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临床试验/NCT06399497
NCT06399497尚未招募不适用

Effects of Lumbar Spinal Manipulation on Muscle Mechanical Properties, Pressure Pain Threshold and Mechanical Perception Threshold in Subjects With Chronic Low Back Pain

Universidad de Córdoba2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
34
试验地点
2
主要终点
Muscle mechanical propierties

研究概览

简要总结

This study aims to measure the effects of spinal manipulation on Chronic Spinal Pain by assessing Muscle Mechanical Properties (MMPs) using MyotonPRO®, Mechanical Perception Threshold (MPT) using Von Frey monofilaments, and Pressure Pain Threshold (PPT) using an algometer. Participants will be randomly assigned to either spinal manipulation or placebo groups to compare effects on MMPs, MPT, and PPT. Assessments will occur at three time points: baseline, immediately post-intervention (real or simulated), and 24 hours post-intervention. This research targets individuals with chronic spinal pain, providing insights into the potential benefits of spinal manipulation in managing this condition.

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 (Outcomes Assessor)

盲法说明

The assessor will be blinded to the intervention assigned to each participant.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject with chronic low back pain

排除标准

  • Spinal trauma or surgery history.
  • Spinal congenital deformities.
  • Inflammatory or autoimmune disease
  • Herniated disc in the segment L
  • Pregnant women.
  • Body Mass Index > 30kg/m2
  • Subjects that have received treatment for low back pain in the seven days prior to the study.

结局指标

主要结局

Muscle mechanical propierties

时间窗: From enrollment to the end of treatment at 24 hours

The measurements will be performed with the MyotonPro®. The subject will be positioned in prone position with both upper limbs around the body. They will be asked to breathe apnea for five seconds after exhaling to reduce the abdominal influence on the test. Measurements at the lumbar level will be performed by positioning the MyotonPro® probe perpendicular to the muscle belly of the erector spinae, 2.5 cm from the midline of the spinous process of L5. A measurement of the tibialis anterior will assess the effect of the remote manipulation. For this purpose, the subject will be positioned in supine decubitus with the lower limb in extension. A point will be located on the tibialis anterior muscle, three finger traverses from the crest of the tibia in a caudal direction.

次要结局

  • Pressure pain threshold(From enrollment to the end of treatment at 24 hours)
  • Mechanical perception threshold(From enrollment to the end of treatment at 24 hours)

研究者

发起方
Universidad de Córdoba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lourdes García Luque

Principal Investigator

Universidad de Córdoba

研究点 (2)

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