Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2018-01-11
2019-06-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Manual and Automatic Colonic Massage for Chronic Constipation.
NCT06695754
Investigation of Cortico-Rectal Pathways in Healthy Subjects and Constipated Patients
NCT01300897
Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects
NCT06294457
Usefulness of High Resolution Manometry in Constipation
NCT04623359
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
NCT05989763
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The trial includes a 2-week pre-intervention period with the usual constipation treatment without MOWOOT, followed by a 4-week intervention period consisting of 20 minutes' daily massage with MOWOOT (with or without the usual constipation treatment, as required by subject), followed by 1week wash-out period and finished by 2 weeks' post-intervention follow-up period. The same outcome measures will be assessed before and immediately after the treatment, and again after a washout period.
The principal endpoint of the procedure will be based on constipation improvement (complete bowel movements per week). The secondary endpoints will be based on chronic constipation defined as Rome III criteria assessed by the KESS score, Bristol scale, colonic transit time, dose of laxatives and/or other measures to assist defecation and quality of life. These secondary endpoints regarding defecatory function will be evaluated during intervention and compared with 2 weeks before intervention and 2 weeks after intervention following one week of wash out.
The null hypothesis (H0) is that there is no difference between before and after treatment, against an alternative hypothesis (H1) assuming a difference between the treatments.
Two tailed tests with 95% confidence intervals will be produced for the comparisons of interest in order to investigate the magnitude of treatment effects.
MOWOOT is a "wearable" medical device which emulates the massage techniques used by the professional therapists in order to provide a colon-specific abdominal massage. The product is focused on people who suffer from chronic constipation due to neurogenic bowel disease and prolonged intestinal transit time.
MOWOOT is composed by two main pieces: the desktop device and the massager belt. The desktop device provides the source of energy as well as it contains the panel control which allows the management of the device function and allows to select the treatment time and pressure. The massager belt is connected to the desktop device and is the component which is in contact with the subject giving the abdominal massage action.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
Additionally, in order to discuss and analyse the results, further subgroups could be made on the basis of aetiology of the chronic constipation to compare results, i.e.: subjects with constipation derived from Neurogenic Bowel Disease (NBD) vs Idiopathic (No NBD) subjects whose constipation is from unknown origin
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
chronically constipated people
Adults with chronic constipation due to either neurogenic bowel dysfunction (NBD) as consequence of a neurogenic condition such as Multiple sclerosis or Parkinson Disease, or to unkwon origin (Idiopathic No-NBD)
intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device
The MOWOOT massager belt is connected to the desktop device and is the component which is in contact with the subject giving the abdominal massage action.
The massager belt, which is placed on the user's abdominal area, administers a specific abdominal massage on the ascendant and descendent segments of the colon. This massage emulates the techniques used by professional therapists through a series of pneumatic actuators operating like the movement of a wave transmitting movement through the colon. The type and speed of the massage can usually be regulated by an algorithm that controls the operation from the desktop device.
For the present clinical trial, time and force will stay fixed on 20 minutes and force 3 (0'6-0'7 bar). Subjects will not be able to choose other massage options. Subjects should use the MOWOOT device once a day for 20 min (1 complete treatment) ideally at the same hour every day for the 4 weeks of the interventional treatment period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device
The MOWOOT massager belt is connected to the desktop device and is the component which is in contact with the subject giving the abdominal massage action.
The massager belt, which is placed on the user's abdominal area, administers a specific abdominal massage on the ascendant and descendent segments of the colon. This massage emulates the techniques used by professional therapists through a series of pneumatic actuators operating like the movement of a wave transmitting movement through the colon. The type and speed of the massage can usually be regulated by an algorithm that controls the operation from the desktop device.
For the present clinical trial, time and force will stay fixed on 20 minutes and force 3 (0'6-0'7 bar). Subjects will not be able to choose other massage options. Subjects should use the MOWOOT device once a day for 20 min (1 complete treatment) ideally at the same hour every day for the 4 weeks of the interventional treatment period.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Failed routine management of constipation (lack of response to non-stimulant laxatives), or subjects responding to laxative treatment but with secondary diarrhoea and faecal incontinence.
* Duration of constipation more than 6 months.
* If subjects have a diagnosis of multiple sclerosis (MS) or Parkinson disease (PD), it is in a stable phase (no major change in medication for 1 month).
* Subject that have had no abdominal massage for at least 2 months.
* Subjects bothered by their constipation.
* Ability to understand the study
* Ability to come to the outpatient clinic during the study
* Subjects whose constipation aetiology is not only pelvic floor dyssynergia.
* Ability to use MOWOOT or have someone to apply it.
* Subjects that consent to participate in an informed way
Exclusion Criteria
* Subjects alternating constipation and diarrhoea (not due to laxative use)
* Previous large bowel surgery
* The presence of a stoma
* External rectal prolapse
* Active anorexia or bulimia
* Mental inability to give informed consent
* Active abdominal cancer
* Large inguinal or umbilical hernia
* Inflammatory Bowel Disease (IBD)
* Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
* Intra-abdominal implants (catheters, SARS, medication pumps…)
* Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 month.
* Inability to undertake the massage with the device themselves or the lack of a carer willing to do it.
* Participation in another parallel clinical trial or less than 2 month from participation in a previous clinical trial
* Subjects who do not consent to participate.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
usMIMA S.L.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Immaculada Herrero-Fresneda, PhD
Role: STUDY_CHAIR
usMIMA S.L.
Doreen McClurg, PhD
Role: PRINCIPAL_INVESTIGATOR
Glasgow Caledonian University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitari MútuaTerrassa
Terrassa, Barcelona, Spain
Glasgow Caledonian University
Glasgow, Scotland, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ayas S, Leblebici B, Sozay S, Bayramoglu M, Niron EA. The effect of abdominal massage on bowel function in patients with spinal cord injury. Am J Phys Med Rehabil. 2006 Dec;85(12):951-5. doi: 10.1097/01.phm.0000247649.00219.c0.
Azpiroz F, Enck P, Whitehead WE. Anorectal functional testing: review of collective experience. Am J Gastroenterol. 2002 Feb;97(2):232-40. doi: 10.1111/j.1572-0241.2002.05450.x.
Bracci F, Badiali D, Pezzotti P, Scivoletto G, Fuoco U, Di Lucente L, Petrelli A, Corazziari E. Chronic constipation in hemiplegic patients. World J Gastroenterol. 2007 Aug 7;13(29):3967-72. doi: 10.3748/wjg.v13.i29.3967.
Coggrave M, Wiesel PH, Norton C. Management of faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD002115. doi: 10.1002/14651858.CD002115.pub3.
Diego MA, Field T, Hernandez-Reif M, Deeds O, Ascencio A, Begert G. Preterm infant massage elicits consistent increases in vagal activity and gastric motility that are associated with greater weight gain. Acta Paediatr. 2007 Nov;96(11):1588-91. doi: 10.1111/j.1651-2227.2007.00476.x. Epub 2007 Sep 21.
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 Feb;7(1):15-7. doi: 10.1007/BF01647654.
Harari D, Norton C, Lockwood L, Swift C. Treatment of constipation and fecal incontinence in stroke patients: randomized controlled trial. Stroke. 2004 Nov;35(11):2549-55. doi: 10.1161/01.STR.0000144684.46826.62. Epub 2004 Oct 14.
Knowles CH, Eccersley AJ, Scott SM, Walker SM, Reeves B, Lunniss PJ. Linear discriminant analysis of symptoms in patients with chronic constipation: validation of a new scoring system (KESS). Dis Colon Rectum. 2000 Oct;43(10):1419-26. doi: 10.1007/BF02236639.
Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
Liu Z, Sakakibara R, Odaka T, Uchiyama T, Yamamoto T, Ito T, Hattori T. Mechanism of abdominal massage for difficult defecation in a patient with myelopathy (HAM/TSP). J Neurol. 2005 Oct;252(10):1280-2. doi: 10.1007/s00415-005-0825-9. Epub 2005 May 20. No abstract available.
Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
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 May;40(5):540-51. doi: 10.1080/00365520510012208.
McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.
Ng C, Prott G, Rutkowski S, Li Y, Hansen R, Kellow J, Malcolm A. Gastrointestinal symptoms in spinal cord injury: relationships with level of injury and psychologic factors. Dis Colon Rectum. 2005 Aug;48(8):1562-8. doi: 10.1007/s10350-005-0061-5.
Nortvedt MW, Riise T, Frugard J, Mohn J, Bakke A, Skar AB, Nyland H, Glad SB, Myhr KM. Prevalence of bladder, bowel and sexual problems among multiple sclerosis patients two to five years after diagnosis. Mult Scler. 2007 Jan;13(1):106-12. doi: 10.1177/1352458506071210.
Pfeiffer RF. Gastrointestinal Dysfunction in Parkinson's Disease. Curr Treat Options Neurol. 2018 Oct 25;20(12):54. doi: 10.1007/s11940-018-0539-9.
Rao SS, Azpiroz F, Diamant N, Enck P, Tougas G, Wald A. Minimum standards of anorectal manometry. Neurogastroenterol Motil. 2002 Oct;14(5):553-9. doi: 10.1046/j.1365-2982.2002.00352.x. No abstract available.
Ribas Y, Saldana E, Marti-Rague J, Clave P. Prevalence and pathophysiology of functional constipation among women in Catalonia, Spain. Dis Colon Rectum. 2011 Dec;54(12):1560-9. doi: 10.1097/DCR.0b013e31822cb5c2.
Sakakibara R, Yamaguchi C, Uchiyama T, Ito T, Liu Z, Yamamoto T, Awa Y, Yamanishi T, Hattori T. Pelvic autonomic dysfunction without paraplegia: a sequel of spinal cord stroke. Eur Neurol. 2008;60(2):97-100. doi: 10.1159/000138960. Epub 2008 Jun 14. No abstract available.
Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.
Stewart WF, Liberman JN, Sandler RS, Woods MS, Stemhagen A, Chee E, Lipton RB, Farup CE. Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features. Am J Gastroenterol. 1999 Dec;94(12):3530-40. doi: 10.1111/j.1572-0241.1999.01642.x.
Su Y, Zhang X, Zeng J, Pei Z, Cheung RT, Zhou QP, Ling L, Yu J, Tan J, Zhang Z. New-onset constipation at acute stage after first stroke: incidence, risk factors, and impact on the stroke outcome. Stroke. 2009 Apr;40(4):1304-9. doi: 10.1161/STROKEAHA.108.534776. Epub 2009 Feb 19.
Talley NJ. Definitions, epidemiology, and impact of chronic constipation. Rev Gastroenterol Disord. 2004;4 Suppl 2:S3-S10.
Ullman T, Reding M. Gastrointestinal dysfunction in stroke. Semin Neurol. 1996 Sep;16(3):269-75. doi: 10.1055/s-2008-1040984. No abstract available.
Winge K, Rasmussen D, Werdelin LM. Constipation in neurological diseases. J Neurol Neurosurg Psychiatry. 2003 Jan;74(1):13-9. doi: 10.1136/jnnp.74.1.13.
Wolters ECh. Non-motor extranigral signs and symptoms in Parkinson's disease. Parkinsonism Relat Disord. 2009 Dec;15 Suppl 3:S6-12. doi: 10.1016/S1353-8020(09)70770-9.
Wood LD, Neumiller JJ, Setter SM, Dobbins EK. Clinical review of treatment options for select nonmotor symptoms of Parkinson's disease. Am J Geriatr Pharmacother. 2010 Aug;8(4):294-315. doi: 10.1016/j.amjopharm.2010.08.002.
McClurg D, Booth L, Herrero-Fresneda I. Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00267. doi: 10.14309/ctg.0000000000000267.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MOW-01-2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.