Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/04/2009
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

Dr Philip Tovey

ORCID ID

Contact details

University of Leeds
Centre for Research in Primary Care
30-32 Hyde Terrace
Leeds
LS2 9LN
United Kingdom
+44 (0)113 233 4838
p.a.tovey@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PCC1012R; RSU440900

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to provide the first systematic evidence on the potential of reflexology to improve symptoms for patients with irritable bowel syndrome (IBS). As a result the study provides evidence on:
1. The overall effectiveness of reflexology
2. Its impact on a range of physical and psychological symptoms
3. Potential cost-effectiveness
4. The extent to which benefits are dependent on the nature of touch

It contributes to more informed decision making for professionals and service users.

Ethics approval

Received from Local Ethics Committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Inflammatory bowel disease

Intervention

1. Experimental reflexology group
2. Control group

The reflexology experimental group were given six 30 minute treatment sessions over an eight week period conducted as closely as possible in line with 'normal practice'. The length of the sessions and the total number of those sessions was agreed with the lead reflexologist. The treatment consisted of an initial 'whole foot' massage followed by localised attention to the areas of the foot considered - within reflexology theory - to be related to IBS. The indistinguishable control group was given the same number of contact sessions as the experimental group and those sessions were carried out in exactly the same way, following the same procedures, with the single exception that a non-reflexology foot massage was given. According to reflexology theory this should have no curative effect as no stimulation of healing has occurred.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The study was designed to test the effectiveness of reflexology on the core defining symptoms of IBS and wider physical and psychological outcomes. The principal outcome measure was abdominal pain.

Secondary outcome measures

1. Constipation/diarrhoea
2. Bloatedness
3. Overall health
4. Personal well being
5. Tiredness
6. Anxiety

Overall trial start date

05/01/1998

Overall trial end date

06/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria were tightly defined:
1. Patients currently under the care of a primary care physician following referral to a Gastroenterologist
2. The diagnosis of IBS in line with the Rome Criteria
3. Exclusion of other causes of symptoms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant exclusion criteria

Previous use of reflexology

Recruitment start date

05/01/1998

Recruitment end date

06/01/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Leeds
LS2 9LN
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

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11791811

Publication citations

  1. Results

    Tovey P, A single-blind trial of reflexology for irritable bowel syndrome., Br J Gen Pract, 2002, 52, 474, 19-23.

Additional files

Editorial Notes