Effectiveness and safety of the electroacupuncture for intractable neuropathic pai
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0003615
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
1. Patients aged 19 years and over at screening
2. Patients who could voluntarily consent to the study, understand the process of the study, and adequately write a reportable questionnaire.
3. Patients who have peripheral neuropathic pain satisfied A and B, and identified C or D depending on the conditions.
A. Having a confirmed medical history according to clinical findings (e.g., postherpetic neuralgia, chemotherapy induced peripheral neuropathy).
B. Symptoms, history, and physical examination of patients are appropriate for peripheral neuropathic pain
C. electromyography (EMG)/nerve conduction study (NCS) or evoked potential test is appropriate for peripheral neuropathy.
D. Ultrasonographic examination at the screening revealed lesions that are appropriate for peripheral entrapment syndrome or peripheral neuropathy
4. Unsatisfactory pain relief despite of appropriate conservative treatment for more than 3 months before screening
5. A score = 13 on the Korean version of the painDETECT Qusestionnaire (PD-Q) at screening
6. An average socre = 4 on the Numeral Rating Scale measured by pain diary during the one-week screening period before randomization.
7. No evidence of disease (NED) recurrence in cancer survivors
1. Other severe pain not related to the target disease induce confusion in pain assessment at screening or randomization.
2.Use of a prohibited concomitant therapy within 7 days prior to screening or a changed concomitant medication with restricted usage change within 14 days prior to screening.
3. Clinically significant unstable nervous system, ophthalmology, hepatobiliary, respiratory, blood disease, cardiovascular disease, or mental disease within 12 months before screening.
4. Use of electrocaupuncture treatment at the affected area within 1 month before screening.
5. Pregnant, breastfeeding, or expecting a pregnancy during the study period.
6. Implanted medical devices such as spinal cord stimulators, implantable drug delivery systems, pacemakers, automatic defibrillators, aneurysm clips, vena cava clips, and skull plates.
7. Brain damage, symptomatic brain metastases, or epilepsy.
8. Abnormal skin conditions that would prevent proper application of the EA treatment.
9. Participation in other interventional clinical trials within 30 days before screening or present.
10. Severe bleeding tendency: low doses of oral aspirin and a general dose of antiplatelet/anticoagulant medication generally do not limit study participation, but only when apparent risk is predicted by the investigator's judgment.
11. Using immunosuppressive drugs such as steroids.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Poportion on the Composite efficacy outcome (CEO) [NRS decreased from baseline + BPI-SF pain interference scale decreased by 20% from baseline + ‘slightly improved’, ‘moderately improved’, or ‘very improved’ in PGIC]
- Secondary Outcome Measures
Name Time Method Difference and proportion on NRS;Difference on the short-form McGill Pain Questionnaire (SF-MPQ);Difference on the Brief Pain Inventory-short form (BPI-SF);Patient global impression change (PGIC);EQ-5D-3L;PainDETECT Questionnaire (PD-Q);Difference on the Fatigue severity scale (FSS);patient satisfaction scale;incremental cost-effective ratio (ICER)