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13 May 2008
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| [ Print-friendly version ] |
| Classical ACupuncture Treatment for people with Unexplained Symptoms |
| ISRCTN | ISRCTN99754128 |
| ClinicalTrials.gov identifier | |
| Public title | Classical ACupuncture Treatment for people with Unexplained Symptoms |
| Scientific title | |
| Acronym | CACTUS study |
| Serial number at source | 1 |
| 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 | Ethics approval received from the Lewisham Research Ethics Committee (REC) on the 5th December 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. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Medically unexplained physical symptoms |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 31/10/2009 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) |
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. |
| Sources of funding | King's Fund (UK) - research grant (http://www.kingsfund.org.uk/) |
| Trial website | |
| Publications | |
| Contact name | Prof Nicky Britten |
| Address |
Institute of Health Service Research
Peninsula Medical School University of Exeter St Luke's Campus |
| City/town | Exeter |
| Zip/Postcode | EX1 2LU |
| Country | United Kingdom |
| Sponsor | Peninsula Medical School (UK) |
| Address |
Institute of Health Service Research
St Luke's Campus |
| City/town | Exeter |
| Zip/Postcode | EX1 2LU |
| Country | United Kingdom |
| Tel | +44 (0)1392 264859 |
| charlotte.paterson@pms.ac.uk | |
| Sponsor website: | http://www.pms.ac.uk/pms/ |
| Date applied | 05/10/2007 |
| Last edited | 10/04/2008 |
| Date ISRCTN assigned | 10/04/2008 |
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