Behavioral Therapy in Patients With Rumination

NCT05232097 | Completed Results

• 2 other identifiers: HUS/23/2022HUS/2118/2021
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

The study aim is to diagnose patients with the rumination syndrome defined by the Rome IV criteria and to treat them with behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles. Before referral to the study, gastroscopy, esophageal hgh-resolution manometry and 24-hour esophageal pH and impedance monitoring are required to rule out other esophageal conditions. Twenty Finnish speaking, 15-70 years old patients will be enrolled in this open study. All patients will visit the gastroenterologist at onset of the study and at 6 months. All patients will be referred to the speech therapist for five one-hour sessions consisting of diaphragmatic belching exercises and to the physiotherapist for two one-hour sessions consisting of exercises to relax tensed thoracic and abdominal muscles. All patients will also visit once the psychologist and dietician. Symptoms will be evaluated by the Rome IV questionnaire for adult functional gastrointestinal diseases at onset and at the 6-month control. Health-related quality of life, depression, anxiety, functional capacity will be evaluated by specific questionnaires at onset of the study and at the 6-month control. Esophageal high-resolution manometry will be performed at the 6-month control.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• Rumination Score (Self-perceived Rumination Frequency)

  Rumination score measured by question 32 of the Rome 4 diagnostic questionnaire for adult functional gastrointestinal disorders. The question scores the rumination frequency as follows: "In the last 3 months, how often did food come back up into your mouth after you swallowed it ?, 0 = never, 1= fewer than 1 day a month, 2 = 1 day a month, 3 = 2-3 days a month, 4 = 1 day a week, 5 = 2-3 days a week, 6 = most days, 7 = every day, 8 = multiple times per day or all the time". Scale 0-8, the highest score indicating highest frequency of rumination.

  6-month control

Secondary Outcomes (6)

• Number of Patients With Abdominal Pressure Peaks of an Amplitude of 30 mmHg or Higher

  6-month control

• Health-related Quality of Life (15D)

  6-month control

• Functional Capacity (WHODAS 2.)

  6-month control

• Depression Score (BDI)

  6-month control

• Anxiety Score (BAI)

  6-month control

Study Arms (1)

Behavioral therapy

EXPERIMENTAL

Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles

Behavioral: Behavioral therapy; Behavioral: Physiotherapy

Interventions

Behavioral therapy BEHAVIORAL

Diaphragmatic breathing exercises

Behavioral therapy

Physiotherapy BEHAVIORAL

Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the psychophysical physiotherapist

Behavioral therapy

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Rome IV criteria for rumination syndrome fulfilled
• gastroscopy, esophageal HR-manometry and 24-hour pH-impedance monitoring performed before referral to study

You may not qualify if:

• eating disorder, BMI \<14, pregnancy, cognitive or other disorder that disallows behavioral therapy

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (2)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Helsinki University Hospital, Childrens' Hospital

Helsinki, 00029, Finland

Location

Related Publications (11)

• Halland M, Pandolfino J, Barba E. Diagnosis and Treatment of Rumination Syndrome. Clin Gastroenterol Hepatol. 2018 Oct;16(10):1549-1555. doi: 10.1016/j.cgh.2018.05.049. Epub 2018 Jun 12.

  PMID: 29902642 BACKGROUND

• Kessing BF, Bredenoord AJ, Smout AJ. Objective manometric criteria for the rumination syndrome. Am J Gastroenterol. 2014 Jan;109(1):52-9. doi: 10.1038/ajg.2013.428. Epub 2013 Dec 24.

  PMID: 24366235 BACKGROUND

• Barba E, Accarino A, Soldevilla A, Malagelada JR, Azpiroz F. Randomized, Placebo-Controlled Trial of Biofeedback for the Treatment of Rumination. Am J Gastroenterol. 2016 Jul;111(7):1007-13. doi: 10.1038/ajg.2016.197. Epub 2016 May 17.

  PMID: 27185077 BACKGROUND

• Halland M, Parthasarathy G, Bharucha AE, Katzka DA. Diaphragmatic breathing for rumination syndrome: efficacy and mechanisms of action. Neurogastroenterol Motil. 2016 Mar;28(3):384-91. doi: 10.1111/nmo.12737. Epub 2015 Dec 10.

  PMID: 26661735 BACKGROUND

• Muurinen T, Walamies M. [Rumination in a young woman]. Duodecim. 2015;131(1):76-9. Finnish.

  PMID: 26245059 BACKGROUND

• Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y. Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print.

  PMID: 27144634 BACKGROUND

• Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.

  PMID: 8991972 BACKGROUND

• Leyfer OT, Ruberg JL, Woodruff-Borden J. Examination of the utility of the Beck Anxiety Inventory and its factors as a screener for anxiety disorders. J Anxiety Disord. 2006;20(4):444-58. doi: 10.1016/j.janxdis.2005.05.004. Epub 2005 Jul 6.

  PMID: 16005177 BACKGROUND

• Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001 Jul;33(5):328-36. doi: 10.3109/07853890109002086.

  PMID: 11491191 BACKGROUND

• Federici S, Bracalenti M, Meloni F, Luciano JV. World Health Organization disability assessment schedule 2.0: An international systematic review. Disabil Rehabil. 2017 Nov;39(23):2347-2380. doi: 10.1080/09638288.2016.1223177. Epub 2016 Nov 7.

  PMID: 27820966 BACKGROUND

• Apajasalo M, Sintonen H, Holmberg C, Sinkkonen J, Aalberg V, Pihko H, Siimes MA, Kaitila I, Makela A, Rantakari K, Anttila R, Rautonen J. Quality of life in early adolescence: a sixteen-dimensional health-related measure (16D). Qual Life Res. 1996 Apr;5(2):205-11. doi: 10.1007/BF00434742.

  PMID: 8998489 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Behavior Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Therapeutics; Rehabilitation

Limitations and Caveats

The patient sample is very small, although we actively recruited patients for two years from the Helsinki University Central Hospital area covering 1.7 million people. This was an open study without any control group, but it would have been both difficult to create an alternative therapy for randomization and unethical given that the patients had difficult rumination occurring most days of the week.

Results Point of Contact

• Title: Dr. Jari Punkkinen
• Organization: Helsinki University Hospital

jari.punkkinen@hus.fi

+358 50 427 9864

Study Officials

• Jari Punkkinen, Dr

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Gastroenterology, Hyvinkää Hospital

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 9, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 18, 2024
• Results First Posted: November 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)