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临床试验/NCT06757400
NCT06757400已完成不适用

Τhe Effect of Lumbar Spine Mobilization and Manipulation on Pressure Pain Threshold in Patients with Non-specific Chronic Low Back Pain: a Cross-over Randomised Controlled Trial

University of West Attica1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
1. Pressure pain threshold

研究概览

简要总结

Manual therapy, including mobilizations and manipulations, appears to be as effective as other types of therapy for chronic low back pain.

The aim of this cross-sectional study is to compare the effects of lumbar spine mobilization and manipulation on the pressure pain threshold in patients with non-specific chronic low back pain.

详细描述

Background: Manual therapy, including mobilizations and manipulations, appears to be equally effective as other types of therapy for chronic low back pain. According to the Orthopaedic Section of the American Physical Therapy Association (APTA), there is evidence indicating that these techniques can reduce pain, improve spinal and hip mobility, and decrease disability in patients with low back pain. The aim of this study is to compare the effects of lumbar spine mobilization and manipulation on the pressure pain threshold in patients with non-specific chronic low back pain.

Methods: The present study will be a cross-sectional study in which participants will be men and women aged 18 to 60 years. The sample size was estimated by effect size, with a minimum of 27 participants required to provide statistically or clinically significant results. Each subject will receive two interventions-mobilization or manipulation-on two different days, in a random order. The primary outcomes will be pain perception, including subjective pain intensity and pressure pain threshold. Secondary outcomes will include the range of motion (ROM) of lumbar spine flexion, extension, and lateral flexion. Data will be collected before and after each intervention. Assessors will use a digital algometer, an electronic inclinometer, and a numerical rating scale (NRS). ANOVA and t-test calculations will be performed on data processed by SPSS Version 25 to analyze results for all outcomes. The level of significance will be set at 5% (p = 0.05) with a confidence interval of 95% (CI = 95%).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 to 60 years old
  • •diagniosed with non specific low back pain
  • •symptoms lasting for more than 12 weeks

排除标准

  • •spinal fractures,
  • •neurological impairment due to herniated spinal disc,
  • •spondylolisthesis,
  • •joint degenerative diseases,
  • •osteoporosis,
  • •spinal infections,
  • •cauda equina syndrome,
  • •spinal tumors or bone marrow malignancies,
  • •spinal surgeries
  • •history of cancer,
  • •use of steroids

研究组 & 干预措施

Mobilization

Experimental

27 patients with chronic low back pain will be assigned to receive one intervention with grade IV posteroanterior (PA) mobilization in the Lumbar spine

干预措施: Mobilization (Other)

Mobilization

Experimental

27 patients with chronic low back pain will be assigned to receive one intervention with grade IV posteroanterior (PA) mobilization in the Lumbar spine

干预措施: manipulation (Other)

Manipulation

Active Comparator

27 patients with chronic low back pain will be assigned to receive one intervention with lumbar manipulation

干预措施: Mobilization (Other)

Manipulation

Active Comparator

27 patients with chronic low back pain will be assigned to receive one intervention with lumbar manipulation

干预措施: manipulation (Other)

结局指标

主要结局

1. Pressure pain threshold

时间窗: Baseline and 15 minutes

Changes between pre- and post- intervention in Pressure Pain Threshold will be measured using at the L5 spinous process, upper trapezius muscle the tibialis anterior muscle. The COMPACT DIGITAL ALGOMETER CAPACITIES TO: 100 lbf / 50 kgf / 500 N, will be used by an independent assessor. The assessor will be blinded to participants' group.

次要结局

  • Range Of Motion (ROM)(Baseline and 15 minutes)
  • Pain Intensity(Baseline and 15 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefanos Karanasios

Associate Professor, Physiotherapy Dept, University of West Attica

University of West Attica

研究点 (1)

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