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光生物调节疗法治疗肥胖患者减重术前康复期慢性膝关节疼痛的随机、安慰剂对照、双盲、临床试验方案。

Photobiomodulation therapy for chronic knee pain in obese patients in pre-rehabilitation for bariatric surgery: randomised, placebo-controlled, double-blinded, clinical trial protocol.

机构信息

Biophotonics-Medicine Postgraduate Program, Universidade Nove de Julho, Sao Paulo, Brazil.

Universidade Federal de Goias, Goiania, GO, Brazil.

出版信息

BMJ Open. 2024 Jul 1;14(6):e079864. doi: 10.1136/bmjopen-2023-079864.


DOI:10.1136/bmjopen-2023-079864
PMID:38951012
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11328612/
Abstract

INTRODUCTION: Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery. METHODS AND ANALYSES: This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways. ETHICS AND DISSEMINATION: This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH-Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Clinical Trials Platform (https://clinicaltrials.gov/) with the number NCT05816798.

摘要

简介:肥胖已成为全球性的公共卫生问题,与生活质量下降、并发症和合并症直接相关。其中之一是慢性疼痛,尤其是膝盖疼痛,随着体重的增加而显著且成比例地增加。在需要进行减重手术的严重肥胖症患者中,慢性疼痛的存在会使他们无法参加术前康复计划,而且常常阻止他们参加术前康复计划。作为一种镇痛疗法,光生物调节(PBM)已被研究证明具有安全性、有效性、良好耐受性和低成本。因此,本研究旨在评估 PBM 治疗接受减重手术术前康复计划的肥胖患者慢性膝关节疼痛的应用。

方法和分析:这是一项双盲、随机、安慰剂对照的临床优效性试验方案。PBM 将应用于双侧膝关节和腰椎旁脊柱点水平,以对应膝关节神经支配的根。评估的结果将包括疼痛强度、功能、生活质量以及慢性膝关节疼痛途径的神经敏化的临床体征。

伦理和传播:该方案已获得巴西联邦大学戈亚斯州临床医院研究伦理委员会/EBSERH-伦理委员会的批准,并遵循 SPIRIT 指南。结果将进行统计学分析,并随后发表在同行评议的期刊上。

试验注册号:ClinicalTrials.gov(https://clinicaltrials.gov/),编号为 NCT05816798。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d84b/11328612/0baf67346cf2/bmjopen-14-6-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d84b/11328612/784ef385ef0c/bmjopen-14-6-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d84b/11328612/0baf67346cf2/bmjopen-14-6-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d84b/11328612/784ef385ef0c/bmjopen-14-6-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d84b/11328612/0baf67346cf2/bmjopen-14-6-g002.jpg

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本文引用的文献

[1]
Effect of low-level laser therapy plus exercise therapy on pain, range of motion, muscle strength, and function in knee osteoarthritis - a systematic review and meta-analysis.

Somatosens Mot Res. 2023-3

[2]
Effect of Neuromuscular Electrical Stimulation During Walking on Pain Sensitivity in Women With Obesity With Knee Pain: A Randomized Controlled Trial.

Arch Phys Med Rehabil. 2022-9

[3]
Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis.

Physiotherapy. 2022-3

[4]
Chronic pain: an update on burden, best practices, and new advances.

Lancet. 2021-5-29

[5]
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J Pain. 2021-7

[6]
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PLoS Med. 2020-7-28

[8]
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J Clin Med. 2020-6-3

[9]
Obesity and pain: a systematic review.

Int J Obes (Lond). 2020-5

[10]
Effects of bariatric surgery on knee osteoarthritis, knee pain and quality of life in female patients.

J Musculoskelet Neuronal Interact. 2019-12-1

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