Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain
Study Details
Study Description
Brief Summary
The investigators will evaluate the effectiveness and safety of acupuncture treatment in refractory neuropathic pain patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study was to evaluate the effectiveness of acupuncture treatment in the patients with the following neuropathic pain related syndrome.
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Postherpetic neuralgia
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Failed back surgery syndrome
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Diabetic neuropathy
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: An open-labeled, single-arm, exploratory pilot study Electroacupunture for 2months |
Procedure: Electroacupuncture
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.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline Numeric rating scale pain score (0-10) at 4 weeks [At 4-week follow-up visit]
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 (%).
- Change from baseline Numeric rating scale pain score (0-10) at 8 weeks [At 8-week follow-up visit]
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 (%).
Secondary Outcome Measures
- Change from the score of the short-form McGill Pain Questionnaire at 8 weeks [At 8-week follow-up visit]
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).
- Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks [At 8-week follow-up visit]
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
- Patients' Global Impression of Change (PGIC) scale [At 8-week follow-up visit]
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.
- 5-pointed patient satisfaction scale [At 8-week follow-up visit]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who can adequately write a reportable questionnaire
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Patients who have been diagnosed with one of the following neuropathic pain disease (postherpetic neuralgia, failed back surgery syndrome, diabetic neuropathy, other peripheral neuropathy)
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Patients who failed conservative treatment at Seoul National University Hospital for more than 3 months.
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Patients with NRS 5 points or more
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Patients with painDETECT score 19 points or more
Exclusion Criteria:
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Patients with major mental illness
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Patients with unstable medical conditions
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Pregnant
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Patients who received acupuncture treatment at the site within the past month
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Patients with bleeding tendency
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Patients taking immunosuppressive drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University
Investigators
- Principal Investigator: Jee Youn Moon, Professor, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1703-024-836