跳至主要内容
临床试验/NCT05568758
NCT05568758招募中不适用

Effects of Combining Thoracic Lymphatic Pump Technique and Exercises on Patients With Chronic Mechanical Low Back Pain

Cairo University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

The purpose of the study is to compare between the combined effect of thoracic lymphatic pump technique with exercises and exercises alone on pain intensity using Visual Analogue Scale (VAS), lumbar spine mobility using Modified-Modified Schober test (MMST) and functional disability level using Oswestary Disability Index (ODI) on patients with CMLBP.

详细描述

Study design: This study will be randomizaed controlled trail.1. Participants:forty-two patients with chronic mechanical low back pain. age:20-45. Th sample size population: was calculated using the G*power program 3.1.9 (G power program version 3.1, Heinrich-Heine-University, Düsseldorf, Germany) for one tailed test. Sample size calculation based on F tests (ANOVA: Special effects and interactions), Type I error (a) = 0.05, power (1-ß error probability) = 0.80, Pillai V = 0.3300000 and effect size f (V) = 0.8 with 2 independent groups comparison for 3 major variable outcomes. The appropriate minimum sample size for this study was 42 patients (21 patients in each group). Procedure:First, the purpose of the study will be explained to the patients and the procedures are fully explained. Then, patients will be asked to participate in the study. If they accepted, an informed consent form will be signed and randomly assigned in one of two groups (by closed envelope method). All subjects will be evaluated for their pain intensity,lumbar spine mobility and functional disability level. All patients will be tested before and after the treatment program (12 treatment sessions, 3 sessions per week for 4 weeks). Each patient will receive exercises (stretching and strengthening exercises) for the control group (A), the stretching exercises include (Hamstring stretching- Lower back stretching) and the strengthening exercises- include (Abdominal curl up- Supine bridging-Trunk extension). For the experimental group (B), they will receive exercises (stretching and strengthening exercises) then the thoracic lymphatic pump technique.

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
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (both genders) with a chief complain of Chronic mechanical low back pain without leg pain (Al Sulaimy et al., 2018).
  • Age of the patient 20- 45 years old (Al Sulaimy et al., 2018).
  • Pain more than three months

排除标准

  • Patient with Spondylolysis (Steele et al., 2016).
  • Patient with tumor, infection (Ulger et al., 2017).
  • Patient with cauda equina syndrome who need urgent surgery (Ulger et al., 2017).
  • Patients with previous lumber surgery (Amundsen et al., 2018).
  • Patient with Deep venous thrombosis (DVT) (Alves et al., 2020).
  • Patient with Congestive heart failure (Alves et al., 2020).
  • Patient with Renal failure (Forner-Cordero et al., 2021).
  • Patient with uncontrolled hypertension (Forner-Cordero et al., 2021).

结局指标

主要结局

Pain intensity

时间窗: 4 weeks

Arabic version of the Visual analogue scale (VAS) will be used, the subject will mark on a 0-10 graphic rating scale in which the (0) value indicating no pain, and (10) indicating the most severe pain experienced. Then a ruler will be used to measure the distance from zero, the recorded number will be rounded to the closest value

次要结局

  • Functional disability level(4 weeks)

研究者

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

Basma Hesham Hasaneen EL-Fayoumi

physical therapist

Cairo University

研究点 (2)

Loading locations...

相似试验