A randomised controlled trial of a course of reflexology on irritable bowel syndrome (IBS) in a primary care setting
| ISRCTN | ISRCTN88306970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88306970 |
| Secondary identifying numbers | PCC1012R; RSU440900 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip Tovey
Scientific
Scientific
University of Leeds
Centre for Research in Primary Care
30-32 Hyde Terrace
Leeds
LS2 9LN
United Kingdom
| Phone | +44 (0)113 233 4838 |
|---|---|
| p.a.tovey@leeds.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Received from Local Ethics Committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 05/01/1998 |
| Completion date | 06/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 34 |
| Key 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 |
| Key exclusion criteria | Previous use of reflexology |
| Date of first enrolment | 05/01/1998 |
| Date of final enrolment | 06/01/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leeds
Leeds
LS2 9LN
United Kingdom
LS2 9LN
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2002 | Yes | No |
