Back to resultsEvaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain
Primary Purpose
Neuralgia, Neuralgia; Postherpetic, Diabetic Neuropathy, Painful
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electroacupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia focused on measuring Neuralgia, Acupuncture Treatment
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
An open-labeled, single-arm, exploratory pilot study
Arm Description
Electroacupunture for 2months
Outcomes
Primary Outcome Measures
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 (%).
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 (%).
Secondary Outcome Measures
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).
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.
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.
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
Full Information
NCT ID
NCT03315598
First Posted
October 12, 2017
Last Updated
September 12, 2022
Sponsor
Seoul National University
1. Study Identification
Unique Protocol Identification Number
NCT03315598
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
February 23, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Neuralgia; Postherpetic, Diabetic Neuropathy, Painful, Failed Back Surgery Syndrome
Keywords
Neuralgia, Acupuncture Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
An open-labeled, single-arm, exploratory pilot study
Arm Type
Experimental
Arm Description
Electroacupunture for 2months
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Numeric rating scale pain score (0-10) at 4 weeks
Description
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
Title
Change from baseline Numeric rating scale pain score (0-10) at 8 weeks
Description
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 Outcome Measure Information:
Title
Change from the score of the short-form McGill Pain Questionnaire at 8 weeks
Description
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
Title
Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks
Description
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
Time Frame
At 8-week follow-up visit
Title
Patients' Global Impression of Change (PGIC) scale
Description
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
Title
5-pointed patient satisfaction scale
Description
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
Time Frame
At 8-week follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jee Youn Moon, Professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33074703
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.
Results Reference
derived
Learn more about this trial
Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain
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