Contact information
Type
Scientific
Primary contact
Dr Hugh MacPherson
ORCID ID
Contact details
Department of Health Sciences
Seebohm Rowntree Area 3
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321394
hm18@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
That a randomised controlled trial is feasible and the design can be optimised on the basis of the pilot.
Ethics approval
Solihull Local Research Ethics Committee approved on the 28th June 2006 (ref: 06/Q2706/3)
Study design
Randomised controlled trial pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Irritable bowel syndrome
Intervention
Group one: acupuncture plus usual General Practitioner (GP) care
Group two: usual GP care alone
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
22/06/2006
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
22/06/2006
Recruitment end date
30/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Health Sciences
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
University of York (UK)
Sponsor details
Research Support Office
Heslington
York
YO10 5DD
United Kingdom
smf3@york.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of York (UK) - Innovation and Research Priming Fund Award
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18356794
Publication citations
-
Results
Reynolds JA, Bland JM, MacPherson H, Acupuncture for irritable bowel syndrome an exploratory randomised controlled trial., Acupunct Med, 2008, 26, 1, 8-16.