Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Abdominal Massage for Bowel Dysfunction (AMBER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03166007
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Glasgow Caledonian University

Brief Summary:
The aim of the AMBER trial is to determine the effectiveness and cost effectiveness of abdominal massage as part of the adjunct to bowel care in people with Multiple Sclerosis who have problems with their bowel i.e. faecal incontinence and/or constipation.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Abdominal massage Behavioral: Optimised bowel care Not Applicable

Detailed Description:

Neurogenic bowel dysfunction (NBD: constipation and/or faecal incontinence) is common in people with multiple sclerosis (MS) and is rated as the most severe impact of their disease/injury, above wheelchair dependence. Despite this, current treatment options are limited, poorly evaluated and complex.

This research aims to find out whether abdominal massage can help improve the symptoms of NBD in these patients. A small study has already shown that it is possible for patients or carers to perform abdominal massage and in some cases this helped the patient with their symptoms. A larger study is now required to confirm the results one way or another.

Patients with Multiple Sclerosis who attend one of the participating study centres who are bothered by constipation and or faecal incontinence will be asked to take part if they fit the other requirements for the trial. Those who agree to take part will be allocated at random to one of two groups, one will receive advice on the management of bowel dysfunction (called optimised bowel care), and the other will receive the same advice and will be taught how to do the abdominal massage (called abdominal massage and optimised bowel care). Both groups will visit a specialist nurse for 1 additional hour after their normal clinical appointment, or at an agreed time, to receive optimised bowel care advice. The patients in the intervention group +/or their carers will receive training on abdominal massage and a DVD/copy of demonstration of the massage for home use. All patients will also be called weekly for 6 weeks to discuss their bowel care.

The investigators will measure the results of treatment after 6 and 24 weeks. The investigators are primarily interested in whether patients in the intervention group (receiving optimized bowel care & abdominal massage) have had more of an improvement in their NBD score at 24 weeks after they start the study that the control group (receiving optimized bowel care only). The investigators also want to find out how bad the constipation and bowel symptoms are, how much this affects their life and if they have any problems with their bladder. The investigators will also measure the costs of the treatments and any costs to the patient and their family, and balance these against any benefits of the intervention treatment.

During the trial the investigators will assess how well the optimized bowel care and abdominal massage training was delivered by speaking with nurses and listening to recordings of some of the telephone calls. The investigators will talk to the patients to find how they perceive the treatment they received and how they got on during the treatment period and once the treatment finished. The investigators will explore how the treatment delivery and patient's perceptions impact on the patients NBD symptoms.

The investigators have worked out from previous research that if 200 patients take part and most complete the trial, there will be enough data to successfully compare the treatments to find out if one is better than the other. Individual participation will be entirely voluntary and the investigators do not believe there are any risks associated with taking part.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Abdominal Massage for Neurogenic Bowel Dysfunction in People With Multiple Sclerosis (AMBER Abdominal Massage for Bowel Dysfunction Effectiveness Research).
Study Start Date : June 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Optimised bowel care + abdominal massage
In addition to optimised bowel care as described below for the control group, the Intervention Nurse will teach the participant and/or their carer in the intervention arm how to deliver the abdominal massage. This will include viewing the massage DVD and the abdominal massage training booklet, as well as the demonstration of the technique on the participant by the Intervention Nurse.
Behavioral: Abdominal massage
The participant should be supine and in a relaxed atmosphere, though this may depend on level of disability. The massage comprises 4 basic strokes (10minutes); Stroking from the small of the back over the iliac crest and down both sides of the pelvis towards the groin; Effleurage follows the direction of the ascending colon across the transverse colon and down the descending colon. This is repeated several times with increasing pressure; Palmar kneading tracks down the descending colon up the ascending colon and down the descending colon once again. Effleurage is repeated and continued with a relaxing transverse stroke over the abdomen; Vibration over the abdominal wall to relieve flatus concludes the massage session. The participants in this group will receive one telephone call per week for 6 weeks and again at 24 weeks to further discuss their bowel management.

Behavioral: Optimised bowel care
During a 1 hour outpatient appointment, the participants' existing bowel care routine will be reviewed and optimised. For example, explaining the necessity of adequate fluid intake. No change in medication will be advocated. The participants in this group will also receive one telephone call per week during the following 6 week period to further discuss their bowel management and again at 24 week time point.

Active Comparator: Optimised bowel care
During a 1 hour outpatient appointment, the participants' existing bowel care routine will be reviewed and optimised. For example, explaining the necessity of adequate fluid intake. No change in medication will be advocated.
Behavioral: Optimised bowel care
During a 1 hour outpatient appointment, the participants' existing bowel care routine will be reviewed and optimised. For example, explaining the necessity of adequate fluid intake. No change in medication will be advocated. The participants in this group will also receive one telephone call per week during the following 6 week period to further discuss their bowel management and again at 24 week time point.




Primary Outcome Measures :
  1. Change from Baseline to 24 weeks Neurogenic Bowel Dysfunction Score (NBDs) [ Time Frame: Baseline - 24 weeks ]
    NBDs is a 10 item questionnaire covering frequency of bowel movements, headache, perspiration or discomfort during defecation; medication for constipation or faecal incontinence; time spent on defecation; frequency of digital stimulation or evacuation; frequency of faecal incontinence; flatus incontinence; and perianal skin problems. Maximum score is 47 with over 14 considered severe.


Secondary Outcome Measures :
  1. Neurogenic Bowel Dysfunction Questionnaire (NBD PROM) - change in Score from Baseline to 24 weeks [ Time Frame: Baseline - 24 weeks ]
  2. Constipation Symptoms (Constipation Scoring System (CSS)) - change in Score from Baseline to 24 weeks [ Time Frame: Baseline - 24 weeks ]
  3. Bowel Symptoms (7 day diary) - change in Score from Baseline to 24 weeks [ Time Frame: Baseline - 24 weeks ]
  4. Radio Opaque Marker transit tests - change in Score from Baseline to 24 weeks [ Time Frame: Baseline - 24 weeks ]
    One Site only

  5. Adherence to massage schedule (7 day diary) - change in Score from Baseline to 24 weeks [ Time Frame: Baseline - 24 weeks ]
    Intervention arm only

  6. Bladder Function (Qualiveen Questionnaire Short Form) - change in Score from Baseline to 24 weeks [ Time Frame: Baseline - 24 weeks ]
  7. Health Status (EQ-5D-5L Health Questionnaire) - change in Score from Baseline to 24 weeks [ Time Frame: Baseline - 24 weeks ]
  8. Change of medication (Concomitant Medication Form) [ Time Frame: Over the study duration (24 weeks) ]
  9. Patient Resource Questionnaire - cost and use of NHS services (£) [ Time Frame: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks ]
  10. Patient Resource Questionnaire - cost to the patients and their families/carers (£) [ Time Frame: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks ]
  11. Patient Resource Questionnaire - incremental costs, QALYs and incremental cost per QALY derived by the economic model (£) [ Time Frame: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female over the age of 18 years;
  • Diagnosis of MS (in a stable phase i.e. no MS relapse for 3 months);
  • No major change of medication for 1 month e.g. introduction of disease modifying medications;
  • Individual is bothered by their bowel dysfunction, and;
  • Must not have used abdominal massage for at least 2 months.

Exclusion Criteria:

  • Individuals who are unable to undertake the massage themselves or do not have a carer willing to do it;
  • Individuals who are unable to understand the study processes;
  • Individuals who have contraindications to abdominal massage e.g. history of abdominal/pelvic cancer, hiatus, inguinal or umbilical hernia, rectal prolapse, Inflammatory Bowel Disease, pregnancy and past history of volvulus.
  • Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable.

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): NCT03166007


Locations
Layout table for location information
United Kingdom
Glasgow Caledonian University - NMAHP RU
Glasgow, Glasgow city of, United Kingdom, G4 0BA
Sponsors and Collaborators
Glasgow Caledonian University
Investigators
Layout table for investigator information
Principal Investigator: Doreen McClurg Glasgow Caledonian University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT03166007     History of Changes
Other Study ID Numbers: 12/127
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be published, lay summaries produced and massage training guidelines (+DVD) will be made available.
Keywords provided by Glasgow Caledonian University:
Multiple Sclerosis
Neurogenic Bowel Dysfunction
Abdominal massage
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Gastrointestinal Diseases
Digestive System Diseases