Classical ACupuncture Treatment for people with Unexplained Symptoms

ISRCTN	ISRCTN99754128
DOI	https://doi.org/10.1186/ISRCTN99754128
Secondary identifying numbers	1

Submission date: 05/10/2007
Registration date: 10/04/2008
Last edited: 04/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nicky Britten
Scientific

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

Study information

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
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	CACTUS study
Study objectives	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(s)	Lewisham Research Ethics Committee (REC) on 05/12/2007 (ref: 07/H0810/54)
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2008
Completion date	31/10/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	31/10/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Health Service Research

Exeter
EX1 2LU
United Kingdom

Sponsor information

Peninsula Medical School (UK)
Hospital/treatment centre

Institute of Health Service Research
St Luke's Campus
Exeter
EX1 2LU
England
United Kingdom

Phone	+44 (0)1392 264859
Email	charlotte.paterson@pms.ac.uk
Website	http://www.pms.ac.uk/pms/
"ROR"	https://ror.org/04dtfyh05

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2011		Yes	No
Results article	results	01/06/2011		Yes	No