Condition category
Mental and Behavioural Disorders
Date applied
05/10/2007
Date assigned
10/04/2008
Last edited
04/08/2011
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

Prof Nicky Britten

ORCID ID

Contact details

Institute of Health Service Research
Peninsula Medical School
University of Exeter
St Luke's Campus
Exeter
EX1 2LU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

CACTUS study

Study hypothesis

1. In patients who attend frequently in primary care with medically unexplained physical symptoms that have persisted for more than three months, does the addition of five-element acupuncture to usual General Practitioner (GP) care, compared to usual care alone, improve self-reported health, increase health-improving behaviours, and reduce conventional medication and general practice consultation rates?
2. How do these patients experience the process and effects of acupuncture, how do they integrate it with conventional medical care and self-care, and how does it affect their use of other health care resources?

Ethics approval

Lewisham Research Ethics Committee (REC) on 05/12/2007 (ref: 07/H0810/54)

Study design

A pragmatic randomised trial of usual care versus acupuncture plus usual care, with a nested qualitative study involving interviews with patients.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Medically unexplained physical symptoms

Intervention

Both groups will receive usual care. The intervention group will also receive up to twelve sessions of classical five-element acupuncture over a six month period. The control group will receive the same acupuncture intervention after a six month period. The two groups will be followed up for two years.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary quantitative outcome will be change in health status, from baseline to end of six months treatment, as measured by the Measure Yourself Medical Outcome Profile (MYMOP) questionnaire. MYMOP is a brief individualised questionnaire that measures change in two symptoms, one activity of daily living and general wellbeing, all measured on a seven point scale, and combined to give a single MYMOP profile score.

Secondary outcome measures

1. Change in health status and wellbeing as measured by:
1.1. General Wellbeing Questionnaire (GW-B12), which has three dimensions of energy, negative wellbeing (includes anxiety and depression), and positive wellbeing
1.2. Patient Enablement Instrument
1.3. Medication Change Questionnaire, a detailed measure of medication in a weekly diary format
1.4. EuroQol-5D, a brief generic outcome questionnaire
2. Health resource use:
2.1. GP consultation rates from practice computers
2.2. Other health resource use by self-report
3. Change in health-improving behaviours and self-care: primarily by qualitative methods

Secondary outcomes measured at 3, 6, 12 and 24 months after randomisation.

Overall trial start date

01/01/2008

Overall trial end date

31/10/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Fulfill the ‘Peveler’ criteria for medically unexplained symptoms:
1. Present to GP consultation with:
1.1. The presentation of a physical symptom
1.2. The symptom had existed for at least three months
1.3. It had caused clinically significant distress or impairment
1.4. It could not be explained by physical disease. The definition of this point will be clarified by adding that of Burton (2003), as ‘physical symptoms for which no clear or consistent organic pathology can be demonstrated’
2. Have a GP consultation rate of eight or more in the previous 12 months
3. Over 18 years, male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Under 18 years of age
2. Insufficient cognitive ability to complete the self-report questionnaires
3. Insufficient mobility and/or available transport to attend surgery for acupuncture treatment
4. Pregnant
5. A co-existent life-threatening condition, psychotic illness, severe substance abuse
6. Acupuncture treatment in the previous six months

Recruitment start date

01/01/2008

Recruitment end date

31/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health Service Research
Exeter
EX1 2LU
United Kingdom

Sponsor information

Organisation

Peninsula Medical School (UK)

Sponsor details

Institute of Health Service Research
St Luke's Campus
Exeter
EX1 2LU
United Kingdom
+44 (0)1392 264859
charlotte.paterson@pms.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.pms.ac.uk/pms/

Funders

Funder type

Research organisation

Funder name

King's Fund (UK) - research grant (http://www.kingsfund.org.uk/)

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21801508
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21801509

Publication citations

  1. Results

    Paterson C, Taylor RS, Griffiths P, Britten N, Rugg S, Bridges J, McCallum B, Kite G, , Acupuncture for 'frequent attenders' with medically unexplained symptoms: a randomised controlled trial (CACTUS study)., Br J Gen Pract, 2011, 61, 587, e295-305, doi: 10.3399/bjgp11X572689.

  2. Results

    Rugg S, Paterson C, Britten N, Bridges J, Griffiths P, Traditional acupuncture for people with medically unexplained symptoms: a longitudinal qualitative study of patients' experiences., Br J Gen Pract, 2011, 61, 587, e306-15, doi: 10.3399/bjgp11X577972.

Additional files

Editorial Notes