Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

Rett Syndrome Clinical Trial

Official title:

Investigation on the Effects of an Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05687214
• Other study ID #: AU-HEA-ML-20220915
• Status: Completed
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: January 27, 2023

Study information

• Verified date: January 2023
• Source: Ariel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of classic Rett syndrome with a mutation of the MECP2 gene;

• matching the ROME IV criteria for constipation;

Exclusion Criteria:

• the presence of specific severe heart and cardiovascular diseases;

• the presence of amenorrhea.

Related Conditions & MeSH terms

• Constipation
• Rett Syndrome
• Syndrome

Intervention

Other:
• Osteopathic manipulative treatment
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.

Locations

Country	Name	City	State
Italy	Centro AIRETT Ricerca e Innovazione (CARI)	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Ariel University	Associazione Italiana Rett (AIRETT)

Country where clinical trial is conducted

Italy, 

References & Publications (69)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Change in number of evacuations	The number of participants' evacuations collected daily by participants' caregivers	Every day, during the intervention phase (for 8 weeks).
Primary	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.
Primary	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.
Primary	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).
Primary	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.
Primary	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 a coefficient showed good internal consistency over time (a>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).
Primary	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).
Primary	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 (a>0.85).	15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Primary	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	Change in the tissue tension	The pelvic tissue tension was evaluated as an index of hydration and deep fascial tension. For the assessment, the iliac cavity skin was pinched between the index and thumb fingers, and a score between 0 (normal tissue elasticity) and 4 (adherent, rigid skin, tissue detachment not possible) was assigned based on the tissue elasticity.	15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Secondary	Change in the abdomen palpability	It represents an index of abdominal stiffness and refers to the intestinal skein resistance to manual mobilization in the supine position. The right and left colic cords, ileocecal valve, and sigma were mobilized. Based on the perceived tissue consistency and resistance, scores between 0 (soft and treatable abdominal tissue) and 3 (rigid abdomen, tense and painful even in the medium-deep palpation) points were assigned.	15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Secondary	Change in the abdominal bloating	It assesses the presence and extent of intestinal gas. It is helpful to have an approximate idea of the intestinal loops' opening (or closing) level. It was assessed by observing the prominence of the four abdominal quadrants in correspondence with the navel, anterior iliac thorns, and costal ramps. And a score between 0 (flat, compressible abdomen) and 4 (globose abdomen, total compressibility not possible) was assigned.	15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Secondary	Change in the sacral pad swelling	Its presence can indicate inadequate liquids' reabsorption in the small pelvis by the iliac branches. It is evaluated in the supine position by manual pressure examination of the sacral base. Based on the sacral area swelling, a score between 0 (normally distended sacral area) and 3 (large swelling with lumbar-sacral area tissue inhibition).	15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).