| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN88306970 |
| Date ISRCTN assigned | 23/01/2004 |
| Local reference number(s) | PCC1012R RSU440900 |
| Public title | A Randomised Controlled Trial of a course of Reflexology on inflammatory bowel disease (IBS) in a Primary Care Setting |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Digestive system diseases: Inflammatory bowel disease |
| 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 IBS. As a result the study provides evidence on: the overall effectiveness of Reflexology; its impact on a range of physical and psychological symptoms; potential cost-effectiveness; the extent to which benefits are dependent on the nature of touch. It contributes to more informed decision making for professionals and service users. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Inclusion criteria were tightly defined: 'patients currently under the care of a primary care physician following referral to a Gastroenterologist; the diagnosis of IBS in line with the Rome Criteria; and therefore the exclusion of other causes of symptoms'. |
| Participants - exclusion criteria | Previous use of Reflexology |
| Patient information material |
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| Anticipated start date | 05/01/1998 |
| Anticipated end date | 06/01/2000 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | i. Experimental reflexology group
ii. 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. |
| Primary outcome measure(s) | 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; the other outcome measures were constipation/diarrhoea, bloatedness, overall health, personal well being, tiredness, and anxiety. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | NHS Executive Northern and Yorkshire |
| Sponsor name | NHS R&D Regional Programme Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr Philip Tovey |
| Contact details | University of Leeds
Centre for Research in Primary Care
30-32 Hyde Terrace
Leeds
United Kingdom
LS2 9LN |
| Contact telephone | +44 0113 2334838 |
| Contact fax | +44 0113 2334835 |
| Contact email | p.a.tovey@leeds.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN88306970 |
| Date last extracted from ISRCTN register | 17/04/2008 |
