Acupuncture for irritable bowel syndrome: a pilot for a randomised controlled trial

ISRCTN ISRCTN32823720
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

Department of Health Sciences
Seebohm Rowntree Area 3
Heslington
York
YO10 5DD
United Kingdom

Phone +44 (0)1904 321394
Email hm18@york.ac.uk

Study information

Study designRandomised controlled trial pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThat 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) studiedIrritable bowel syndrome
InterventionGroup one: acupuncture plus usual General Practitioner (GP) care
Group two: usual GP care alone
Intervention typeOther
Primary outcome measureIBS Symptom Severity and Global Impact Score
Secondary outcome measures1. Quality of life
2. Anxiety and depression
3. Euro-QOL (EQ-5D) instrument
4. Medication and service use
Overall study start date22/06/2006
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Key inclusion criteria1. 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 criteria1. 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 enrolment22/06/2006
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Health Sciences
York
YO10 5DD
United Kingdom

Sponsor information

University of York (UK)
University/education

Research Support Office
Heslington
York
YO10 5DD
England
United Kingdom

Email smf3@york.ac.uk
Website http://www.york.ac.uk/research
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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