Exercise and Rehabilitation Sciences Institute, School of Physical Therapy, Faculty of Rehabilitation Sciences, Universidad Andres Bello, Santiago, 7591538, Chile.
Department of Physical Therapy, Federal University of São Carlos (UFSCar), Rodovia Washington Luis, km 235, São Carlos, São Paulo, Brazil.
Trials. 2023 Aug 31;24(1):563. doi: 10.1186/s13063-023-07599-0.
Chronic non-specific neck pain (CNNP) is a prevalent musculoskeletal disorder known for its significant disability and economic burden, ranking second only to low back pain in musculoskeletal conditions. Physical therapy offers effective interventions for CNNP, including low-level laser therapy (LLLT). High-intensity laser therapy (HILT) is a recent treatment for musculoskeletal pain, but studies that support its use in CNNP are limited. The objective of this study is to assess the effect of high-intensity laser therapy on pain intensity in patients with CNNP, given the existing evidence on LLLT for this condition.
This is a 2-arm, randomized, placebo-controlled trial with blinded evaluators. The research will be carried out in the laboratory of physical agents at the Andrés Bello University, Campus Casona de las Condes. Eligible participants include the entire internal and external community associated with Andrés Bello University suffering from chronic non-specific NP. Participants will be stratified by sex (4 subgroups) and randomized into 2 study groups: group 1 (HILT and stretching exercises) and group 2 (sham HILT and stretching exercises). Treatments will be performed twice a week for 4 weeks with 3 assessments: before treatment (T0), at the end of treatment (T1), and 12 weeks after treatment (follow-up) (T2). The main outcomes will be pain intensity at rest, pain intensity at movement (active cervical movements: flexion, extension, right and left side bending, and right and left rotation), and pain pressure threshold (average obtained for six evaluation points). Secondary outcome measures will include neck range of motion in the sagittal, coronal, and transverse planes and neck disability.
In this study, HILT's effects on patients with non-specific NP will be compared to those of a sham laser intervention. This RCT will offer new evidence regarding the potential benefits of HILT in terms of pain intensity, range of movement, and disability in people suffering with non-specific NP.
ClinicalTrials.gov NCT05689788. January 19, 2023.
慢性非特异性颈痛（CNNP）是一种常见的肌肉骨骼疾病，其致残率和经济负担都很高，在肌肉骨骼疾病中仅次于腰痛。物理疗法为 CNNP 提供了有效的干预措施，包括低水平激光疗法（LLLT）。高强度激光疗法（HILT）是一种治疗肌肉骨骼疼痛的新方法，但支持其用于 CNNP 的研究有限。本研究旨在评估高强度激光疗法对 CNNP 患者疼痛强度的影响，鉴于目前关于 LLLT 对该疾病的研究。
这是一项双臂、随机、安慰剂对照试验，评估人员设盲。研究将在安第斯·贝洛大学坎索纳·德拉斯·孔德斯校区的物理因子实验室进行。符合条件的参与者包括患有慢性非特异性 NP 的安第斯·贝洛大学内外社区的所有人。参与者将按性别（4 个亚组）分层，随机分为 2 个研究组：组 1（HILT 和伸展运动）和组 2（假 HILT 和伸展运动）。治疗将每周进行 2 次，持续 4 周，共进行 3 次评估：治疗前（T0）、治疗结束时（T1）和治疗后 12 周（随访）（T2）。主要结局指标为静息时疼痛强度、运动时疼痛强度（主动颈椎运动：前屈、后伸、左右侧屈和左右旋转）和疼痛压力阈值（6 个评估点的平均值）。次要结局指标包括矢状面、冠状面和横断面的颈椎活动度以及颈椎功能障碍。
在这项研究中，将比较 HILT 对非特异性 NP 患者的影响与假激光干预的影响。这项 RCT 将提供有关 HILT 在减轻非特异性 NP 患者疼痛强度、活动范围和残疾方面潜在益处的新证据。
ClinicalTrials.gov NCT05689788。2023 年 1 月 19 日。
