Effect of opposing needling on motor cortex excitability in healthy participants and in patients with post-stroke hemiplegia: study protocol for a single-blind, randomised controlled trial

Background Opposing needling has an obvious curative effect in the treatment of post-stroke hemiplegia; however, the mechanism of the opposing needling in the treatment of post-stroke hemiplegia is still not clear. The purpose of this study is to investigate the effect of opposing needling on the excitability of primary motor cortex (M1) of healthy participants and patients with post-stroke hemiplegia, which may provide insight into the mechanisms of opposing needling in treating post-stroke hemiplegia. Methods This will be a single-blind, randomised, sham-controlled trial in which 80 healthy participants and 40 patients with post-stroke hemiplegia will be recruited. Healthy participants will be randomised 1:1:1:1 to the 2-Hz, 50-Hz, 100-Hz, and sham electroacupuncture groups. Patients with post-stroke hemiplegia will be randomised 1:1 to the opposing needling or conventional treatment groups. The M1 will be located in all groups by using neuroimaging-based navigation. The stimulator coil of transcranial magnetic stimulation (TMS) will be moved over the left and right M1 in order to identify the TMS hotspot, followed by a recording of resting motor thresholds (RMTs) and motor-evoked potentials (MEPs) of the thenar muscles induced by TMS before and after the intervention. The primary outcome measure will be the percent change in the RMTs of the thenar muscles at baseline and after the intervention. The secondary outcome measures will be the amplitude (μV) and latency (ms) of the MEPs of the thenar muscles at baseline and after the intervention. Discussion The aim of this trial is to explore the effect of opposing needling on the excitability of M1 of healthy participants and patients with post-stroke hemiplegia. Trial registration Chinese Clinical Trial Registry ChiCTR1900028138. Registered on 13 December 2019.

Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: Study protocol for a randomized, sham-controlled clinical trial

Background: Opposing needling is a unique method used in acupuncture therapy to relieve pain, acting on the side contralateral to the pain. Although opposing needling has been used to treat pain in various diseases, it is not clear how opposing needling affects the activity of the central nervous system to relieve acute pain. We herein present the protocol for a randomized sham-controlled clinical trial aiming to explore the cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty (TKA).Methods: This is a randomized sham-controlled single-blind clinical trial. Patients will be allocated randomly to two parallel groups (A: opposing electroacupuncture group; B: sham opposing electroacupuncture group). The YINLINGQUAN (SP9), YANGLINGQUAN (GB34), FUTU (ST32), and ZUSANLI (ST36) acupoints will be used as the opposing needling sites in both groups. In group A, the healthy lower limbs will receive electroacupuncture, while in group B, the healthy lower limbs will receive sham electroacupuncture. At 72 h after unilateral TKA, patients in both groups will begin treatment once per day for 3 days. Functional magnetic resonance imaging will be performed on all patients before the intervention, after unilateral TKA, and at the end of the intervention to detect changes in brain activity. Changes in pressure pain thresholds will be used as the main outcome for the improvement of knee joint pain. Secondary outcome indicators will include the visual analogue scale (including pain during rest and activity) and a 4-m walking test. Surface electromyography, additional analgesia use, the self-rating anxiety scale, and the self-rating depression scale will be used as additional outcome indices.Discussion: The results will reveal the influence of opposing needling on cerebral activity in patients with acute pain after unilateral TKA and the possible relationship between cerebral activity changes and improvement of clinical variables, which may indicate the central mechanism of opposing needling in managing acute pain after unilateral TKA.Trial registration: ChiCTR2100042429, registered on January 21, 2021.

Effect of opposing needling on motor cortex excitability in healthy participants and in patients with post-stroke hemiplegia: Study protocol for a single-blind, randomised controlled trial

Background: Opposing needling has obvious curative effect in the treatment of poststroke hemiplegia, however, the mechanism of the opposing needling in the treatment of poststroke hemiplegia is still not clear. The purpose of this study is to investigate the effect of opposing needling on the excitability of primary motor cortex(M1) of healthy subjects and patients with poststroke hemiplegia, which may provide insight into the mechanisms of opposing needling in treating poststroke hemiplegia.Methods: This will be a single-blind, randomised, sham-controlled trial in which 80 healthy participants and 40 patients with post-stroke hemiplegia will be recruited. Healthy participants will be randomised 1:1:1:1 to the 2-Hz, 50-Hz, 100-Hz, and sham electroacupuncture groups. Patients with post-stroke hemiplegia will be randomised 1:1 to the opposing needling or conventional treatment groups. The M1 will be located in both groups by using neuroimaging-based navigation. The stimulator coil of transcranial magnetic stimulation (TMS) will be moved over the left and right M1 in order to identify the TMS hotspot, followed by recording of motor-evoked potentials (MEPs) and resting motor thresholds (RMTs) of the thenar muscles induced by TMS before and after electroacupuncture or sham electroacupuncture. The primary outcome measure will be the percent change in the RMT of the thenar muscles at baseline and after the intervention. The secondary outcome measures will be the amplitude (μV) and latency (ms) of the MEP of the thenar muscles at baseline and after the intervention.Discussion: The aim of this trial is to explore the effect of opposing needling on the excitability of M1of healthy subjects and patients with poststroke hemiplegia.Trial registration: Chinese Clinical Trial Registry, ChiCTR1900028138, Registered on 13 December 2019.