NCT03315598

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2018

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

October 12, 2017

Last Update Submit

September 12, 2022

Conditions

NeuralgiaNeuralgia; PostherpeticDiabetic Neuropathy, PainfulFailed Back Surgery Syndrome

Keywords

Neuralgia, Acupuncture Treatment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

  • Patients' Global Impression of Change (PGIC) scale

    At 8-week follow-up visit

  • 5-pointed patient satisfaction scale

    At 8-week follow-up visit

Study Arms (1)

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

EXPERIMENTAL

Electroacupunture for 2months

Procedure: Electroacupuncture

Interventions

ElectroacupuncturePROCEDURE

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33074703DERIVED

MeSH Terms

Conditions

NeuralgiaNeuralgia, PostherpeticDiabetic NeuropathiesFailed Back Surgery Syndrome

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesPostoperative ComplicationsPathologic ProcessesBack Pain

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Jee Youn Moon, Professor

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 20, 2017

Study Start

May 15, 2017

Primary Completion

February 23, 2018

Study Completion

February 23, 2018

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

KR(1)