ISRCTN11665378
Active, not recruiting
未知
The utility of frequency-modulated electromagnetic neural stimulation as a third-line treatment in patients with painful diabetes-related peripheral neuropathy: a randomised controlled trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Painful diabetes-related peripheral neuropathy
- Sponsor
- niversity of Birmingham
- Enrollment
- 356
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged \=18 years
- •2\. Neuropathic pain affecting both feet for \=3 months or taking pain medication for neuropathic pain for \=3 months
- •3\. Mean pain score \=4 on the daily NRS for 1 week prior to randomisation
- •4\. Douleur Neuropathique 4 (DN\-4\) questionnaire score \=4/10 at screening to confirm the diagnosis of bilateral distal symmetrical neuropathic pain
- •5\. Diabetes\-related neuropathy based on the Michigan Neuropathy Screening Instrument (MNSI) (MNSI questionnaire scored \=7 or examination scored \>2\)
- •6\. HbA1c \<108 mmol/mol or 12% (within the last 2 months)
- •7\. Have tried at least two drugs from two different classes for PDPN
- •8\. Willing and able to comply with the study schedule and be available for the treatment duration
- •9\. Able to give written informed consent
Exclusion Criteria
- •1\. Non\-diabetic neuropathies
- •2\. Currently using TENS for PDPN
- •3\. History of epilepsy
- •4\. Other painful medical conditions where the pain is significantly more severe than their PDPN pain (patients will not be excluded if the pain is transient in nature)
- •5\. Major amputations of the lower limbs
- •6\. Active diabetic foot ulcers
- •7\. Diagnosed malignancy
- •8\. Pacemakers, defibrillator or neurostimulator
- •9\. Pregnancy
Outcomes
Primary Outcomes
Not specified
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