Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
05/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Marian Emly

ORCID ID

Contact details

Meanwood Park Hospital
Physiotherapy Department
Tongue Lane
Leeds
LS6 4QB
United Kingdom
+44 (0)113 275 8721

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PCC106X

Study information

Scientific title

Acronym

Study hypothesis

Adults with complex physical and learning disabilities frequently experience chronic constipation. The standard treatment is a combination of laxative and enema use. This does not always prove a satisfactory form of management and the inappropriate use of these drugs can cause colonic atony and other side effects. It has been suggested that abdominal massage, a safe and non-invasive technique, may provide an effective alternative. This study will measure gastro-intestinal transit time in this population and assess the relative effect on it of both massage and laxatives. Stool consistency, the requirement for enemas and patient well-being will also be assessed in order to evaluate the comparative merits of each treatment. The study population of approximately 36 adults will be drawn from residents of Meanwood Park Hospital who have cerebral palsy/abnormal muscle tone and who have been on regular laxative medication for over 12 months. Although the study group will vary in age, sex, level of mobility and drug management, a randomised cross-over design has been chosen to take account of patient heterogeneity by using intra-subject comparisons. If clinically proven, abdominal massage has the potential to contribute to safer and more effective practice in bowel management. Other benefits could include increased patient well-being, enhanced by the greater staff/carer involvement in their management, and the possible reduction in the requirement for laxatives. The value of this therapy could extend beyond the client group to be studied, and benefit a variety of patients who present with chronic constipation.

Ethics approval

Not provided at time of registration

Study design

Randomised cross-over design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nervous system diseases: cerebral palsy

Intervention

1. Abdominal massage
2. Regular laxative treatment

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Bowel management and patient well-being

Secondary outcome measures

Not provided at time of registration

Overall trial start date

18/09/1995

Overall trial end date

05/10/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Residential patients with cerebral palsy/abnormal muscle tone and who have been on regular laxative medication for over 12 months.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

18/09/1995

Recruitment end date

05/10/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Meanwood Park Hospital
Leeds
LS6 4QB
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes