Condition category
Not Applicable
Date applied
23/01/2013
Date assigned
30/12/2014
Last edited
30/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Somatic complaints are physical complaints that can’t be explained medically. They are estimated to cost the NHS around £3.2 billion a year. Symptoms reported are both numerous and varied. They can include palpitations, chest pains, gastrointestinal problems (e.g. nausea, vomiting, diarrhoea), muscle and joint pains, headaches, feeling dizzy, loss of sex drive and problems with the menstrual cycle. Patients with somatic complaints often suffer from depression, anxiety or other mental health problems. They are often told that their symptoms are “all in their head”, which can lead to a worsening of their symptoms and a detrimental effect on their everyday life. There is a big demand for rigorous investigation into more therapeutically intense treatments (or interventions) for somatic complaints to help alleviate pressure on the NHS. Here, we want to look at whether Traditional Chinese Acupuncture (TCA) can help alleviate symptoms in patients with somatic complaints.

Who can participate?
Adults aged 18-65 that have medically unexplained physical symptoms.

What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 are given 5 sessions of TCA. Those in group 2 are given a “placebo” acupuncture treatment. A special device is used to ensure that neither the practitioner or patient knows whether the needles are penetrating the skin. Patients are asked to report on their symptoms and fill in a general heath questionnaire before they start their first acupuncture session, 5/6 weeks after they have had their 5 acupuncture sessions and then 2 months after their last acupuncture session. Patients in the placebo group are offered 5 free sessions of genuine acupuncture once the study is complete.

What are the possible benefits and risks of participating?
For participants who have not had acupuncture before, this can be an exciting experience and an opportunity to try something new that may potentially improve symptoms not responsive to other forms of treatment. The risks are low as acupuncture has been shown to be extremely safe when applied by a qualified practitioner. However there is a small risk of local bruising/irritation to the site where the needles are applied.

Where is the study run from?
1. An acupuncture clinic based in Luton (UK)
2. Psychology department of the University of Bedfordshire (UK)

When is the study starting and how long is it expected to run for?
May 2013 to May 2014

Who is funding the study?
Research Centre for Applied Psychology (UK)

Who is the main contact?
Ashley Bennett
Ashley.bennett@beds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ashley Bennett

ORCID ID

Contact details

Department of Psychology
University of Bedfordshire
Park Square
Luton
LU1 3JU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Traditional chinese medicine (TCM), a solution to medically unexplained symptoms? A double-blind randomised control trial and the role of psychological attachment in TCM's therapeutic outcome

Acronym

N/A

Study hypothesis

Traditional Chinese Acupuncture will show significantly greater reduction in unexplained symptoms when compared to a placebo.

Ethics approval

1. Research Centre for Applied Psychology ethics committee, 31/05/2013
2. University of Bedfordshire Research Ethics Committee, 06/09/2013, ref: UREC13

Study design

Single-centre randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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 symptoms are closely related to somatisation which are a set of any symptoms that have no organic explanation.

Intervention

This two arm trial has a treatment arm, in which participants will be given Traditional Chinese Acupuncture and the placebo arm whereby participants will be given placebo acupuncture using the park sham acupuncture device (or similar).

Intervention type

Phase

Not Applicable

Drug names

Primary outcome measures

1. Bradford somatic inventory (BSI)(Mumford et al., 1991)
2. General Health Questionnaire (GHQ-12)(Goldberg, 1978)
All measures are self-report and are taken at three time points: one at baseline (just before they have their first acupuncture session), 5/6 weeks later post-treatment (immediately after their last acupuncture session) and finally at follow-up, which is 2 months after their last appointment

Secondary outcome measures

1. Client – Therapist attachment (CATS) (Mallinckrodt et al., 1995)
2. General Attachment Questionnaire (Bartholomew & Horowitz, 1991)
All measures are self-report and are taken at three time points: one at baseline (just before they have their first acupuncture session), 5/6 weeks later post-treatment (immediately after their last acupuncture session) and finally at follow-up, which is 2 months after their last appointment

Overall trial start date

01/05/2013

Overall trial end date

01/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who are deemed by independent assessor to have medically unexplained symptoms, between the ages of 18-65

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Those who have had more than 5 treatments of acupuncture in the past 12 months will be excluded.
2. Those with complex and possibly terminal prognoses will be excluded (eg. cancer patients)
3. Anyone who has undergone any major surgery in the preceding 6 months prior to the start of the trial
4. Anyone who has a severe psychiatric diagnosis

Recruitment start date

01/05/2013

Recruitment end date

01/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychology
Luton
LU1 3JU
United Kingdom

Sponsor information

Organisation

University of Bedfordshire

Sponsor details

c/o Ashley Bennett
Department of Psychology
Park Square
Luton
LU1 3JU
United Kingdom

Sponsor type

University/education

Website

http://www.beds.ac.uk/

Funders

Funder type

Research organisation

Funder name

Research Centre for Applied Psychology (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

Publication citations

Additional files

Editorial Notes