Tags

Type your tag names separated by a space and hit enter

Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial.

Abstract

BACKGROUND

The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research.

METHODS/DESIGN

This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit.

DISCUSSION

The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN.

TRIAL REGISTRATION

Clinical Research information Service. Unique identifier: KCT0000466.

Links

  • PMC Free PDF
  • PMC Free Full Text
  • FREE Publisher Full Text
  • Authors+Show Affiliations

    ,

    Acupuncture, Moxibustion & Meridian Research Group, Korea Institute of Oriental Medicine, Daejeon, Korea.

    , , , , , , , , , , ,

    Source

    Trials 14: 2013 Jul 18 pg 225

    MeSH

    Adolescent
    Adult
    Aged
    Clinical Protocols
    Diabetic Neuropathies
    Electroacupuncture
    Female
    Humans
    Male
    Middle Aged
    Pain Measurement
    Pilot Projects
    Predictive Value of Tests
    Republic of Korea
    Research Design
    Surveys and Questionnaires
    Time Factors
    Treatment Outcome
    Young Adult

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    23866906

    Citation

    Lee, Seunghoon, et al. "Electroacupuncture to Treat Painful Diabetic Neuropathy: Study Protocol for a Three-armed, Randomized, Controlled Pilot Trial." Trials, vol. 14, 2013, p. 225.
    Lee S, Kim JH, Shin KM, et al. Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial. Trials. 2013;14:225.
    Lee, S., Kim, J. H., Shin, K. M., Kim, J. E., Kim, T. H., Kang, K. W., ... Choi, S. M. (2013). Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial. Trials, 14, p. 225. doi:10.1186/1745-6215-14-225.
    Lee S, et al. Electroacupuncture to Treat Painful Diabetic Neuropathy: Study Protocol for a Three-armed, Randomized, Controlled Pilot Trial. Trials. 2013 Jul 18;14:225. PubMed PMID: 23866906.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial. AU - Lee,Seunghoon, AU - Kim,Joo-Hee, AU - Shin,Kyung-Min, AU - Kim,Jung-Eun, AU - Kim,Tae-Hun, AU - Kang,Kyung-Won, AU - Lee,Minhee, AU - Jung,So-Young, AU - Shin,Mi-Suk, AU - Kim,Ae-Ran, AU - Park,Hyo-Ju, AU - Hong,Kwon-Eui, AU - Choi,Sun-Mi, Y1 - 2013/07/18/ PY - 2013/02/19/received PY - 2013/07/04/accepted PY - 2013/7/23/entrez PY - 2013/7/23/pubmed PY - 2013/10/18/medline SP - 225 EP - 225 JF - Trials JO - Trials VL - 14 N2 - BACKGROUND: The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. METHODS/DESIGN: This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit. DISCUSSION: The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN. TRIAL REGISTRATION: Clinical Research information Service. Unique identifier: KCT0000466. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/23866906/Electroacupuncture_to_treat_painful_diabetic_neuropathy:_study_protocol_for_a_three_armed_randomized_controlled_pilot_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-225 DB - PRIME DP - Unbound Medicine ER -