Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain: An Open-labeled, Single-arm, Exploratory Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Seoul National University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Change from baseline Numeric rating scale pain score (0-10) at 8 weeks
Study Overview
Brief Summary
The investigators will evaluate the effectiveness and safety of acupuncture treatment in refractory neuropathic pain patients.
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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Patients who received acupuncture treatment at the site within the past month
- •Patients with bleeding tendency
- •Patients taking immunosuppressive drugs
Arms & Interventions
An open-labeled, single-arm, exploratory pilot study
Electroacupunture for 2months
Intervention: Electroacupuncture (Procedure)
Outcomes
Primary Outcomes
Change from baseline Numeric rating scale pain score (0-10) at 8 weeks
Time Frame: 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 (%).
Change from baseline Numeric rating scale pain score (0-10) at 4 weeks
Time Frame: 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 (%).
Secondary Outcomes
- Change from the score of the short-form McGill Pain Questionnaire at 8 weeks(At 8-week follow-up visit)
- Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks(At 8-week follow-up visit)
- 5-pointed patient satisfaction scale(At 8-week follow-up visit)
- Patients' Global Impression of Change (PGIC) scale(At 8-week follow-up visit)
Investigators
Jeeyoun Moon
Associate professor
Seoul National University