Clinical trial NCT05687214: Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome
Official title: Investigation on the Effects of an Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rett Syndrome
Lead sponsor: Ariel University
Sponsor class: OTHER
Collaborators: name: Associazione Italiana Rett (AIRETT)
First posted: 2023-01-18
Enrollment: 12
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind parallel group-randomized design.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in number of evacuations
timeFrame: Every day, for one week, immediately before the intervention phase.
measure: Change in number of evacuations
timeFrame: Every day, during the intervention phase (for 8 weeks).
measure: Change in number of evacuations
timeFrame: Every day, for one week, immediately after the end of the intervention phase.
measure: Change in number of enemas and medications
timeFrame: Every day, for one week, immediately before the intervention phase.
measure: Change in number of enemas and medications
timeFrame: Every day, during the intervention phase (for 8 weeks).
measure: Change in number of enemas and medications
timeFrame: Every day, for one week, immediately after the end of the intervention phase.
measure: Change in the Modified Constipation Assessment Scale (m-CAS)
timeFrame: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
measure: Change in theConstipation Scoring System (CSS)
timeFrame: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
measure: Change in theConstipation-Related Quality Of Life (CRQOL)
timeFrame: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
measure: Change in the Short Form Health Survey-12 (SF-12)
timeFrame: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Secondary outcomes:
measure: Change in the tissue tension
timeFrame: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
measure: Change in the abdomen palpability
timeFrame: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
measure: Change in the abdominal bloating
timeFrame: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
measure: Change in the sacral pad swelling
timeFrame: 15 minutes. Before the treatment initiation (T0) and after the treatment end (T1 - after 8 weeks from T0).
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Centro AIRETT Ricerca e Innovazione (CARI)
Study officials:
affiliation: Department of Clinical and Experimental Medicine, University of Messina
name: Rosa Angela Fabio, PhD
role: PRINCIPAL_INVESTIGATOR
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