None listed
Conditions
Interventions
Medical Device : A study that compares treatment efficacy of electroacupuncture VS. sham electroacupuncture VS. usual care alone in the treatment of painful diabetic neuropathy.
Treatment regimen: 2
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18 to 75 years 2. Diagnosed as Type I or II diabetes mellitus 3. Distal symmetric lower limb pain had been present for at least 6 months 4. At least during four days before randomization, having a score of = 4 on the 11-point pain intensity numerical rating scale (PI-NRS) for pain of diabetic peripheral neuropathy 5. At least 3 on the history and physical exam portion of the Michigan Neuropathy Screening Instrument (MNSI) 6. At least two abnormaility of the following measures - vibration perception by 128Hz tuning fork - 10g monofialment test - Ankle reflexes 7. Stable use (variation of major drug = 25%) had been made in their anti-painful diabetic neuropathic medications within 3 months before screening or no use of anti-painful diabetic neuropathic medications within 1 month. Patients are allowed to take a maximum of 3g of rescue medication (acetaminophen) per day. 8. Agreed with written informed consent
Exclusion criteria
Exclusion criteria: 1. Substance abuse or dependence 2. Cardiovascular disorder (e.g. arrhythmia) or using pascemaker 3. Psychoneurotic scauses : epilepsy, depression, panic disorder 4. At least other symtoms related with diabetes within 3 months 5. HbA1c > 11% 6. Diagnosed as Diabetic Foot Ulcer 7. Other severe pain than painful diabetic neuropathy (e.g. arthritis, back pain) 8. Abnormal level of blood test (HbA1c, Glucose, BUN, Creatinine, TSH, T3, free T4, Vit B12) or urine test (urine protein) 9. Different cause of neuropathic pain other than diabetes (malignant disease, tarsal tunnel syndrome, neurothlipsis, deficiency of Vit B12, hypothyroidism, neurotoxicity (e.g. lead, alcohol, smoking), medication (chemotherapy, isoniazid), transient ischemic attack, stroke, multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, Uremic Neuropathy, subacute combined degeneration of spinal cord, phantom limb pain, artherosclerosis obliterans) 10. Known hypersensitivity reaction after acupuncture treatment or inability to cooperate with acupuncture procedure 11. Used electrical therapy of patch treatment (lidocaine or capsaicin) for painful diabetic neuropathy last 2 weeks 12. Received acupuncture, moxibustion, cupping or herbal medicine for painful diabetic neuropathy last 2 weeks 13. Those who have participated in other clinical trials during the past 3 months 14. Pregnant, expecting pregnant or breast-feeding women 15. Those who are not willing to comply with this study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 11-point pain intensity numerical rating scale (PI-NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Short-Form McGill Pain Questionnaire (SF-MPQ);sleep disturbance score (11-point Likert scale);36 item short form health survey (SF-36);Beck Depression Inventory (BDI);Patient Global Impression of Change (PGIC);Adverse events ;Southampton Needle Sensation Questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactSeunghoon Lee
Korea Institute of Oriental Medicine
Outcome results
None listed