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Completed

NCT Number: NCT05687214

Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro AIRETT Ricerca e Innovazione (CARI)

Verona, 37122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in number of evacuations

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

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

  2. Change in number of evacuations

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

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

  3. Change in number of evacuations

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

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

  4. Change in number of enemas and medications

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

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

  5. Change in number of enemas and medications

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

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

  6. Change in number of enemas and medications

    Time frame: 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.

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

    Time frame: 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).

  8. Change in theConstipation Scoring System (CSS)

    Time frame: 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.

  9. Change in theConstipation-Related Quality Of Life (CRQOL)

    Time frame: 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).

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

    Time frame: 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.

Secondary outcomes

  1. Change in the tissue tension

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

    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.

  2. Change in the abdomen palpability

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

    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.

  3. Change in the abdominal bloating

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

    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.

  4. Change in the sacral pad swelling

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

    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).

Sponsors and collaborators

Lead sponsor

Ariel University

Other

Collaborators

  • Associazione Italiana Rett (AIRETT)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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