Electroacupuncture for Treating Painful Diabetic Neuropathy: A multi-center, randomized, assessor-blinded, controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001135

Enrollment

126

Registered

2014-06-16

Start date

2014-06-10

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : A study that compares treatment efficacy of electroacupuncture VS. control group in the treatment of painful diabetic neuropathy. Treatment regimen: 2 times/week for 8 weeks.

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 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 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 medication, 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. Cardiovascular disorder (e.g. arrhythmia) or using pascemaker 8. Known hypersensitivity reaction after acupuncture treatment or inability to cooperate with acupuncture procedure 9. Pregnant, expecting pregnant or breast-feeding women 10. 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) ;50% Pain reduction	—

Secondary

Measure	Time frame
Short-Form McGill Pain Questionnaire (SF-MPQ) ;sleep disturbance score (11-point Likert scale) ;Nerve Conduction Velocity (Sural nerve);EuroQol-5 dimension (EQ-5D);Rescue medication ;Patient Global Impression of Change (PGIC) ;Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactKyungmin Shin

Korea Institute of Oriental Medicine

kyungmin7221@kiom.re.kr+82-42-223-4051

Outcome results