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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.
-
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.