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 |
| Protocol serial number | 5113 |
| Sponsor | Tameside Hospital NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0706-10595) |
- 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
Scientific
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom
| Edward.Jude@tgh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised interventional process of care treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | DRN196 (Acupuncture in Painful Diabetic Neuropathy) |
| Study objectives | 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(s) | MREC approved (ref: 08/H1011/16A) |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network; Subtopic: Both; Disease: Neuropathy |
| Intervention | Acupuncture |
| Intervention type | Other |
| Primary outcome measure(s) |
Pain relief |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 21/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 21/05/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom
OL6 9RW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
