Randomized Controlled Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Mar 26, 2023; 11(9): 1974-1984
Published online Mar 26, 2023. doi: 10.12998/wjcc.v11.i9.1974
Effects of individual shock wave therapy vs celecoxib on hip pain caused by femoral head necrosis
Jun-Yu Zhu, Jun Yan, Jian Xiao, Hai-Guang Jia, Hao-Jun Liang, Geng-Yan Xing
Jun-Yu Zhu, Geng-Yan Xing, Orthopedic Department, The Third Medical Center of Chinese People’s Liberation Army General Hospital, The Armed Police Clinical College, Anhui Medical University, Hefei 230022, Anhui Province, China
Jun-Yu Zhu, Jun Yan, Jian Xiao, Hai-Guang Jia, Hao-Jun Liang, Orthopedic Department, The Third Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100039, China
Author contributions: Xing GY designed this study; Yan J and Jia HG collected the data; Liang HJ analyzed the data; Zhu JY and Xiao J drafted the manuscript and gave final approval of the version to be published.
Institutional review board statement: The research protocol was approved by the Ethics Committee of The Third Medical Center of Chinese People’s Liberation Army General Hospital (ID: 001-R1).
Clinical trial registration statement: This study was registered on the Chinese Clinical Trial Registry (ChiCTR2100047844).
Informed consent statement: Informed written consent was obtained from the patients to publish this report and any accompanying images.
Conflict-of-interest statement: The authors declare that they have no conflicts of interest.
Data sharing statement: The datasets used and/or analyzed in the current study are available from the corresponding author upon reasonable request.
CONSORT 2010 statement: The manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Geng-Yan Xing, PhD, Additional Professor, Orthopedic Department, The Third Medical Center of Chinese People’s Liberation Army General Hospital, The Armed Police Clinical College, Anhui Medical University, No. 81 Meishan Road, Hefei 230022, Anhui Province, China. jyzhu@ihep.ac.cn
Received: November 19, 2022
Peer-review started: November 19, 2022
First decision: January 30, 2023
Revised: February 7, 2023
Accepted: March 3, 2023
Article in press: March 3, 2023
Published online: March 26, 2023
Abstract
BACKGROUND

Celecoxib has been used to treat hip discomfort and functional difficulties associated with osteonecrosis of the femoral head (ONFH), although significant adverse reactions often follow long-term use. Extracorporeal shock wave therapy (ESWT) can delay the progression of ONFH, alleviate the pain and functional limitations it causes, and avoid the adverse effects of celecoxib.

AIM

To investigate the effects of individual ESWT, a treatment alternative to the use of celecoxib, in alleviating pain and dysfunction caused by ONFH.

METHODS

This was a randomized, controlled, double-blinded, non-inferiority trial. We examined 80 patients for eligibility in this study; 8 patients were excluded based on inclusion and exclusion criteria. A total of 72 subjects with ONFH were randomly assigned to group A (n = 36; celecoxib + alendronate + sham-placebo shock wave) or group B (n = 36; individual focused shock wave [ESWT based on magnetic resonance imaging three-dimensional (MRI-3D) reconstruction] + alendronate). The outcomes were assessed at baseline, at the end of treatment, and at an 8-wk follow-up. The primary outcome measure was treatment efficiency after 2 wk of intervention using the Harris hip score (HHS) (improvement of 10 points or more from the baseline was deemed sufficient). Secondary outcome measures were post-treatment HHS, visual analog scale (VAS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores.

RESULTS

After treatment, the pain treatment efficiency of group B was greater than that of group A (69% vs 51%; 95%CI: 4.56% to 40.56%), with non-inferiority thresholds of -4.56% and -10%, respectively. Furthermore, the HHS, WOMAC, and VAS scores in group B dramatically improved during the follow-up period as compared to those in group A (P < 0.001). After therapy, the VAS and WOMAC in group A were significantly improved from the 2nd to 8th wk (P < 0.001), although HHS was only significantly altered at the 2 wk point (P < 0.001). On the 1st d and 2nd wk after treatment, HHS and VAS scores were different between groups, with the difference in HHS lasting until week 4. Neither group had severe complications such as skin ulcer infection or lower limb motor-sensory disturbance.

CONCLUSION

Individual shock wave therapy (ESWT) based on MRI-3D reconstruction was not inferior to celecoxib in managing hip pain and restrictions associated with ONFH.

Keywords: Extracorporeal shockwave therapy, Osteonecrosis of femoral head, Pain, Magnetic resonance imaging three-dimensional reconstruction, Celecoxib

Core Tip: This is a randomized, controlled, and non-inferiority trial. To the best of our knowledge, the present study is the first to investigate the short-term effectiveness of extracorporeal shock wave therapy (ESWT) in the management of osteonecrosis of the femoral head (ONFH). Traditional ESWT was innovated by magnetic resonance imaging three-dimensional (MRI-3D) reconstruction technology. The final results demonstrate that ESWT based on MRI-3D reconstruction is not inferior to celecoxib in treating hip discomfort and restrictions associated with ONFH.