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
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
-
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.