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

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

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

Study Overview

• Status: Completed
• Conditions: Neuralgia; Diabetic Neuropathy, Painful; Failed Back Surgery Syndrome; Neuralgia; Postherpetic
• Intervention / Treatment: Procedure: Electroacupuncture

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University
• Investigators: Principal Investigator: Jee Youn Moon, Professor, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2017
• Primary Completion (ACTUAL): February 23, 2018
• Study Completion (ACTUAL): February 23, 2018

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (ACTUAL): October 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Neuralgia, Acupuncture Treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Neuralgia; Diabetic Neuropathies; Neuralgia, Postherpetic; Failed Back Surgery Syndrome
• Other Study ID Numbers: 1703-024-836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No