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Classical ACupuncture Treatment for people with Unexplained Symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99754128
Enrollment
100
Registered
2008-04-10
Start date
2008-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medically unexplained physical symptoms Mental and Behavioural Disorders Somatoform disorders

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 sa

Sponsors

Peninsula Medical School (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026