NeuralgiaNCT03315598
Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain
A study testing Electroacupuncture in people with Neuralgia and Neuralgia; Postherpetic, run by Seoul National University at 1 site in South Korea.
Trial summary
The investigators will evaluate the effectiveness and safety of acupuncture treatment in refractory neuropathic pain patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuralgia, Neuralgia; Postherpetic, Diabetic Neuropathy, Painful
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2017to 23 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Neuralgia, Neuralgia; Postherpetic, Diabetic Neuropathy, Painful, Failed Back Surgery Syndrome
- Being tested
- Electroacupuncture
- Keywords
- Neuralgia, Acupuncture Treatment
- Medical subject headings
- Neuralgia, Neuralgia, Postherpetic, Diabetic Neuropathies, Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| An open-labeled, single-arm, exploratory pilot study | Experimental | Electroacupunture for 2months Receives: Procedure: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 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 (%).
Measured: At 8-week follow-up visit
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: At 8-week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start15 May 2017
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Jee Youn Moon, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315598
- Sponsor's protocol ID
- 1703-024-836
- Status last verified
- Sep 2022
- First submitted
- 12 Oct 2017
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03315598
- Acronym / sponsor ID
- 1703-024-836
- Conditions
- Neuralgia, Neuralgia; Postherpetic, Diabetic Neuropathy, Painful, Failed Back Surgery Syndrome
- Keywords
- Neuralgia, Acupuncture Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| An open-labeled, single-arm, exploratory pilot study | Experimental | Procedure: ElectroacupunctureElectroacupunture for 2months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroacupuncturelectroacupuncture 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. | Procedure or surgery | An open-labeled, single-arm, exploratory pilot study |
Primary outcome
Change from baseline Numeric rating scale pain score (0-10) at 4 weeks
Time frame: At 4-week follow-up visit
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
Time frame: At 8-week follow-up visit
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 (%).
4 secondary outcomes
Change from the score of the short-form McGill Pain Questionnaire at 8 weeks
Time frame: At 8-week follow-up visit
Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks
Time frame: At 8-week follow-up visit
Patients' Global Impression of Change (PGIC) scale
Time frame: At 8-week follow-up visit
5-pointed patient satisfaction scale
Time frame: At 8-week follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Derived from this study: PubMed 33074703Lee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jee Youn Moon, Professor principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Neuralgia and Neuralgia; Postherpetic, run by Seoul National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Numeric rating scale pain score (0-10) at 4 weeks (time frame: At 4-week follow-up visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.