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

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ClinicalTrials.gov Identifier: NCT03315598
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Jeeyoun Moon, Seoul National University

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

Condition or disease Intervention/treatment Phase
Neuralgia Neuralgia; Postherpetic Diabetic Neuropathy, Painful Failed Back Surgery Syndrome Procedure: Electroacupuncture Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2019

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.




Primary Outcome Measures :
  1. 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 (%).

  2. 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 (%).


Secondary Outcome Measures :
  1. Change from the score of the short-form McGill Pain Questionnaire at 8 weeks [ Time Frame: At 8-week follow-up visit ]
    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).

  2. Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks [ Time Frame: At 8-week follow-up visit ]
    The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.

  3. Patients' Global Impression of Change (PGIC) scale [ Time Frame: At 8-week follow-up visit ]

    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.


  4. 5-pointed patient satisfaction scale [ Time Frame: At 8-week follow-up visit ]

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315598


Contacts
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Contact: Ho-jin Lee 82-10-4934-8404 zenerdiode03@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyejin Seo, RN       likeastar_hj@naver.com   
Contact: Jeeyoun Moon, MD       jymoon0901@gmail.com   
Sponsors and Collaborators
Seoul National University
Investigators
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Principal Investigator: Jee Youn Moon, Professor Seoul National University Hospital

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Responsible Party: Jeeyoun Moon, Associate professor, Seoul National University
ClinicalTrials.gov Identifier: NCT03315598     History of Changes
Other Study ID Numbers: 1703-024-836
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeeyoun Moon, Seoul National University:
Neuralgia, Acupuncture Treatment
Additional relevant MeSH terms:
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Neuralgia
Diabetic Neuropathies
Neuralgia, Postherpetic
Failed Back Surgery Syndrome
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Postoperative Complications
Pathologic Processes
Back Pain