跳至主要内容
临床试验/NCT05080374
NCT05080374已完成不适用

Effects of Combining High Speed Low Amplitude Spinal Manipulation (HVLA) With Functional Elastic Bandage, Diaphragm Training and a Lumbar Exercise Program in Patients With Nonspecific Low Back Pain: a Randomized Clinical Trial.

Ignacio Alejandro Astudillo Ganora1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Biomechanical changes (shober test)

研究概览

简要总结

Introduction: Nonspecific low back pain is the most common cause of visits to medical personnel and is the largest cause of absenteeism in the world. (1), Nonspecific low back pain accounts for 85% of low back pain, notably affecting quality of life and working life (2), There is a 50-70% probability that a person will have low back pain during their life ( 3), lumbago produces 300,000 years lived with disability (ADL), being the first burden of disease in Chile, surpassing hypertensive heart disease and depression (4). There are many therapeutic approaches to the management of nonspecific low back pain, including high-speed, low-amplitude spinal manipulations (5). This technique consists of applying a short and rapid force at the level of the joint that is restricted, in order to restore normal joint mobility. The physiological effects of manipulations are not sufficiently studied, but some authors (6) (7) suggest that the nervous system is the mediator of the effects of spinal manipulation. Among non-pharmacological interventions, numerous clinical guidelines recommend the use of therapeutic exercise for low back pain (8), including a wide variety of types of recommended exercises, the most traditionally recommended being aerobic exercises, exercises that involve stretching postures of the back. vertebral musculature, strengthening and strength exercises (9) and central stabilization exercises (10). Recently, the effects of inspiratory muscle and diaphragm training exercises in patients with low back pain are being investigated (11). The application of an elastic bandage (12) in the lumbar area generates a proprioceptive signal through the skin, producing analgesia and a feeling of support in the area.

Objectives: To compare the effects of different therapeutic approaches in combination with spinal manipulation.

Design and method: Single-blind randomized clinical trial Results: Significant differences are expected before and after treatment and differences between groups.

Conclusion: The aims of this study is to demonstrate that High speed and low amplitude spinal manipulation plus other conservative treatment is a valid therapeutic strategy for the management of nonspecific low back pain

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • older than 18 years
  • with nonspecific low back pain

排除标准

  • chronic low back pain (more than 3 months)
  • spinal surgeries
  • red flags for spinal manipulation (osteoporosis, bone metastasis, etc)

结局指标

主要结局

Biomechanical changes (shober test)

时间窗: baseline after 6 weeks and a month

observe the changes in the biomechanics of the spine through the Shober test (Schöber test. It is performed with the patient standing and the examiner on his back. A point is indicated that locates L5 (at the height of the dimples of Venus or the iliac crests are used, which correspond to L4, and is marked 1cm below) and a second point is marked 10cm above.)

Biomechanical changes (lateral tilt test)

时间窗: baseline after 6 weeks and a month

observe the changes in the biomechanics of the spine through the lateral tilt test (centimeters from the tip of the middle finger to the ground)

changes in function

时间窗: baseline after 6 weeks and a month

observe changes in disability due to nonspecific low back pain through the Oswestry test (The Oswestry Test comprises 10 items, of 10 points each, with a maximum of 100, this score being the worst possible functional state.)

changes in pain EVA

时间窗: baseline after 6 weeks and a month

observe changes in pain through visual analogue scale (VAS) 0 to 10

Changes in pain pressure algometers

时间窗: baseline after 6 weeks and a month

observe changes in pain in painful points through a pressure monitor (painmeter) (0 to 10 kilograms 0 to 22 pounds)

biomechanical changes (finger-floor test)

时间窗: baseline after 6 weeks and a month

observe the changes in the biomechanics of the spine through the finger-floor test (centimeters from the tip of the middle finger to the ground)

次要结局

未报告次要终点

研究者

发起方
Ignacio Alejandro Astudillo Ganora
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ignacio Alejandro Astudillo Ganora

Physiotherapist, Phd

Universidad de Murcia

研究点 (1)

Loading locations...

相似试验