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

Abstract

BackgroundThe 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/designThis 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.DiscussionThe result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN.Trial registrationClinical Research information Service. Unique identifier: KCT0000466.

Acupuncture for the Treatment of Peripheral Neuropathy: A Systematic Review and Meta-Analysis

“…Initial searches identified studies with a focus on acupuncture for the treatment of DPN, chemotherapy-induced neuropathy, HIV-related neuropathy, idiopathic neuropathy, zoster neuralgia, traumatic peroneal neuropathy, and various cranial neuropathies such as Bell's palsy and trigeminal neuralgia. Of the 46 studies that underwent full review, 15 were excluded because they were not RCTs [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] : three for an improper control condition, including verum acupuncture [38][39][40] ; three because they did not focus on acupuncture/involved multiple interventions [41][42][43] ; one 44 because it was identified as a duplicate to an included paper 45 ; one because it was descriptive only 46 ; and eight because of a low SAS-QI CAM score (<10). [47][48][49][50][51][52][53][54] Following a detailed review, 15 papers met the final inclusion criteria (Table 1): 13 RCTs, a 13-month follow-up 55 of an original RCT, 56 and a re-analysis 57 of a previously published paper.…”

Modern acupuncture-like stimulation methods: a literature review

“…As shown in Table 2 , presenting the studies reporting the effect on pain relief, 15 articles reported using TEASs, 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 EAs were used in 18 studies, 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 other acupoint stimulations such as US were used in one study, 77 and LS was used in eight studies. 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 TEASs and EAs were compared in a total of 872 individuals to evaluate their effect on pain relief.…”

Multimodal cerebral imaging study on the effects of “Adjust Zang Dredge Meridian” electroacupuncture on cerebral central sensitization in PDPN patients: a study protocol for a sham-controlled, randomized trial

“…No two-arm, randomized, sham-controlled trial has been conducted on this topic. For this reason, we are using our previous clinical experience to calculate the efficacy of electroacupuncture as an intervention [ 30 , 31 ]. The proposed sample size of this trial was calculated mainly based on the Short-Form McGill Pain Questionnaire and the assumption that after treatment, the average change reported using this questionnaire would be greater for the experimental group than for the control group.…”