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Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome

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ClinicalTrials.gov Identifier: NCT05687214
Recruitment Status : Completed
First Posted : January 18, 2023
Last Update Posted : February 1, 2023
Sponsor:
Collaborator:
Associazione Italiana Rett (AIRETT)
Information provided by (Responsible Party):
Meir Lotan, Ariel University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Rett Syndrome Other: Osteopathic manipulative treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blind parallel group-randomized design.
Masking: Single (Outcomes Assessor)
Masking Description: The assessors will not know which group the participants were assigned (experimental or control group) at any study stage.
Primary Purpose: Treatment
Official Title: Investigation on the Effects of an Osteopathic Manipulative Treatment for Constipation in People With Rett Syndrome
Actual Study Start Date : November 16, 2022
Actual Primary Completion Date : January 27, 2023
Actual Study Completion Date : January 27, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group
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

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.
No Intervention: Control Group
Participants in the control group will not receive any treatment.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05687214


Locations
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Italy
Centro AIRETT Ricerca e Innovazione (CARI)
Verona, Italy, 37122
Sponsors and Collaborators
Ariel University
Associazione Italiana Rett (AIRETT)
Investigators
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Principal Investigator: Rosa Angela Fabio, PhD Department of Clinical and Experimental Medicine, University of Messina
More Information
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Publications:
Balogh RS, Ouellette-Kuntz H, Brownell M, Colantonio A. Ambulatory Care Sensitive Conditions in Persons with an Intellectual Disability - Development of a Consensus. J Appl Res Intellect Disabil 2011;24:150-8. doi:10.1111/j.1468-3148.2010.00578.x.
Carr EG, Smith CE. Biological setting events for self-injury. Ment Retard Dev Disabil Res Rev 1995;1:94-8. doi:10.1002/mrdd.1410010204.
Christensen TJ, Ringdahl JE, Bosch JJ, Falcomata TS, Luke JR, Andelman MS. Constipation associated with self-injurious and aggressive behavior exhibited by a child diagnosed with autism. Educ Treat Child 2009;32:89-103. doi:10.1353/etc.0.0041.
Epstein LG. Rett Syndrome--Clinical and Biological Aspects: Studies on 130 Swedish Females. Arch Neurol 1995;52:343-4. doi:10.1001/archneur.1995.00540280025011.
Hagberg B, Anvret M, Wahlstrom J, Wahlström J. Rett syndrome-Clinical and biological aspects: Studies on 130 Swedish females. London: Cambridge University Press; 1993.
Bosch, J.; Mraz, R.; Masbruch, J.; Tabor, A.; Van Dyke, D.; McBrien, D. Constipation in Young Children with Developmental Disabilities. Infants Young Child 2002, 15, 66-77, doi:10.1097/00001163-200210000-00009.
Brugman, R.; Fitzgerald, K.; Fryer, G. The Effect of Osteopathic Treatment on Chronic Constipation - A Pilot Study. International Journal of Osteopathic Medicine 2010, 13, 17-23, doi:10.1016/j.ijosm.2009.10.002.
Smith, L.; Berkowitz, M.R. Osteopathic Approach to Chronic Constipation in Prader-Willi Syndrome: A Case Report. International Journal of Osteopathic Medicine 2016, 19, 73-77, doi:10.1016/J.IJOSM.2015.11.002.
Fabio, R.A.; Martinazzoli, C.; Antonietti, A. Development and Standardization of the "Rars"(Rett Assessment Rating Scale). Life Span Disabil 2005, 8, 257-281.
Milnes, K.; Moran, R.W. Physiological Effects of a CV4 Cranial Osteopathic Technique on Autonomic Nervous System Function: A Preliminary Investigation. International Journal of Osteopathic Medicine 2007, 10, 8-17, doi:10.1016/j.ijosm.2007.01.003.
Paoletti, S. Le Fasce: Il Ruolo Dei Tessuti Nella Meccanica Umana; ESOMM: Rome, IT, 2003; ISBN 0157347362.
Barral, J.P. Advanced Visceral Manipulation: Neuroendocrine Approach to the Abdomen; The Barral Institute: Ayr, UK, 2020; ISBN 9780998747965.
Bordoni, B.D. I Cinque Diaframmi. Medicina Manuale; Edi.Ermes: Milano, IT, 2021; ISBN 9788870517415.
Weischenck, J. Traité d Ostéopathie Viscérale; Maloine S.A.: Paris, FR, 1982; ISBN 9788874490929.
American Osteopathic Association Foundations of Osteopathic Medicine; Chila, A.G., Carreiro, J.E., Dowling, D.J., Gamber, R.G., Glover, J.C., Habenicht, A.L., Jerome, J.A., Patterson, M.M., Rogers, F.J., Seffinger, M.A., Willard, F.H., Eds.; 3rd ed.; Lippincott Williams & Wilkins: Philadelphia, PA, 2015; ISBN 9780781766715.
Kapandji, I.A. The Physiology of the Joints: The Spinal Column, Pelvic Girdle and Head; 7th ed.; Handspring Publishing: London, UK, 2019; ISBN 9781912085613.

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Responsible Party: Meir Lotan, Professor, Ariel University
ClinicalTrials.gov Identifier: NCT05687214    
Other Study ID Numbers: AU-HEA-ML-20220915
First Posted: January 18, 2023    Key Record Dates
Last Update Posted: February 1, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators plan to share the anonymized IPD related to participants' age, and levels of Rett syndrome severity, motor functioning, and daily physical activity. The information will be published as a part of the scientific articles produced after the study ends.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rett Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Mental Retardation, X-Linked
 Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System