Acupuncture for irritable bowel syndrome: a pilot for a randomised controlled trial
| ISRCTN | ISRCTN32823720 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32823720 |
| Protocol serial number | N/A |
| Sponsor | University of York (UK) |
| Funder | University of York (UK) - Innovation and Research Priming Fund Award |
- Submission date
- 22/06/2006
- Registration date
- 04/10/2006
- Last edited
- 24/04/2009
- 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 Hugh MacPherson
Scientific
Scientific
Department of Health Sciences
Seebohm Rowntree Area 3
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321394 |
|---|---|
| hm18@york.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial pilot study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | That a randomised controlled trial is feasible and the design can be optimised on the basis of the pilot. |
| Ethics approval(s) | Solihull Local Research Ethics Committee approved on the 28th June 2006 (ref: 06/Q2706/3) |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome |
| Intervention | Group one: acupuncture plus usual General Practitioner (GP) care Group two: usual GP care alone |
| Intervention type | Other |
| Primary outcome measure(s) |
IBS Symptom Severity and Global Impact Score |
| Key secondary outcome measure(s) |
1. Quality of life |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Consulted in primary care in the previous two years 2. Diagnosed with Irritable Bowel Syndrome (IBS) which meets the Rome II criteria 3. Aged over 18 years |
| Key exclusion criteria | 1. Not currently having acupuncture 2. No haemophilia 3. Not diagnosed with cancer 4. No major abdominal surgery in the previous six months 5. Sufficient English to complete documentation |
| Date of first enrolment | 22/06/2006 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/03/2008 | Yes | No |
