Excerpt from: Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial

Bioelectronic Medicine volume 8, Article number: 12 (2022)
As pharmacological treatments are the primary option for opioid use disorder, neuromodulation has recently demonstrated efficacy in managing opioid withdrawal syndrome (OWS). This study investigated the safety and effectiveness of transcutaneous auricular neurostimulation (tAN) for managing OWS.

Methods:
This prospective inpatient trial included a 30-minute randomized, sham-controlled, double-blind period followed by a 5-day open-label period. Adults with physical dependence on opioids were randomized to receive active or sham tAN following abrupt opioid discontinuation. The Clinical Opiate Withdrawal Scale (COWS) was used to determine withdrawal level, and participants were required to have a baseline COWS score ≥ 13 before enrollment. The double-blind period of the study occurred during the first 30-minutes to assess the acute effects of tAN therapy compared to a sham control. Group 1 received active tAN during both the 30-minute double-blind period and the 5-day open-label period. Group 2 received passive sham tAN (no stimulation) during the double-blind period, followed by active tAN during the 5-day open-label period. The primary outcome was change in COWS from baseline to 60-minutes of active tAN (pooled across groups, accounting for 30-minute delay). Secondary outcomes included difference in change in COWS scores between groups after 30-minutes of active or sham tAN, change in COWS scores after 120-minutes of active tAN, and change in COWS scores on Days 2–5. Non-opioid comfort medications were administered during the trial.

Results
Across all thirty-one participants, the mean (SD) COWS scores relative to baseline were reduced by 7.0 (4.7) points after 60-minutes of active tAN across both groups (p < 0.0001; Cohen’s d = 2.0), demonstrating a significant and clinically meaningful reduction of 45.9%. After 30-minutes of active tAN (Group 1) or sham tAN (Group 2), the active tAN group demonstrated a significantly greater COWS score reduction than the sham tAN group (41.7% vs. 24.1%; p = 0.036). Participants across both groups achieved an average COWS reduction up to 74.7% on Days 2–5.Conclusion
Results demonstrate tAN is a safe and effective non-opioid approach for reducing symptoms of OWS. This study supported an FDA clearance.

https://bioelecmed.biomedcentral.com/articles/10.1186/s42234-022-00095-x

Excerpt From: Journal of Pain & Relief. 2022. 11:7. Effectiveness of Percutaneous Electrical Neurostimulation (Pens) for Post-Operative Pain in Cesarean Section (C-section) 

Dr. Guru Nath S*1,S. Madhuchander2

1Department of Pharmacology, M.Pharm (Pharmacology), PhD, Vaagdevi Institute of Pharmaceutical Sciences, Bollikunta, Warangal, Telangana, India

2Department of General Medicine,MBBS, MD(OBG), FCCP, Jeevak Multispeciality Hospital, Bheemaram, Warangal,Telangana, India

Conclusion:

The auricular PENS device is an effective analgesic adjuvant that 24 hours. The least-square means analysis of the data indicates that the intervention treatment outperforms the standard treatment within the first six hours of the follow up.

The pain score of the intervention group reached zero by the end of the first six hours of the follow-up.

https://www.krystalanesthesia.com/s/Evaluation-of-Percutaneous-Electrical-Nerve-Stimulation-of-the-Auricle-for-Relief-of-Postoperative-P.pdf

Excerpt From: Neuromodulation with percutaneous electricalnerve field stimulation is associated withreduction in signs and symptoms of opioidwithdrawal: a multisite, retrospective assessment

Adrian Miranda & Arturo TacaTo cite this article: Adrian Miranda & Arturo Taca (2018) Neuromodulation with percutaneouselectrical nerve field stimulation is associated with reduction in signs and symptoms of opioid withdrawal: a multisite, retrospective assessment, The American Journal of Drug and Alcohol Abuse, 44:1, 56-63, DOI: 10.1080/00952990.2017.1295459To link to this article:

ABSTRACT: Background: Finding an effective, non-pharmacological approach to treat opioid withdrawal could remove some of the barriers associated with pharmacotherapy. The device is a percutaneous electrical nerve field stimulator developed to target pain. Objectives: This pilot study aimed to determine (1) the effects of the device on withdrawal scores during the induction phase of opioid withdrawal therapy, (2) the percentage of subjects who successfully transitioned to medication assisted therapy (MAT).Methods: Adult patients treated with the the device during medically supervised withdrawal were included in this open label, uncontrolled, and retrospective study. The clinical opioid withdrawal scale (COWS) scores were prospectively recorded at different intervals (20, 30, and 60 min) and analyzed retrospectively. A subset of patients had scores recorded 5-days post-BRIDGE. Those who returned to the clinic and received their first dose of maintenance medication were considered to be successfully transitioned. Results: In this cohort(n=73), 65% were male. The mean COWS score prior to BRIDGE placement was 20.1 (±6.1). Twenty minutes after device placement, the mean score was reduced to 7.5 (±5.9) (62.7% reduction, p<0.001). The scores further decreased after 30 minutes 4.0 (±4.4) and 60 minutes 3.1 (±3.4)(84.6% reduction, p<0.001). No rescue medications were administered during this period. The mean withdrawal score on day 5 was 0.6 (97.1% reduction, p<0.001) (n=33). Overall, 64/73patients (88.8%) successfully transitioned to MAT. Conclusions: Neurostimulation with is associated with a reduction in opioid withdrawal scores. This effect persisted during the induction period and allowed for effective transition to MAT.

https://doi.org/10.1080/00952990.2017.1295459Published online: 16 Mar 2017.Submit your article to this journal

Excerpt From: Case Reports In Anesthesiology. Volume 2022, Article ID 2133998. 5 pages.

https://doi.org/10.1155/2022/2133998

Neurostimulation as an Efficacious Nonpharmacologic Analgesic following Arthroscopic Rotator Cuff Repair

Ryan B. Juncker ,1 Joel J. Gagnier,2 and Faisal M. Mirza3

1Department of Orthopaedic Surgery, David Geffen School of Medicine, University of California, Los Angeles (UCLA),

Los Angeles, CA, USA

2Department of Orthopaedic Surgery, Department of Epidemiology, University of Michigan, Ann Arbor, MI, USA

Published 15 April 2022

Conclusion:

Through the literature presented, it is apparent that a nonpharmacologic alternative to narcotics is needed to fulfill an unmet need of avoiding potential adverse events due to opioids and NSAID use after orthopedic surgery. The auricular electrostimulation device presented may provide one such solution, and further research should be undertaken to move towards clinical use of this or a similar device. 

Despite these potential limitations, the authors believe the use of auricular electrostimulation devices as peri and postoperative nonpharmacologic analgesic warrants further study, and the implementation of clinical trials to confirm the overwhelmingly positive results seen in this case should be undertaken immediately. Ths device also has the potential for massive implications into the future of surgical and nonsurgical pain management. Due to the limited published data on this nonpharmacologic device, it cannot be confirmed with certainty, but it is reasonable to assume that auricular electrostimulation and/or other forms of neurostimulation will be a large part of the future in pain management, theoretically expanding to use in major surgeries and chronic pain treatment.