Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/07/2010
Date assigned
30/07/2010
Last edited
25/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Edward Jude

ORCID ID

Contact details

Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom
Edward.Jude@tgh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5113

Study information

Scientific title

Acronym

DRN196 (Acupuncture in Painful Diabetic Neuropathy)

Study hypothesis

The hypothesis of the study will be that acupuncture treatment will be additional benefit to patients suffering from lower limb painful diabetic neuropathy when compared to a control group.

Ethics approval

MREC approved (ref: 08/H1011/16A)

Study design

Single centre randomised interventional process of care treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Diabetes Research Network; Subtopic: Both; Disease: Neuropathy

Intervention

Acupuncture

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Pain relief

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2008

Overall trial end date

21/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 1 and type 2 diabetes
2. Aged between 18 - 80 years
3. Presence of diabetic neuropathy
4. Painful neuropathy
5. Receiving treatment for PDN
7. Can attend once a week for 10 weeks

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Planned sample size: 60; UK sample size: 60

Participant exclusion criteria

1. Painful neuropathy attributed to other conditions other than diabetes
2. Patients with poor peirpheral circulation
3. Patients with an active foot ulcer
4. Patients who have had previous acupuncture treatment

Recruitment start date

01/06/2008

Recruitment end date

21/05/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom

Sponsor information

Organisation

Tameside Hospital NHS Foundation Trust (UK)

Sponsor details

Tameside General Hospital
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom

Sponsor type

Government

Website

http://www.tamesidehospital.nhs.uk/pages/default.asp

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0706-10595)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24657491

Publication citations

  1. Results

    Garrow AP, Xing M, Vere J, Verrall B, Wang L, Jude EB, Role of acupuncture in the management of diabetic painful neuropathy (DPN): a pilot RCT., Acupunct Med, 2014, 32, 3, 242-249, doi: 10.1136/acupmed-2013-010495.

Additional files

Editorial Notes