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| ID | Type | Description | Link |
|---|---|---|---|
| HUS/2118/2021 | Other Identifier | HUCS Ethics Committee |
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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.
Background: Rumination is a subconscious but a volitional, behavioral disorder. Contraction of the abdominal muscles results in an increase of abdominal pressure and a subsequent regurgitation of recently ingested food, followed by rechewing, reswallowing or spitting (1). The diagnosis is based on the Rome IV criteria for functional gastrointestinal disorders and esophageal high-resolution manometry (1, 2). Behavioral therapy consisting of diaphragmatic breathing exercises has proven efficient in these patients (3, 4). Psychophysical physiotherapy was effective in a published patient case (5).
Aim: The study aim is to diagnose patients with rumination syndrome defined by the Rome IV criteria and to treat them with behavioral therapy. The primary aim is a reduction of two points ore more in the rumination frequency measured by the Rome IV questionnaire for adult functional gastrointestinal diseases (6). Secondary aims are improved esophageal high-resolution manometry, health-related quality of life, and functional capacity and reduced anxiety and depression scores.
Patients: 20 Finnish speaking, 15-70 years old patients with rumination symptoms fulfilling the Rome IV criteria will be enrolled in this open study. Before referral to Helsinki University Central Hospital, gastroscopy, esophageal high-resolution manometry and esophageal 24-hour pH and impedance monitoring are required. Adolescents of 15 to 17 years old are referred to the childrens' gastroenterologist and adults 18 years or older are referred to the gastroenterologist. The inclusion criteria consist of rumination symtoms fulfilling the Rome IV criteria but esophageal high-resolution manometry may be negative because rumination cannot be always provoked during the study.The exclusion criteria comprise eating disorder, BMI <14, pregnancy, cognitive or other disorder that disallows behavioral therapy
Methods: Symptoms will be evaluated by the Rome IV questionnaire for adult functional gastrointestinal diseases in all patients. Health-related quality of life will be evaluated by 15D, a 15-dimensional measure of health-related quality of life, depression by Beck Depression Inventory (BDI), anxiety by the Beck Anxiety Inventory (BAI), and functional capacity by WHODAS 2.0, World Health Organization disability assesment schedule 2.0 in the patients 18 years or older (7-10). In the patients 15-17 years old, health-related qualiy of life will be evaluated by 16D, a sixteen-dimensional health-related measure for adolescents (11). All questionnaires will be carried out at the onset of the study and at the 6-month control. Esophageal high-resolution manometry will be performed at the 6-month control.
After the baseline visit to the gastroenterologist, patients will be sent to the speech therapist for five, one-hour sessions consisting of diaphragmatic breathing exercises and to a psychophysical physiotherapist for two one-hours sessions aiming at body-awareness to sense tensed thoracic and abdominal muscles and to relax them through guided exercises. Patients will continue these exercises at home during meals. All patient l visit the psychologist and dietician once to rule out eating disorders and other psychopathological conditions and will be referred to the psychiatrist when necessary. Esophageal high-resolution manometry will be performed at the 6-month control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral therapy | Experimental | Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral therapy | Behavioral | Diaphragmatic breathing exercises |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Abdominal Pressure Peaks of an Amplitude of 30 mmHg or Higher | Number of patients with abdominal pressure peaks of an amplitude of 30 mm Hg or higher measured by means of esophageal high-reselution manometry indicating rumination. | 6-month control |
| Health-related Quality of Life (15D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jari Punkkinen, Dr | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | 00029 | Finland | |||
| Helsinki University Hospital, Childrens' Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29902642 | Background | 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. | |
| 24366235 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Therapy | Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles Behavioral therapy: Diaphragmatic breathing exercises Physiotherapy: 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 body-mind orientated physiotherapist |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Therapy | Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles Behavioral therapy: Diaphragmatic breathing exercises Physiotherapy: 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 body-mind orientated physiotherapist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The 10 patients who finished the study. | Posted | Median | Inter-Quartile Range | score on a scale | 6-month control |
|
6 months
Adverse events were not assessed systematically but possible arverse effects were registered at the 6-month control.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Therapy | Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles Behavioral therapy: Diaphragmatic breathing exercises Physiotherapy: 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 Eleven (11) patients participated in the study. One patient was withdrawn from the study because of severe anxiety by doctor´s decision. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jari Punkkinen | Helsinki University Hospital | +358 50 427 9864 | jari.punkkinen@hus.fi |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2024 | Sep 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| 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 |
|
The 15D, a 15-dimensional measure of health-related quality of life includes 15 dimensions: breathing, mental function, speech, vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression, each scored from 1 (best possible) to 0 (worst possible). The 15D score, a single index number calculated over all the dimensions, is ranged from the maximum score 1 (no problems on any dimension) to the minimum score 0 (being dead). |
| 6-month control |
| Functional Capacity (WHODAS 2.) | WHODAS 2.0, the WHO Disability Assessment Schedule 2.0 questionnaire, covers six domains of functioning, including: Cognition - understanding & communicating, Mobility- moving & getting around, Self-care- hygiene, dressing, eating & staying alone, Getting along- interacting with other people, Life activities- domestic responsibilities, leisure, work & school, and Participation- joining in community activities. Each domain is ranged from 0 (no disability) to 100 (full disability). The WHODAS 2.0 summary score consisting of all six domains is converted to metric ranging from 0 to 100, with 0 indicating no disability and 100 full disability. | 6-month control |
| Depression Score (BDI) | Beck Depression Inventory (BDI) Score, scale 0-63. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression. | 6-month control |
| Anxiety Score (BAI) | Beck Anxiety Inventory (BAI) Score, scale 0-63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). | 6-month control |
| Weight | Weight in kilograms | 6-month control |
| Helsinki |
| 00029 |
| Finland |
| 27185077 | 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. |
| 26661735 | 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. |
| 26245059 | Background | Muurinen T, Walamies M. [Rumination in a young woman]. Duodecim. 2015;131(1):76-9. Finnish. |
| 27144634 | 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. |
| 8991972 | 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. |
| 16005177 | 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. |
| 11491191 | 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. |
| 27820966 | 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. |
| 8998489 | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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". | Median | Inter-Quartile Range | units on a scale |
|
| Anxiety score (BAI) | Beck Anxiety Inventory (BAI) Score. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). | Median | Inter-Quartile Range | Units on a score |
|
| Depression score (BDI) | Beck Depression Inventory (BDI) Score, scale 0-63. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression. | Median | Inter-Quartile Range | Score on scale |
|
| Healt-related quality of life (15D) | The 15-dimensional measure of health-related quality of life (15D) includes 15 dimensions: breathing, mental function, speech, vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression, each scored from 1 (best possible) to 0 (worst possible). The 15D score, a single index number over all the dimensions, is calculated with the maximum score 1 (no problems on any dimension) and the minimum score 0 (being dead). | Mean | Standard Deviation | units on a scale |
|
| Functional capacity (WHODAS 2.0) | The World Health Organization disability assessment schedule 2.0 (WHODAS 2.0) produces domain-specific scores for six different functioning domains -cognition, mobility, self-care, getting along, life activities (household and work) and participation. Each domain is scored from 0 (no disability) to 100 (full disability). The summary score is converted into a metric ranging from 0 to 100, where 0 = no disability and 100 = full disability. | Median | Inter-Quartile Range | units on a scale |
|
| Weight | Weigth in kilograms | Median | Inter-Quartile Range | kilograms |
|
|
|
|
| Secondary | Number of Patients With Abdominal Pressure Peaks of an Amplitude of 30 mmHg or Higher | Number of patients with abdominal pressure peaks of an amplitude of 30 mm Hg or higher measured by means of esophageal high-reselution manometry indicating rumination. | The 9 patients who were performed manometry at the 6-month control. Out of the 10 patients who finished the study, one refused. | Posted | Count of Participants | Participants | 6-month control |
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|
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| Secondary | Health-related Quality of Life (15D) | The 15D, a 15-dimensional measure of health-related quality of life includes 15 dimensions: breathing, mental function, speech, vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression, each scored from 1 (best possible) to 0 (worst possible). The 15D score, a single index number calculated over all the dimensions, is ranged from the maximum score 1 (no problems on any dimension) to the minimum score 0 (being dead). | The 8 patients who returned the 15D-questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 did not return the questionnaire at the 6-month control. | Posted | Mean | Standard Deviation | units on a scale | 6-month control |
|
|
|
|
| Secondary | Functional Capacity (WHODAS 2.) | WHODAS 2.0, the WHO Disability Assessment Schedule 2.0 questionnaire, covers six domains of functioning, including: Cognition - understanding & communicating, Mobility- moving & getting around, Self-care- hygiene, dressing, eating & staying alone, Getting along- interacting with other people, Life activities- domestic responsibilities, leisure, work & school, and Participation- joining in community activities. Each domain is ranged from 0 (no disability) to 100 (full disability). The WHODAS 2.0 summary score consisting of all six domains is converted to metric ranging from 0 to 100, with 0 indicating no disability and 100 full disability. | The 8 patients who returned the WHODAS 2.0 questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 patients did not return the questionnaire at the 6-month control. | Posted | Median | Inter-Quartile Range | units on a scale | 6-month control |
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| Secondary | Depression Score (BDI) | Beck Depression Inventory (BDI) Score, scale 0-63. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression. | The 8 patients who returned the BDI-questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 did not return the questionnaire at the 6-month control. | Posted | Median | Inter-Quartile Range | score on a scale | 6-month control |
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| Secondary | Anxiety Score (BAI) | Beck Anxiety Inventory (BAI) Score, scale 0-63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). | The 8 patients who returned the BAI questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 did not return the questionnaire at the 6-month control. | Posted | Median | Inter-Quartile Range | score on a scale | 6-month control |
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| Secondary | Weight | Weight in kilograms | All 10 patients who finished the study. | Posted | Median | Inter-Quartile Range | kilogram | 6-month control |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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