Multiple SclerosisAMBERNCT03166007
Abdominal Massage for Bowel Dysfunction
A study testing Abdominal massage and Optimised bowel care in people with Multiple Sclerosis, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Abdominal massage and Optimised bowel care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Caledonian University - NMAHP RU
Glasgow, Glasgow City of, G4 0BA
About this study
Official title: Abdominal Massage for Neurogenic Bowel Dysfunction in People With Multiple Sclerosis (AMBER Abdominal Massage for Bowel Dysfunction Effectiveness Research).
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Abdominal massage, Optimised bowel care
- Keywords
- Multiple Sclerosis, Neurogenic Bowel Dysfunction, Abdominal massage
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal massageBehavioural
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.
Optimised bowel careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimised bowel care + abdominal massage | Experimental | 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. Receives: Behavioral: Abdominal massage; Behavioral: Optimised bowel care |
| Optimised bowel care | Active comparator | 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. Receives: Behavioral: Optimised bowel care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 24 weeks Neurogenic Bowel Dysfunction Score (NBDs)
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.
Measured: Baseline - 24 weeks
Secondary outcomes (11)
Neurogenic Bowel Dysfunction Questionnaire (NBD PROM) - change in Score from Baseline to 24 weeks
Measured: Baseline - 24 weeks
Constipation Symptoms (Constipation Scoring System (CSS)) - change in Score from Baseline to 24 weeks
Measured: Baseline - 24 weeks
Bowel Symptoms (7 day diary) - change in Score from Baseline to 24 weeks
Measured: Baseline - 24 weeks
Radio Opaque Marker transit tests - change in Score from Baseline to 24 weeks
One Site only
Measured: Baseline - 24 weeks
Adherence to massage schedule (7 day diary) - change in Score from Baseline to 24 weeks
Intervention arm only
Measured: Baseline - 24 weeks
Bladder Function (Qualiveen Questionnaire Short Form) - change in Score from Baseline to 24 weeks
Measured: Baseline - 24 weeks
Health Status (EQ-5D-5L Health Questionnaire) - change in Score from Baseline to 24 weeks
Measured: Baseline - 24 weeks
Change of medication (Concomitant Medication Form)
Measured: Over the study duration (24 weeks)
Patient Resource Questionnaire - cost and use of NHS services (£)
Measured: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks
Patient Resource Questionnaire - cost to the patients and their families/carers (£)
Measured: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks
Patient Resource Questionnaire - incremental costs, QALYs and incremental cost per QALY derived by the economic model (£)
Measured: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startJun 2014
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doreen McClurg, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166007
- Sponsor's protocol ID
- 12/127
- Acronym
- AMBER
- Status last verified
- May 2017
- First submitted
- 25 May 2016
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Results will be published, lay summaries produced and massage training guidelines (+DVD) will be made available.
Publications
Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.
PubMed 39470206McClurg D, Harris F, Goodman K, Doran S, Hagen S, Treweek S, Norton C, Coggrave M, Norrie J, Rauchhaus P, Donnan P, Emmanuel A, Manoukian S, Mason H. Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT. Health Technol Assess. 2018 Oct;22(58):1-134. doi: 10.3310/hta22580.
PubMed 30375324
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Massage for Neurogenic Bowel Dysfunction in People With Multiple Sclerosis (AMBER Abdominal Massage for Bowel Dysfunction Effectiveness Research).
- ClinicalTrials.gov ID
- NCT03166007
- Acronym / sponsor ID
- AMBER / 12/127
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Neurogenic Bowel Dysfunction, Abdominal massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimised bowel care + abdominal massage | Experimental | Behavioral: Abdominal massage, Behavioral: Optimised bowel careIn 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. |
| Optimised bowel care | Active comparator | Behavioral: Optimised bowel careDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal massageThe 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. | Behavioural | Optimised bowel care + abdominal massage |
| Optimised bowel careDuring 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. | Behavioural | Optimised bowel care, Optimised bowel care + abdominal massage |
Primary outcome
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.
11 secondary outcomes
Neurogenic Bowel Dysfunction Questionnaire (NBD PROM) - change in Score from Baseline to 24 weeks
Time frame: Baseline - 24 weeks
Constipation Symptoms (Constipation Scoring System (CSS)) - change in Score from Baseline to 24 weeks
Time frame: Baseline - 24 weeks
Bowel Symptoms (7 day diary) - change in Score from Baseline to 24 weeks
Time frame: Baseline - 24 weeks
Radio Opaque Marker transit tests - change in Score from Baseline to 24 weeks
Time frame: Baseline - 24 weeks
Adherence to massage schedule (7 day diary) - change in Score from Baseline to 24 weeks
Time frame: Baseline - 24 weeks
Bladder Function (Qualiveen Questionnaire Short Form) - change in Score from Baseline to 24 weeks
Time frame: Baseline - 24 weeks
Health Status (EQ-5D-5L Health Questionnaire) - change in Score from Baseline to 24 weeks
Time frame: Baseline - 24 weeks
Change of medication (Concomitant Medication Form)
Time frame: Over the study duration (24 weeks)
Patient Resource Questionnaire - cost and use of NHS services (£)
Time frame: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks
Patient Resource Questionnaire - cost to the patients and their families/carers (£)
Time frame: Baseline, 1-6weeks, 12 weeks, 18 weeks and 24 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Derived from this study: PubMed 39470206Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.
- Derived from this study: PubMed 30375324McClurg D, Harris F, Goodman K, Doran S, Hagen S, Treweek S, Norton C, Coggrave M, Norrie J, Rauchhaus P, Donnan P, Emmanuel A, Manoukian S, Mason H. Abdominal massage plus advice, compared with advice only, for neurogenic bowel dysfunction in MS: a RCT. Health Technol Assess. 2018 Oct;22(58):1-134. doi: 10.3310/hta22580.
- Individual participant dataSharing planned: Yes. Results will be published, lay summaries produced and massage training guidelines (+DVD) will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doreen McClurg principal investigator
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal massage and Optimised bowel care in people with Multiple Sclerosis, run by Glasgow Caledonian University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to 24 weeks Neurogenic Bowel Dysfunction Score (NBDs) (time frame: Baseline - 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166007, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.