Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain

Study Overview
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Brief Summary
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The investigators will evaluate the effectiveness and safety of acupuncture treatment in refractory neuropathic pain patients.

Detailed Description
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The purpose of this study was to evaluate the effectiveness of acupuncture treatment in the patients with the following neuropathic pain related syndrome. Postherpetic neuralgia Failed back surgery syndrome Diabetic neuropathy other peripheral neuropathy Patients with refractory neuropathic pain who do not respond to conservative treatment for more than 3 months should be included. Acupuncture treatment is maintained for 2 months in oriental medicine hospital. The effect is evaluated through the numeric rating score and the validated questionnaire.

Official Title
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Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain: An Open-labeled, Single-arm, Exploratory Pilot Study

Conditions
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Neuralgia, Neuralgia; Postherpetic, Diabetic Neuropathy, Painful, Failed Back Surgery Syndrome

Intervention / Treatment
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* Procedure: Electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who can adequately write a reportable questionnaire Patients who have been diagnosed with one of the following neuropathic pain disease (postherpetic neuralgia, failed back surgery syndrome, diabetic neuropathy, other peripheral neuropathy) Patients who failed conservative treatment at Seoul National University Hospital for more than 3 months. Patients with NRS 5 points or more Patients with painDETECT score 19 points or more Exclusion Criteria: Patients with major mental illness Patients with unstable medical conditions Pregnant Patients who received acupuncture treatment at the site within the past month Patients with bleeding tendency Patients taking immunosuppressive drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: An open-labeled, single-arm, exploratory pilot study<br>Electroacupunture for 2months | Procedure: Electroacupuncture<br>* lectroacupuncture is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. According to some acupuncturists, this practice augments the use of regular acupuncture, can restore health and well-being, and is particularly good for treating pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Numeric rating scale pain score (0-10) at 4 weeks | The Numeric Rating Scale (NRS) is an 11-point scale from 0 to 10 for patient self-reporting of pain. Change from the baseline NRS pain score at 4 weeks will be noted as percentage (%). | At 4-week follow-up visit | 
| Change from baseline Numeric rating scale pain score (0-10) at 8 weeks | The Numeric Rating Scale (NRS) is an 11-point scale from 0 to 10 for patient self-reporting of pain. Change from the baseline NRS pain score at 4 weeks will be noted as percentage (%). | At 8-week follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the score of the short-form McGill Pain Questionnaire at 8 weeks | The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The SF-MPQ also includes the Present Pain Intensity (PPI) index of the standard MPQ and a visual analogue scale (VAS). | At 8-week follow-up visit | 
| Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. | At 8-week follow-up visit | 
| Patients' Global Impression of Change (PGIC) scale | The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. | At 8-week follow-up visit | 
| 5-pointed patient satisfaction scale | The 5-pointed patient satisfaction scale is an 5-point scale for patient self-reporting of satisfaction with treatment. Very satisfied Satisfied Neither satisfied nor dissatisfied Dissatisfied Very dissatisfied | At 8-week follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuralgia, Acupuncture Treatment