None listed
Conditions
Interventions
Medical Device : Cupping therapy was given twice a week for 8 weeks, for a total of 16 sessions.
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 19 years 2. Diagnosed as Type II diabetes mellitus 3. Distal symmetric lower limb pain had been present for at least 1 month 4. Average Numeric rating scale (NRS) of 4 or higher in a week prior to the screening visit 5. At least 2 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. Agreed with written informed consent
Exclusion criteria
Exclusion criteria: 1. HbA1c > 10% 2. Diagnosed as Diabetic Foot Ulcer 3. 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) 4. Other severe pain than painful diabetic neuropathy (e.g. arthritis, back pain, stenosis, Herniated intervertebral disc(HIVD)) 5. Received electrical therapy, patch treatment (lidocaine or capsaicin), acupuncture, moxibustion, cupping or herbal medicine for painful diabetic neuropathy last 2 weeks 6. Psychoneurotic causes: epilepsy, depression, panic disorder 7. Known hypersensitivity reaction after cupping treatment or inability to cooperate with cupping procedure 8. Pregnant, expecting pregnant or breast-feeding women 9. Those who are not willing to comply with this study protocol 10. Others who have been deemed ineligible by the study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 11-point pain intensity numerical rating scale (PI-NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| sleep disturbance score (11-point Likert scale) ;Short-Form McGill Pain Questionnaire (SF-MPQ) ;EuroQol-5 dimension (EQ-5D) ;Nerve Conduction Velocity (Sural nerve) ;Patient Global Impression of Change (PGIC) ;Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactJunghyo Cho
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed