The utility of frequency-modulated electromagnetic neural stimulation as a third-line treatment in patients with painful diabetes-related peripheral neuropathy
- Conditions
- Painful diabetes-related peripheral neuropathyNervous System Diseases
- Registration Number
- ISRCTN11665378
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 356
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 7-day average 24-hour pain measured on an 11-point NRS scale (0 = no pain and 10 = worst pain imaginable) at 3 months post-randomisation
- Secondary Outcome Measures
Name Time Method