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CompletedNCT03315598Updated Sep 14, 2022

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

An interventional study of Electroacupuncture in Neuralgia, Neuralgia; Postherpetic and Diabetic Neuropathy, Painful, sponsored by Seoul National University. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-14.

Sponsored by Seoul National University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2017, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 37 studies in Neuralgia with a site in Korea, Republic of — 1 open to participants now, 1 under way, none of them phase 3. Neuralgia · Korea, Republic of.

Enrollment
30th of 34
22 · median 90
Started
2017
with 4 others
No phase
10 of 37
1 open now
Registered
20th of 37
by date
Lead sponsor
3 of 37
Seoul National University

Among the 37 studies in Neuralgia with a site in Korea, Republic of, this one is the 30th largest by enrollment of the 34 interventional ones that give a count, is one of 5 that started in 2017, is one of 10 with no phase, and was the 20th registered.

Neuralgia

1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.

This study's enrollment of 22 is below the median of 52 across 831 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Open to participants now

1 of the 37 studies in Neuralgia with a site in Korea, Republic of is open now.

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 152 Neuralgia studies recruiting now, 76 (50%) set no upper age limit and 44 (29%) stop at 75 or younger; 8 take children under 18; 12 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 37 studies in Neuralgia with a site in Korea, Republic of, or all of them as a file.
02

Study summary

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

Read the 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.

03

Conditions studied

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

Keywords

  • Neuralgia, Acupuncture Treatment
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 drugs
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    An open-labeled, single-arm, exploratory pilot study

    Electroacupunture for 2months

    Procedure: Electroacupuncture

Interventions

  • ProcedureElectroacupuncture

    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.

06

What researchers measure

Primary outcomes

  1. 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 (%).

    Time frame: At 4-week follow-up visit

  2. 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 (%).

    Time frame: At 8-week follow-up visit

Secondary outcomes

  1. 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).

    Time frame: At 8-week follow-up visit

  2. 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.

    Time frame: At 8-week follow-up visit

  3. 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.

    Time frame: At 8-week follow-up visit

  4. 5-pointed patient satisfaction scale

    The 5-pointed patient satisfaction scale is an 5-point scale for patient self-reporting of satisfaction with treatment. 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied

    Time frame: At 8-week follow-up visit

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

References and documents

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. PubMed 33074703 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2017 to primary completion in Feb 2018, 9 months.

Of 246 non-industry interventional studies with no phase under Neuralgia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's 9 months is below that.

Counting every sponsor, half of 264 studies reached it within 24 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2017
First posted
Oct 20, 2017
StartActual
May 15, 2017
Primary completionActual
Feb 23, 2018
CompletionActual
Feb 23, 2018
Last update
Sep 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03315598
Lead sponsor
Seoul National University
Responsible party
Jeeyoun Moon (Associate professor, Seoul National University) — Principal investigator
First posted
Oct 20, 2017
Start date
May 15, 2017
Primary completion
Feb 23, 2018
Completion
Feb 23, 2018
Last update
Sep 14, 2022

Study contacts

Jee Youn Moon, Professor
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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