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
|Condition or disease||Intervention/treatment||Phase|
|Neuralgia Neuralgia; Postherpetic Diabetic Neuropathy, Painful Failed Back Surgery Syndrome||Procedure: Electroacupuncture||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: An open-labeled, single-arm, exploratory pilot study
Electroacupunture for 2months
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.
- 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 (%).
- 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).
- 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.
- 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.
- 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
- Neither satisfied nor dissatisfied
- Very dissatisfied
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
|Contact: Ho-jin Leeemail@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Hyejin Seo, RN firstname.lastname@example.org|
|Contact: Jeeyoun Moon, MD email@example.com|
|Principal Investigator:||Jee Youn Moon, Professor||Seoul National University Hospital|