Clinical trial NCT03315598: Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain
Official title: Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain: An Open-labeled, Single-arm, Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuralgia
Neuralgia; Postherpetic
Diabetic Neuropathy, Painful
Failed Back Surgery Syndrome
Keywords: Neuralgia, Acupuncture Treatment
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Numeric rating scale pain score (0-10) at 4 weeks
timeFrame: At 4-week follow-up visit
measure: Change from baseline Numeric rating scale pain score (0-10) at 8 weeks
timeFrame: At 8-week follow-up visit
Secondary outcomes:
measure: Change from the score of the short-form McGill Pain Questionnaire at 8 weeks
timeFrame: At 8-week follow-up visit
measure: Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks
timeFrame: At 8-week follow-up visit
measure: Patients' Global Impression of Change (PGIC) scale
timeFrame: At 8-week follow-up visit
measure: 5-pointed patient satisfaction scale
timeFrame: At 8-week follow-up visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jee Youn Moon, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee S, Lee CS, Moon JY, Song HG, Yoo Y, Kim J, Seo H, Lee SH. Electroacupuncture May Improve Burning and Electric Shock-Like Neuropathic Pain: A Prospective Exploratory Pilot Study. J Altern Complement Med. 2020 Dec;26(12):1136-1143. doi: 10.1089/acm.2020.0307. Epub 2020 Oct 19.