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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Knee Osteoarthritis | Study protocol

Efficacy of different-frequency TEAS on acute pain after the total knee arthroplasty: a study protocol for a parallel group randomized trial

Authors: Yulin Li, Lixi Chu, Xiangming Li, Weitao Zhai, Yinghui Ma, Yong He, Yuelin Xu, Sheng Ding, Huali Gao, Jing Zhang, Bowen Ye, Jingchao Wang, Jie Yao, Chonggui Wu, Lianbo Xiao

Published in: Trials | Issue 1/2019

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Abstract

Background

Total knee arthroplasty (TKA) is an optimal option for patients with middle-to-end-stage knee osteoarthritis. However, the management of postoperative acute pain remains inefficient. Transcutaneous electrical acupoint stimulation (TEAS) is a nonpharmacological method to manage postoperative acute pain. Different frequencies of TEAS have been tested using varying parameters, but the optimal analgesic frequency remains controversial. The aim of this study was to explore the optimal analgesic frequency of TEAS for treating acute pain after the primary unilateral TKA.

Methods/design

This is a double-blind, randomized controlled trial. A total of 156 patients are randomly assigned to: G1, 5 Hz TEAS; G2, 100 Hz TEAS; G3, mixed TEAS (alternative use of daily 5 Hz and 100 Hz TEAS) and G4, placebo TEAS. In the G1, G2 and G3 groups, TEAS is conducted at acupoints SP9 and GB34 of the leg that was operated on (at a wave of continuous, balanced and asymmetrical biphasic square, with a pulse width of 200 μs, and a strong but comfortable current) for 30 min prior to a 30-min rehabilitation session per day for 2 weeks. In G4 group, TEAS is delivered at a strong but comfortable current for 30 s, then the current is gradually decreased to none over the next 15 s. The primary outcomes are measured before surgery, at baseline (POD 3, before TEAS intervention), week 1 and 2 after TEAS intervention with the Numeric Pain Rating Scale and The American Knee Society Score. The secondary outcomes include: (1) Active range of motion of the knee that was operated on; (2) Surface electromyography of both quadriceps; (3) Modified 30-s sit to stand test; (4) Additional usage of analgesia; and (5) SF-36. The additional outcomes include: (1) Patients’ satisfaction rate; (2) Patient’s expectation rate; and (3) Incidence of analgesia-related side effects. To test the blinding of participants and assessors, they are asked to guess whether the subjects received active or placebo TEAS within 5 min after the latest intervention. The safety and financial cost of TEAS are assessed.

Discussion

Mixed TEAS has more favorable effect on acute pain control than the placebo or 5 Hz or 100 Hz TEAS.

Trial registration

ChiCTR1800016347​. Date of registration was 26 May 2018. Retrospectively registered.
Appendix
Available only for authorised users
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Metadata
Title
Efficacy of different-frequency TEAS on acute pain after the total knee arthroplasty: a study protocol for a parallel group randomized trial
Authors
Yulin Li
Lixi Chu
Xiangming Li
Weitao Zhai
Yinghui Ma
Yong He
Yuelin Xu
Sheng Ding
Huali Gao
Jing Zhang
Bowen Ye
Jingchao Wang
Jie Yao
Chonggui Wu
Lianbo Xiao
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3379-3

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