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

Not Applicable

Completed

• Conditions: Neuralgia; Neuralgia; Postherpetic; Diabetic Neuropathy, Painful; Failed Back Surgery Syndrome
• Interventions: Procedure: Electroacupuncture

• Registration Number: NCT03315598
• Lead Sponsor: Seoul National University

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.

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Primary Completion: 2018-02-23
• Study Completion: 2018-02-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
An open-labeled, single-arm, exploratory pilot study	Electroacupuncture	Electroacupunture for 2months

Primary Outcome Measures

Name	Time	Method
Change from baseline Numeric rating scale pain score (0-10) at 8 weeks	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 (%).
Change from baseline Numeric rating scale pain score (0-10) at 4 weeks	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 (%).

Secondary Outcome Measures

Name	Time	Method
Change from the score of the short-form McGill Pain Questionnaire at 8 weeks	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).
Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks	At 8-week follow-up visit	The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.
5-pointed patient satisfaction scale	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
Patients' Global Impression of Change (PGIC) scale	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of