Condition category
Digestive System
Date applied
22/06/2006
Date assigned
04/10/2006
Last edited
24/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.york.ac.uk/research

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

  1. Results

    Reynolds JA, Bland JM, MacPherson H, Acupuncture for irritable bowel syndrome an exploratory randomised controlled trial., Acupunct Med, 2008, 26, 1, 8-16.

Additional files

Editorial Notes