Electrical Stimulation in Diabetic Peripheral Neuropathy
NCT ID: NCT02082145
Last Updated: 2020-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2014-07-31
2015-12-31
Brief Summary
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Detailed Description
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Peripheral neuropathy is a dysfunction of the nerves most commonly affecting the arms and legs. Diabetes is the leading cause of neuropathy in the Western world, and diabetic neuropathy is estimated to affect between 20-50% of diabetic people. The American Diabetes Association define it as the 'presence of symptoms and signs of peripheral nerve dysfunction in patients with diabetes after exclusion of other causes'. As regards complications of diabetes, peripheral neuropathy has the greatest detrimental effect on quality of life. Diabetic neuropathy is implicated in 50-75% of non-traumatic amputations.
The device to be tested mimics the effect of walking by stimulating the motor nerves of the leg, making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. We have seen previous clinical cases of improvement in peripheral neuropathy with use of the device, and wish to formalise the benefits to patients. It is hypothesised to work either by increasing blood flow to the limb and therefore the nerves themselves, or for electrical current to be having a direct effect on the peripheral nervous system itself. The device is easily fitted, can be self-administered by patients, and is suitable for out-patient therapy.
We wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic peripheral neuropathy as a therapeutic intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Treated according to local protocol for diabetic peripheral neuropathy
No interventions assigned to this group
NMES
Treated with neuromuscular stimulation of both legs, for 10 weeks
NMES
Application of NMES device bilaterally, once a day, 5 times a week, for 10 weeks
Interventions
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NMES
Application of NMES device bilaterally, once a day, 5 times a week, for 10 weeks
Eligibility Criteria
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Inclusion Criteria
* Diabetes as defined by WHO diagnostic criteria on best medical therapy
* Diabetic peripheral polyneuropathy present, confirmed by nerve conduction testing
Exclusion Criteria
* Pacemaker
* Metal implants in the legs (below knee)
18 Years
ALL
No
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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A H Davies
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Academic Vascular Surgery, Charing Cross Hospital
London, , United Kingdom
Countries
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References
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Kluding PM, Pasnoor M, Singh R, Jernigan S, Farmer K, Rucker J, Sharma NK, Wright DE. The effect of exercise on neuropathic symptoms, nerve function, and cutaneous innervation in people with diabetic peripheral neuropathy. J Diabetes Complications. 2012 Sep-Oct;26(5):424-9. doi: 10.1016/j.jdiacomp.2012.05.007. Epub 2012 Jun 18.
Balducci S, Iacobellis G, Parisi L, Di Biase N, Calandriello E, Leonetti F, Fallucca F. Exercise training can modify the natural history of diabetic peripheral neuropathy. J Diabetes Complications. 2006 Jul-Aug;20(4):216-23. doi: 10.1016/j.jdiacomp.2005.07.005.
Other Identifiers
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13HH1825
Identifier Type: OTHER
Identifier Source: secondary_id
13/LO/1844
Identifier Type: -
Identifier Source: org_study_id