Acupuncture for irritable bowel syndrome: a pilot for a randomised controlled trial
ISRCTN | ISRCTN32823720 |
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DOI | https://doi.org/10.1186/ISRCTN32823720 |
Secondary identifying numbers | N/A |
- 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 |
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hm18@york.ac.uk |
Study information
Study design | Randomised controlled trial pilot study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | IBS Symptom Severity and Global Impact Score |
Secondary outcome measures | 1. Quality of life 2. Anxiety and depression 3. Euro-QOL (EQ-5D) instrument 4. Medication and service use |
Overall study start date | 22/06/2006 |
Completion date | 30/06/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Sponsor information
University of York (UK)
University/education
University/education
Research Support Office
Heslington
York
YO10 5DD
England
United Kingdom
smf3@york.ac.uk | |
Website | http://www.york.ac.uk/research |
https://ror.org/04m01e293 |
Funders
Funder type
University/education
University of York (UK) - Innovation and Research Priming Fund Award
No information available
Results and Publications
Intention to publish date | |
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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 | 01/03/2008 | Yes | No |