Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

NCT05687214 | Completed

• 1 other identifier: AU-HEA-ML-20220915
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rett Syndrome

Outcome Measures

Primary Outcomes (10)

• Change in number of evacuations

  The number of participants' evacuations collected daily by participants' caregivers

  Every day, for one week, immediately before the intervention phase.

• Change in number of evacuations

  The number of participants' evacuations collected daily by participants' caregivers

  Every day, during the intervention phase (for 8 weeks).

• Change in number of evacuations

  The number of participants' evacuations collected daily by participants' caregivers

  Every day, for one week, immediately after the end of the intervention phase.

• Change in number of enemas and medications

  The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.

  Every day, for one week, immediately before the intervention phase.

• Change in number of enemas and medications

  The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.

  Every day, during the intervention phase (for 8 weeks).

• Change in number of enemas and medications

  The number of enemas and medication provided to the participants' to simplify or induce the evacuations collected by their caregivers.

  Every day, for one week, immediately after the end of the intervention phase.

• Change in the Modified Constipation Assessment Scale (m-CAS)

  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).

  15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

• Change in theConstipation Scoring System (CSS)

  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.

  15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

• Change in theConstipation-Related Quality Of Life (CRQOL)

  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).

  15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

• Change in the Short Form Health Survey-12 (SF-12)

  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.

  15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

Secondary Outcomes (4)

• 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 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 sacral pad swelling

  15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).

Study Arms (2)

Experimental group

EXPERIMENTAL

Each participant in the experimental group will receive eight weekly osteopathic manipulative treatments within eight weeks. Each treatment session will include several specific manipulations.

Other: Osteopathic manipulative treatment

Control Group

NO INTERVENTION

Participants in the control group will not receive any treatment.

Interventions

Osteopathic manipulative treatment OTHER

Each participant in the experimental group will receive eight osteopathic manipulative treatments. Each treatment will include the following manipulations: * Pompage Cv4; * Occipital-sternal technique; * Relaxining manipulation of the diaphragmatic domes; * Pelvic and abdominal diaphragm synchronization; * Dynamogenic technique; * Mesenteric traction; * Release of colic angles; * Manipulation and mobilization of the sacrum.

Experimental group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of classic Rett syndrome with a mutation of the MECP2 gene;
• matching the ROME IV criteria for constipation;

You may not qualify if:

• the presence of specific severe heart and cardiovascular diseases;
• the presence of amenorrhea.

Sponsors & Collaborators

• Ariel University: lead
• Associazione Italiana Rett (AIRETT): collaborator

Study Sites (1)

Centro AIRETT Ricerca e Innovazione (CARI)

Verona, 37122, Italy

Location

Related Publications (69)

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MeSH Terms

Conditions

Rett Syndrome

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rosa Angela Fabio, PhD

  Department of Clinical and Experimental Medicine, University of Messina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will not know which group the participants were assigned (experimental or control group) at any study stage.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-blind parallel group-randomized design.

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 18, 2023
• Study Start: November 16, 2022
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: The IPD will be available if and when scientific articles related to this study are published. Should the data be published, they will be available indefinitely in the scientific literature.
• Access Criteria: The investigators plan to submit scientific articles related to the present study to be published in an open access peer-review scientific journal. Therefore, if the articles are published, the data will be available on the website of the journal in which they were published.

Locations

IT (1)