别比为 1/10），且多数在青春期开始发病。AN 的预后仍然较差（10%的死亡率和高慢性风险）。身体不满、对身体感觉的识别和认知障碍是 AN 的一些关键症状。然而，在 AN 中对身体形象障碍的这种共识观察与针对身体的专门治疗相对不足之间存在对比。我们提出了一种专门针对 AN 的身体方法，其基础是理解姿势、呼吸、肌肉紧张和身体感知与我们的心理和情绪状态密切相关，因此在 AN 患者中受到干扰。这项单中心随机对照试验的目的是评估针对 AN 的特定整骨治疗方案是否比常规治疗（TAU）单独治疗更有效。
共有 72 名符合纳入标准的患者将被随机分配到两个治疗组之一：一组接受针对 AN 的特定整骨治疗加 TAU（A 组），另一组仅接受 TAU（B 组）。A 组的患者将接受 5 次 30 分钟的整骨治疗。将对膈膜、消化系统和颈部进行柔软的特定触诊技术。TAU 由法国卫生高级管理局推荐的多学科方法定义。主要结果是评估内脏感觉敏感性，次要结果包括临床和精神病理学相关症状以及评估躯体功能障碍的演变。还将进行定性研究，应用解释现象学分析方法。患者将在纳入时间和最后评估之间最多 14 周内纳入。
如果研究结果为阳性（该整骨治疗方案具有统计学意义的疗效），则该研究将为整骨治疗作为 AN 多学科护理方法的一种可能的非侵入性附加治疗选择提供依据。
ClinicalTrials.gov ID：NCT04666415，发布日期：2020 年 12 月 11 日；N° ID-RCB：2019-A02613-54。
