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NCT Number: NCT03315598

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

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

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Key information

Conditions

Neuralgia Back Pain Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Neuropathy, Painful Endocrine System Diseases Failed Back Surgery Syndrome Nervous System Diseases Neuralgia, Postherpetic Neuralgia; Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroacupuncture

Procedure

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 outcomes

  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 outcomes

  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.

    • Very satisfied
    • Satisfied
    • Neither satisfied nor dissatisfied
    • Dissatisfied
    • Very dissatisfied

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2017
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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