A randomised controlled trial examining the effectiveness of acupuncture in the treatment of lower limb painful neuropathy in diabetes

ISRCTN ISRCTN39740785
DOI https://doi.org/10.1186/ISRCTN39740785
Secondary identifying numbers 5113
Submission date
30/07/2010
Registration date
30/07/2010
Last edited
25/03/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Edward Jude
Scientific

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

Email Edward.Jude@tgh.nhs.uk

Study information

Study designSingle centre randomised interventional process of care treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymDRN196 (Acupuncture in Painful Diabetic Neuropathy)
Study objectivesThe 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(s)MREC approved (ref: 08/H1011/16A)
Health condition(s) or problem(s) studiedTopic: Diabetes Research Network; Subtopic: Both; Disease: Neuropathy
InterventionAcupuncture
Intervention typeOther
Primary outcome measurePain relief
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2008
Completion date21/05/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participantsPlanned sample size: 60; UK sample size: 60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2008
Date of final enrolment21/05/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Tameside Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

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

Website http://www.tamesidehospital.nhs.uk/pages/default.asp
ROR logo "ROR" https://ror.org/04d713p41

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2014 Yes No