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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial

Published in: Trials | Issue 1/2017

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Abstract

Background

Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1–2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice.

Methods/design

A three-arm, parallel-group, multicentre randomised controlled trial.
Objectives: to determine whether standardised specialist-led habit training plus pelvic floor retraining using computerised biofeedback is more clinically effective than standardised specialist-led habit training alone; to determine whether outcomes are improved by stratification based on prior investigation of anorectal and colonic pathophysiology. Primary outcome measure is response to treatment, defined as a 0.4-point (10% of scale) or greater reduction in Patient Assessment of Constipation–Quality of Life (PAC-QOL) score 6 months after the end of treatment. Other outcomes up to 12 months include symptoms, quality of life, health economics, psychological health and qualitative experience.
Hypotheses: (1) habit training (HT) with computer-assisted direct visual biofeedback (HTBF) results in an average reduction in PAC-QOL score of 0.4 points at 6 months compared to HT alone in unselected adults with CC, (2) stratification to either HT or HTBF informed by pathophysiological investigation (INVEST) results in an average 0.4-point reduction in PAC-QOL score at 6 months compared with treatment not directed by investigations (No-INVEST).
Inclusion: chronic constipation in adults (aged 18–70 years) defined by self-reported symptom duration of more than 6 months; failure of previous laxatives or prokinetics and diet and lifestyle modifications. Consenting participants (n = 394) will be randomised to one of three arms in an allocation ratio of 3:3:2: [1] habit training, [2] habit training and biofeedback or [3] investigation-led allocation to one of these arms. Analysis will be on an intention-to-treat basis.

Discussion

This trial has the potential to answer some of the major outstanding questions in the management of chronic constipation, including whether costly invasive tests are warranted and whether computer-assisted direct visual biofeedback confers additional benefit to well-managed specialist advice alone.

Trial registration

International Standard Randomised Controlled Trial Number: ISRCTN11791740.​ Registered on 16 July 2015.
Appendix
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Literature
1.
Sonnenberg A, Koch T. Epidemiology of constipation in the United States. Dis Colon Rectum. 1989;32:1–8.CrossRefPubMed
2.
Stewart WF, Liberman JN, Sandler RS, Woods MS, Stemhagen A, Chee E. Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features. Am J Gastroenterol. 1999;94:3530–40.CrossRefPubMed
3.
van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006;101:240–9.
4.
McCrea GL, Miaskowski C, Stotts NA, Macera L, Paul SM, Varma MG. Gender differences in self-reported constipation characteristics, symptoms, and bowel and dietary habits among patients attending a specialty clinic for constipation. Gend Med. 2009;6:259–71.CrossRefPubMed
5.
Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best practice & research. Clin Gastroenterol. 2011;25:3–18.
6.
7.
Gallegos-Orozco JF, Foxx-Orenstein A, Sterler SM, Stoa JM. Chronic constipation in the elderly. Am J Gastroenterol. 2015;107:18–25.CrossRef
8.
Probert CS, Emmett PM, Heaton KW. Some determinants of whole-gut transit time: a population-based study. QJM. 1995;88:311–5.PubMed
9.
Cook IJ, Talley NJ, Benninga MA, Rao SS, Scott SM. Chronic constipation: overview and challenges. Neurogastroenterol Motil. 2009;21:1.CrossRefPubMed
10.
Knowles CH, Scott SM, Rayner C, Glia A, Lindberg G, Kamm MA. Idiopathic slow-transit constipation: an almost exclusively female disorder. Dis Colon Rectum. 2003;46:1716–7.CrossRefPubMed
11.
Wald A, Scarpignato C, Mueller-Lissner SA, Kamm MA, Hinkel U, Helfrich I. A multinational survey of prevalence and patterns of laxative use among adults with self-defined constipation. Aliment Pharmacol Ther. 2008;28:917–30.PubMed
12.
Irvine EJ, Ferrazzi S, Pare P, Thompson WG, Rance L. Health-related quality of life in functional GI disorders: focus on constipation and resource utilization. Am J Gastroenterol. 2002;97:1986–93.CrossRefPubMed
13.
Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012;143:1179–87. e1-3.CrossRefPubMedPubMedCentral
14.
Poulton B, Thomas S. The nursing cost of constipation. Prim Health Care. 1999;9:17–20.CrossRef
15.
Centre HaSCI. Prescribing and Primary Care Services, Health and Social Care Information Centre: prescriptions dispensed in the community: England 2002-12. England: Health and Social Care Information Centre; 2012.
16.
Scott SM, van den Berg MM, Benninga MA. Rectal sensorimotor dysfunction in constipation. Best practice & research. Clin Gastroenterol. 2011;25:103–18.
17.
Knowles CH, Dinning PG, Pescatori M, Rintala R, Rosen HR. Surgical management of constipation. Neurogastroenterol Mot. 2009;21:62–71.CrossRef
18.
19.
Bardisa-Ezcurra L, Ullman R, Gordon J. Diagnosis and management of idiopathic childhood constipation: summary of NICE guidance. BMJ. 2010;340:c2585.CrossRefPubMed
20.
Hooban S. NICE’s first guideline on idiopathic childhood constipation aims to standardise practice. Nurs Times. 2010;106:14.PubMed
21.
Norton C, Thomas L, Hill J. Management of faecal incontinence in adults: summary of NICE guidance. Br Med J. 2007;334:1370–1.CrossRef
22.
Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008;358:2344–54.CrossRefPubMed
23.
Lembo AJ, Cremonini F, Meyers N, Hickling R. Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation—a double-blind, randomized, placebo-controlled, study. Aliment Pharmacol Ther. 2010;31:979–90.PubMed
24.
Lembo AJ, Johanson JF, Parkman AP, Rao SS, Miner P, Ueno R. Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation. Dig Dis Sci. 2011;56:2639–45.CrossRefPubMedPubMedCentral
25.
Lembo AJ, Kurtz CB, Macdougal JE, Lavins BJ, Currie MG, Fitch DA. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010;135:886–95. e1.CrossRef
26.
Kamm MA, Dudding T, Melenhorst J, Jarret ME, Wang Z, Buntzen S, Johansson C, Laurberg S, Rosen HR, Vaizey CJ, Matzel KE, Baeten CG. Sacral nerve stimulation for intractable constipation. Gut. 2010;3:333–40.CrossRef
27.
Maeda Y, Lundby L, Buntzen S, Laurberg S. Sacral nerve stimulation for constipation: suboptimal outcome and adverse events. Dis Colon Rectum. 2010;53:995–9.CrossRefPubMed
28.
Knowles CH, Thin N, Bhan C, Grimmer K, Lunniss PJ. Prospective randomized double-blind study of temporary sacral nerve stimulation in patients with rectal evacuatory dysfunction and rectal hyposensitivity. Ann Surg. 2012;255:643–9.CrossRefPubMed
29.
Chiotakakou-Faliakou E, Kamm MA, Roy AJ, Storrie JB, Turner IC. Biofeedback provides long term benefit for patients with intractable, slow and normal transit constipation. Gut. 1998;42:517–21.CrossRefPubMed
30.
Bleijenberg G, Kuijpers HC. Biofeedback treatment of constipation: a comparison of two methods. Am J Gastroenterol. 1994;89:1021–6.PubMed
31.
Koutsomanis D, Lennard-Jones JE, Roy A, Kamm MA. Controlled randomised trial of visual biofeedback versus muscle training without a visual display for intractable constipation. Gut. 1995;37:95–9.CrossRefPubMedPubMedCentral
32.
Glia A, Gylin M, Gullberg K, Lindberg G. Biofeedback retraining in patients with functional constipation and paradoxical puborectalis contraction: comparison of anal manometry and sphincter electromyography for feedback. Dis Colon Rectum. 1997;40:889–95.CrossRefPubMed
33.
Heymen S, Wexner S, Vickers D, Nogueras JJ, Weiss EG, Pikarsky AJ. Prospective, randomized trial comparing four biofeedback techniques for patients with constipation. Dis Colon Rectum. 1999;42:1388–93.CrossRefPubMed
34.
Chiarioni G, Whitehead WE, Pezza V, Morelli A, Bassotti G. Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. Gastroenterology. 2006;130:657–64.CrossRefPubMed
35.
Heymen S, Scarlett Y, Jones K, Ringel Y, Drossman DA, Whitehead WE. Randomized, controlled trial shows biofeedback to be superior to alternative treatments for patients with pelvic floor dyssynergia-type constipation. Dis Colon Rectum. 2007;50:428–41.CrossRefPubMed
36.
Rao SS. Biofeedback therapy for constipation in adults. Best practice & research. Clin Gastroenterol. 2011;25:159–66.
37.
Bharucha AE, Dorn SD, Lembo AJ, Pressman A. American Gastroenterological Association medical position statement on constipation. Gastroenterology. 2013;144:211–7.CrossRefPubMed
38.
Enck P, Van der Voort IR, Klosterhalfen S. Biofeedback therapy in fecal incontinence and constipation. Neurogastroenterol Motil. 2009;21:1133–41.CrossRefPubMed
39.
40.
Dinning PG, Lorenzo C. Colonic dysmotility in constipation. Best practice & research. Clin Gastroenterol. 2011;25:89–101.
41.
Chiarioni G, Salandini L, Whitehead WE. Biofeedback benefits only patients with outlet dysfunction, not patients with isolated slow transit constipation. Gastroenterology. 2005;129:86–97.CrossRefPubMed
42.
Rao SS, Seaton K, Miller M, Brown K, Nygaard I, Stumbo P. Randomized controlled trial of biofeedback, sham feedback, and standard therapy for dyssynergic defecation. Clin Gastroenterol Hepatol. 2007;5:331–8.CrossRefPubMed
43.
Simon MA, Bueno AM. Behavioural treatment of the dyssynergic defecation in chronically constipated elderly patients: a randomized controlled trial. Appl Psychophysiol Biofeedback. 2009;34:273–7.CrossRefPubMed
44.
Lehur PA, Stuto A, Fantoli M, Villani RD, Queralto M, Lazorthes F, Hershman M, Carriero A, Pigot F, Meurette G, Narisetty P, Villet R, ODS II Study Group. Outcomes of stapled transanal rectal resection vs. biofeedback for the treatment of outlet obstruction associated with rectal intussusception and rectocele: a multicenter, randomized, controlled trial. Dis Colon Rectum. 2008;51:1611–8.CrossRefPubMed
45.
Farid M, El Monem HA, Omar W, El Nkeeb A, Fikry A, Youssef T. Comparative study between biofeedback retraining and botulinum neurotoxin in the treatment of anismus patients. Int J Colorectal Dis. 2009;24:115–20.CrossRefPubMed
46.
47.
Rao SS, Ozturk R, Laine L. Clinical utility of diagnostic tests for constipation in adults: a systematic review. Am J Gastroenterol. 2005;100:1605–15.CrossRefPubMed
48.
Locke GR, Pemberton JH, Phillips SF. American Gastroenterological Association technical review on constipation. Gastroenterology. 2000;119:1766–78.CrossRefPubMed
49.
Locke GR, Pemberton JH, Phillips SF. American Gastroenterological Association medical position statement: guidelines on constipation. Gastroenterology. 2000;119:1761–6.CrossRefPubMed
50.
Croffie JM, Ammar MS, Pfefferkorn MD, Horn D, Klipsch A, Fitzgerald JF. Assessment of the effectiveness of biofeedback in children with dyssynergic defecation and recalcitrant constipation/encopresis: does home biofeedback improve long-term outcomes. Clin Paediatr. 2005;44:63–71.CrossRef
51.
Rao SS, Singh S. Clinical utility of colonic and anorectal manometry in chronic constipation. J Clin Gastroenterol. 2010;44:597–609.CrossRefPubMed
52.
Bharucha AE, Wald A, Enck P, Rao SS. Functional anorectal disorders. Gastroenterology. 2006;130:1510–8.CrossRefPubMed
53.
Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006;130:1377–90.CrossRefPubMed
54.
American College of Gastroenterology Chronic Constipation Task Force. An evidence-based approach to the management of chronic constipation in North America. Gastroenterology. 2005;100:S1–4.
55.
56.
Collin C, Wade DT, Davies S, Horne V. The Barthel ADL Index: a reliability study. Int Disabil Stud. 1988;10:61–3.CrossRefPubMed
57.
Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10:64–7.CrossRefPubMed
58.
Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life Questionnaire. Scand J Gastroenterol. 2005;40:540–51.CrossRefPubMed
59.
Dubois D, Gilet H, Viala-Danten M, Tack J. Psychometric performance and clinical meaningfulness of the Patient Assessment of Constipation-Quality of Life Questionnaire in prucalopride (RESOLOR) trials for chronic constipation. Neurogastroenterol Motil. 2010;22:e54–63.CrossRefPubMed
60.
Tack J, Camilleri M, Dubois D. Association between health-related quality of life and symptoms in patients with chronic constipation: an integrated analysis of three phase 3 trials of prucalopride. Neurogastroenterol Motil. 2015;27:405.
61.
Frank L, Kleinman L, Farup C, Taylor L, Miner P. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999;34:870–7.CrossRefPubMed
62.
Herdman M, Gudex C, Lloyd A, Janssen MF, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L). Qual Life Res. 2011;20:1727–36.CrossRefPubMedPubMedCentral
63.
Curtis LNA. Unit costs of health and social care; Personal Social Services Research Unit. Canterbury: University of Kent; 2006.
64.
65.
Kroenke K, Spitzer RL, Williams JBW. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002;64:258–66.CrossRefPubMed
66.
Spitzer RL, Kroenke K, Williams JBW, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–7.CrossRefPubMed
67.
Slades PD, Owens RG. A dual process model of perfectionism based on reinforcement theory. Behav Modif. 1998;22:372–90.CrossRef
68.
Spence M, Moss-Morris R, Chalder T. The Behavioural Responses to Illness Questionnaire (BRIQ): a new predictive measure of medically unexplained symptoms following acute infection. Psychol Med. 2005;35:583–93.CrossRefPubMed
69.
Broadbent E, Petrie KJ, Weinman J. The Brief Illness Perception Questionnaire. J Psychosom Res. 2006;60:631–7.CrossRefPubMed
70.
71.
Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum. 1996;39:681–5.CrossRefPubMed
72.
Sletten DM, Suarez GA, Low PA, Mandrekar J, Singer W. COMPASS 31: a refined and abbreviated Composite Autonomic Symptom Score. Mayo Clin Proc. 2012;87:1196–201.CrossRefPubMedPubMedCentral
73.
Mishra MB, Ryan P, Atkinson P, Taylor H, Bell J, Calver D. Extra-articular features of benign joint hypermobility syndrome. Br J Rheumatol. 1996;996:9–861.
74.
75.
White IR, Royston P, Wood AM. Multiple imputation using chained equations: issues and guidance for practice. Stat Med. 2011;30:377–99.CrossRefPubMed
76.
77.
Jeong WK, Chung T-S, Lim S-W, Park JW, Lim S-B, Choi HS, Seung-Yong S-Y Jeong. Rectal perforation after anorectal manometry following preoperative chemoradiotherapy and low anterior resection—report of a case. J Korean Soc Coloproctol. 2008;24:298–301. doi:10.​3393/​jksc.​2008.​24.​4.​298.
78.
Sterne JAC, White IR, Carlin JB, Spratt M, Royston P, Kenward MG. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. Br Med J. 2009;338:b2393.CrossRef
79.
White IR, Horton N, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. Br Med J. 2011;342:d40.CrossRef
80.
Rao SS, Azpiroz F, Diamant NE, Enck P, Tougas G, Wald A. Minimum standards of anorectal manometry. Neurogastroenterol Motil. 2002;14:553–9.CrossRefPubMed
81.
Carrington EV, Brokjaer A, Craven H, Zarate N, Horrocks E, Palit S, Jackson G, Duthie CH, Knowles CH, Lunniss PJ, Scott SM. Traditional measures of normal anal sphincter function using high-resolution anorectal manometry (HRAM) in 115 healthy volunteers. Neurogastroenterol Motil. 2014;26:625–35.CrossRefPubMed
82.
Rao SS, Mudipalli RS, Stessman M, Zimmerman B. Investigation of the utility of colorectal function tests and Rome II criteria in dyssynergic defecation (anismus). Neurogastroenterol Motil. 2004;16(5):589–96.CrossRefPubMed
83.
84.
Ratuapli SK, Bharucha AE, Noelting J, Harvey DM, Zinsmeister AR. Phenotypic identification and classification of functional defecatory disorders using high-resolution anorectal manometry. Gastroenterology. 2013;144:314–22. e2.CrossRefPubMed
85.
Farthing MJG, Lennard-Jones JE. Sensibility of the rectum to distension and the anorectal distension reflex in ulcerative colitis. Gut. 1978;19:64–9.CrossRefPubMedPubMedCentral
86.
Jameson JS, Chia YW, Kamm MA, Speakman CTM, Chye YH, Henry MM. Effect of age, sex and parity on anorectal function. Br J Surg. 1994;81:1689–92.CrossRefPubMed
87.
Zarate N, Knowles CH, Newell M, Garvie NW, Gladman MA, Lunniss PJ, Scott SM. In patients with slow transit constipation, the pattern of colonic transit delay does not differentiate between those with and without impaired rectal function. Am J Gastroenterol. 2008;103:434.CrossRef
88.
Dedeli O, Turan I, Ozturk R, Bor S. Normative values of the balloon expulsion test in healthy adults. Turk J Gastroenterol. 2007;18:177–81.PubMed
89.
90.
Palit S, Bhan C, Lunniss PJ, Boyle DJ, Gladman MA, Knowles CH, Scott SM. Evacuation proctography: a reappraisal of normal variability. Colorectal Dis. 2014;16:538–46.CrossRefPubMed
91.
Evans RC, Kamm MA, Hinton JM, Lennard-Jones JE. The normal range and a simple diagram for recording whole gut transit-time. Int J Colorectal Dis. 1992;7:15–7.CrossRefPubMed
92.
Mahieu P, Pringot J, Bodart P. Defecography.1. Description of a new procedure and results in normal patients. Gastrointest Radiol. 1984;9:247–51.CrossRefPubMed
93.
Mahieu P, Pringot J, Bodart P. Defecography 2. Contribution to the diagnosis of defecation disorders. Gastrointest Radiol. 1984;9:253–61.CrossRefPubMed
94.
Roberts JP, Womack NR, Hallan RI, Thorpe AC, Williams NS. Evidence from dynamic integrated proctography to redefine anismus. Br J Surg. 1992;79:1213–5.CrossRefPubMed
95.
Womack NR, Williams NS, Holmfield JH, Morrison JFB, Simpkins KC. New method for the dynamic assessment of anorectal function in constipation. Br J Surg. 1985;72:994–8.CrossRefPubMed
96.
Shorvon PJ, McHugh F, Somers S, Stevenson GW. Defecographic findings in young healthy-volunteers. Gut. 1987;28:A1361–2.
Metadata
Title
Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial
Publication date
01-12-2017
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1880-0

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