NMES for the treatment of Diabetic Peripheral Neuropathy
Research type
Research Study
Full title
Neuromuscular Electrical Stimulation for the treatment of Diabetic Peripheral Neuropathy
IRAS ID
149770
Contact name
Alun Davies
Contact email
Sponsor organisation
Imperial College London and Imperial College Healthcare NHS Trust
Duration of Study in the UK
0 years, 6 months, 16 days
Research summary
Research Summary
Up to 50% of diabetic patients will develop a problem with their nerves in the feet. Symptoms can vary from numbness to pain. This increases the risk of ulcers and amputation in diabetic patients.
We are conducting a pilot, prospective, cohort trial to investigate the effect of an electrical device in diabetic patients with nerve problems in their feet. This device causes muscle contraction by stimulating the nerves in the feet and improving blood flow, similar to exercise. Evidence has shown that exercise can improve sensation and symptoms of these diabetic patients. We believe this device can simulate exercise and improve the nerve function in diabetics. We will compare the nerve conduction tests, symptoms and quality of life measures in patients at the start and end of the trial.
This study will gain approval from the Research Ethics Committee and will be conducted in accordance with the recommendations of physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions.
Consent will be obtained from patients following full explanation and time for consideration. Subjects who withdraw from the trial will not be replaced as the drop our rate could potentially give us important information. Baseline data on the patient will be excluded from the analysis.
Participants confidentiality will be maintained during the trial and is registered under the Data Protection Act.
Imperial College London holds negligent harm and non-negligent harm insurance policies which apply to the trial.
The study will be subject to inspection and audit by Imperial College London under their remit as sponsor, the Study Coordination Centre and other regulatory bodies to ensure adherence to GCP.We conducted a study to investigate the potential benefits, safety and practicality of using neuromuscular electrical stimulation (NMES) therapy alongside standard care for people with diabetic neuropathy. Diabetic neuropathy is a condition affecting the nerves in the limbs due to diabetes.
Research Summary
In our study, 25 patients with diabetic neuropathy participated in daily 30-minute NMES therapy sessions using the Revitive® IX device for a period of 10 weeks. Out of these, 20 patients completed the study. Our main focus was to assess nerve conductivity, measured through a nerve conduction study, in specific nerves of the lower limbs. We also looked at outcomes such as blood flow in the leg arteries during NMES therapy compared to rest and changes in the participants' quality of life over the 10-week period.
The results showed significant improvements in nerve function at the end of the 10-week period compared to baseline. Additionally, blood flow in the leg arteries significantly increased during NMES therapy compared to rest, and participants reported a decrease in symptoms related to neuropathy at the end of the 10-week period.
Importantly, the therapy was well-tolerated by the participants, with three unrelated adverse events reported. The majority of participants (15 out of 20) followed the treatment plan.
In conclusion, our study suggests that NMES therapy, when used in addition to standard care, can significantly improve nerve function in the lower limbs of people with diabetic neuropathy. These findings are encouraging and indicate that NMES therapy may offer valuable benefits in the treatment of diabetic neuropathy. However, further research is needed to confirm these results and explore the long-term effects of this therapy.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
14/EM/1302
Date of REC Opinion
10 Dec 2014
REC opinion
Favourable Opinion