Investigation on the Effects of an Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in the Short Form Health Survey-12 (SF-12)
研究概览
简要总结
Constipation consists of bowel symptoms characterized by difficulty or infrequency passage of stool, stiff stool, or a feeling of incomplete evacuation. However, its impact goes far beyond this definition. Constipation negatively impacts the quality of life (QoL) of children and adults suffering from this condition, affecting mental and physical-related QoL. Additionally, a negative impact of constipation on QoL was found in parents carrying children with constipation, affecting family functioning.
People with an intellectual disability present a constipation rate of over 33%. Rett syndrome (RTT) is a complex neurodevelopmental disorder affecting about 1/10,000 females and a few males worldwide. Chronic constipation is persistent in people with RTT, with a reported prevalence higher than 74%.
Specific recommendations for constipation management in RTT were developed, including behavioral, pharmacological, and surgical considerations. Recently, the literature has been enriched with papers describing the osteopathic treatment efficacy in reducing constipation. Emerging literature reported the efficacy of OMT in reducing constipation symptoms and improving QoL in typically developed people, as well as in children with disability. The present study aims to evaluate the efficacy of a specific OMT for managing chronic constipation in people with RTT and its impact on primary caregivers' quality of life.
Research questions:
- Can an OMT improve the constipation of people with RTT, increasing the frequency of bowel movements?
- Can the effects of an OMT aimed at reducing the constipation symptoms in people with RTT positively impact the participants' parents' constipation-related QoL?
Twelve individuals with RTT and their families will be recruited to participate in this single-blind parallel group-randomized study. Participants will be randomly divided into an experimental group (EG) and a control group (CG). After the preliminary evaluations, each participant will undergo eight OMT carried out weekly for eight weeks. The OMT will aim to facilitate bowel movements by increasing blood flow through the abdomen. At the end of the treatment, the participants will repeat the evaluation conducted before the OMT, and the collected data will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessors will not know which group the participants were assigned (experimental or control group) at any study stage.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of classic Rett syndrome with a mutation of the MECP2 gene;
- •matching the ROME IV criteria for constipation;
排除标准
- •the presence of specific severe heart and cardiovascular diseases;
- •the presence of amenorrhea.
结局指标
主要结局
Change in the Short Form Health Survey-12 (SF-12)
时间窗: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
The SF-12 is a multidimensional measure of health-related quality of life widely used in clinical trials. The SF-12 was administered to participants' primary caregivers. The Italian version of the SF-12 was validated on a large sample of Italian people showing strong psychometric proprieties.
Change in number of evacuations
时间窗: Every day, for one week, immediately after the end of the intervention phase.
The number of participants' evacuations collected daily by participants' caregivers
Change in theConstipation-Related Quality Of Life (CRQOL)
时间窗: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
The CRQOL assesses quality-of-life domains affected by constipation. It includes four domains: social impairment, distress, eating habits, and bathroom attitudes. In our study, the primary caregiver filled this scale reporting his feelings concerning the participant's constipation management. The internal consistency of each of the four domains was higher than 0.70 using Cronbach's alpha. Excellent test-retest reliability was demonstrated (α\>0.85).
Change in the Modified Constipation Assessment Scale (m-CAS)
时间窗: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
The m-CAS is an eight-item scale that measures whether constipation is present and its intensity. A higher score represents more severe constipation. Cronbach α coefficient showed good internal consistency over time (α\>0.70). The Pearson product-moment correlation coefficient was used to evaluate test-retest reliability and showed evident acceptance (r=0.93; P\<0.001).
Change in number of enemas and medications
时间窗: Every day, for one week, immediately after the end of the intervention phase.
The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.
Change in theConstipation Scoring System (CSS)
时间窗: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
The CSS assesses the severity of constipation with a maximum score of 30 (0 = no constipation, 30 = severe constipation. The scale was initially validated with a 100-subject sample and could correctly detect the absence or presence of constipation in 96% of the subjects, thus representing a sensitive and valid tool.
次要结局
- Change in the abdomen palpability(15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).)
- Change in the abdominal bloating(15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).)
- Change in the tissue tension(15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).)
- Change in the sacral pad swelling(15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).)