全身光生物调节对纤维肌痛患者疼痛、功能、组织质量、中枢敏化和心理因素的短期和长期影响：一项三盲随机临床试验方案

Short- and long-term effects of whole-body photobiomodulation on pain, functionality, tissue quality, central sensitisation and psychological factors in a population suffering from fibromyalgia: protocol for a triple-blinded randomised clinical trial.

作者信息

Navarro-Ledesma Santiago, Gonzalez-Muñoz Ana, Carroll James, Burton Patricia

机构信息

Department of Physiotherapy, Faculty of Health Sciences, Campus of Melilla, University of Granada, Querol Street, 5, 52004 Melilla, Spain.

Clinica Ana Gonzalez, Malaga, Spain.

出版信息

Ther Adv Chronic Dis. 2022 Feb 21;13:20406223221078095. doi: 10.1177/20406223221078095. eCollection 2022.

BACKGROUND

The development of an integral and global treatment to improve the quality of life in those with fibromyalgia syndrome (FMS) is challenging. The aim of this study is to investigate the impact of whole-body photobiomodulation (PBM) on pain perception, functionality, quality of soft tissue, central sensitisation and psychological factors in patients suffering with FMS.

METHODS

This study is a randomised, placebo-controlled clinical trial. A total of 44 participants will be recruited in a private care practice and randomised to receive either a whole-body PBM therapy programme or placebo in the same care centre. The parameters of the PBM programme are as follows: wavelengths of red and near-infrared LEDs 50:50 ratio with 660-850 nanometers; fluence of 25.2 J/cm; treatment time of 1200 s and a total power emitted of 967 W. Treatment sessions will be 3 times weekly for a period of 4 weeks, totalling 12 treatment sessions. Primary outcome will be pain (Numeric Pain Rating Scale; Widespread Pain Index; Symptom Severity Score). Secondary outcomes will be functionality (Fibromyalgia Impact Questionnaire; the Leisure Time Physical Activity Instrument), quality of soft tissue (elastography), central sensitisation (pain pressure threshold and the Autonomic Symptom Profile) and psychological factors (Pain Catastrophising scale, Tampa Scale, Self-Efficacy questionnaire). Assessments will be at baseline (T1), after session 6 (T2), after treatment (T3) and 2 weeks (T4), 3 (T5) and 6 (T6) month follow-up.

DISCUSSION

PBM therapy has been shown to reduce pain and inflammation and to increase the rate of tissue repair for a wide range of conditions, but its potential use as a whole-body treatment in FM is yet to be explored. This trial will investigate whether whole-body PBM therapy is effective at reducing pain intensity, improving functionality, quality of soft tissue, central sensitisation symptoms and psychological measurements. Furthermore, 3- and 6-month follow-up will investigate long-term efficacy of this treatment.

TRIAL REGISTRATION

NCT04248972. Registered on January 29, 2020, https://clinicaltrials.gov/ct2/show/NCT04248972?term=navarro-ledesma+santiago&draw=2&rank=2.

背景

制定一套完整的综合治疗方案以改善纤维肌痛综合征（FMS）患者的生活质量具有挑战性。本研究旨在探讨全身光生物调节（PBM）对FMS患者疼痛感知、功能、软组织质量、中枢敏化和心理因素的影响。

方法

本研究为一项随机、安慰剂对照临床试验。在一家私人护理机构招募44名参与者，并随机分配至同一护理中心接受全身PBM治疗方案或安慰剂治疗。PBM治疗方案的参数如下：红色和近红外发光二极管波长比例为50:50，波长范围为660 - 850纳米；能量密度为25.2 J/cm；治疗时间为1200秒，总发射功率为967瓦。治疗疗程为每周3次，共4周，总计12次治疗。主要结局指标为疼痛（数字疼痛评分量表、广泛性疼痛指数、症状严重程度评分）。次要结局指标为功能（纤维肌痛影响问卷、休闲时间体力活动量表）、软组织质量（弹性成像）、中枢敏化（疼痛压力阈值和自主神经症状量表）和心理因素（疼痛灾难化量表、坦帕量表、自我效能量表）。评估时间点为基线（T1）、第6次治疗后（T2）、治疗结束后（T3）以及2周（T4）、3周（T5）和6个月（T6）随访时。