Rehabilitation Science Postgraduation Program, Augusto Motta University Centre (UNISUAM), Rio de Janeiro, Brazil.
Physiotherapy Department, Midwestern Parana State University (UNICENTRO), Paraná, Brazil.
Trials. 2022 Mar 3;23(1):188. doi: 10.1186/s13063-022-06111-4.
Low back pain is one of the main public health concerns. Chronic low back pain (cLBP) reduces functional capacity and affects postural stability. Although health professionals widely use spinal manipulation, its immediate effect on painful sensitivity and postural stability is lacking. This study aims to verify the immediate effects of lumbar spinal manipulation on the pressure pain threshold and postural stability in individuals with cLBP.
A two-arm, placebo-controlled clinical trial with parallel groups and examiner-blinded will be conducted with 80 participants with cLBP from an outpatient physical therapy department, randomly allocated at a 1:1 distribution. The experimental group will receive a lumbar spinal manipulation technique, and the placebo group will receive a simulated lumbar spinal manipulation. Both groups will receive one session of treatment and will be evaluated before and immediately after the intervention. The primary outcomes will be the pressure pain threshold and postural stability. Pain intensity and patient's expectation will be assessed as a secondary outcome. The pressure pain threshold will be assessed using a pressure algometer in 6 different anatomical regions. The evaluation of postural stability will be performed in a baropodometry exam by displacing the centre of pressure. The pain intensity will be measured using the Numeric Pain Rating Scale. A Likert scale will be used for the patient's expectation about the treatment. A two-way analysis of variance will compare the effect of the interventions between groups.
This study will provide insights regarding the immediate effects of spinal manipulation in patients with cLBP against a simulated spinal manipulation using objective outcomes and considering patients' expectations regarding the treatment.
Brazilian Registry of Clinical Trials RBR-3ksq2c . Registered on 13 July 2020.
下腰痛是主要的公共卫生问题之一。慢性下腰痛(cLBP)降低了功能能力并影响了姿势稳定性。尽管健康专业人员广泛使用脊柱推拿,但它对疼痛敏感性和姿势稳定性的即时影响仍不清楚。本研究旨在验证腰椎脊柱推拿对 cLBP 患者的压痛阈值和姿势稳定性的即时影响。
这是一项双臂、安慰剂对照、平行组、检查者盲法的临床试验,将从门诊物理治疗科招募 80 名 cLBP 患者,按 1:1 的比例随机分组。实验组将接受腰椎脊柱推拿技术,而安慰剂组将接受模拟腰椎脊柱推拿。两组均接受一次治疗,在干预前后进行评估。主要结局指标为压痛阈值和姿势稳定性。疼痛强度和患者的预期将作为次要结局进行评估。压痛阈值将使用压力测痛计在 6 个不同的解剖区域进行评估。姿势稳定性的评估将通过压力中心的位移在足压计检查中进行。疼痛强度将使用数字疼痛评分量表进行测量。患者对治疗的预期将使用李克特量表进行评估。将使用双向方差分析比较组间干预的效果。
本研究将通过客观结果并考虑患者对治疗的预期,提供有关脊柱推拿对 cLBP 患者即时影响的见解,与模拟脊柱推拿进行对比。
巴西临床试验注册处 RBR-3ksq2c。于 2020 年 7 月 13 日注册。