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Correlation of Pain, Obesity and Fertility Potential.

2015年5月27日更新者：Northern Orthopaedic Division, Denmark

Obesity, Pain and Fertility: is There Any Association?

The overall aim of the study is to investigate if patients with musculoskeletal chronic pain have reduced semen quality in comparison with age matched healthy controls. Secondly, the aim is to investigate whether overweight with or without chronic pain are related to reduced semen quality. We will investigate semen quality in obese chronic pain patients, normal weight chronic pain patients and in obese and normal weight healthy controls.

研究概览

地位

未知

条件

超重和肥胖

详细说明

Obesity is associated with several disorders including chronic musculoskeletal pain. For example obesity has been implicated in the development or progression of low back pain and knee osteoarthritis. The mechanism by which obesity causes lumbar back pain is poorly understood, but the contribution of both mechanical and system factors is likely. Direct mechanical stress on the intervertebral discs and adjacent structures are suspected to be mechanisms through which obesity affects the spine, leading to subsequent low back pain. The link between obesity and knee osteoarthritis has also been demonstrated, but potential factors underlying the association of obesity with knee osteoarthritis has not entirely been elucidated.

It is a well-known fact that obesity leads to an excess load on the joint, increased cartilage turnover, increased collagen type 2 degradation products and increased risk of degenerative meniscal lesions. Although all of these factors have been proposed to lead to knee osteoarthritis, no causal relationship has been demonstrated.

研究类型

观察性的

注册 (预期的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

丹麦
- - Aalborg、丹麦、DK-9000
    - 招聘中
    - Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
    - 接触：
      
      Sten Rasmussen, M.D.
      
      邮箱：sten.rasmussen@rn.dk
    - 副研究员：
      
      Fereshteh Dardmeh, PhD stud.
    - 首席研究员：
      
      Sten Rasmussen, M.D
    - 首席研究员：
      
      Hans I. Nielsen, PhD, MSc
    - 副研究员：
      
      Parisa Gazerani, PhD
    - 副研究员：
      
      Hiva Alipour, PhD stud.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

男性

取样方法

概率样本

研究人群

Primary care clinic

描述

Inclusion Criteria:

Men between 18-45 years with low back pain or knee pain recruited among referees to the orthopaedic outpatient clinics at Aalborg University Hospital
Pain more than 3 months
Patients can be on a daily use of Paracetamol 1 gram x 4, NSAID x 3-4 or combined
Patients will be included regardless of their BMI but will be put in their respective BMI subgroup after the required measurements have been taken
Regarding low back pain the LBPRS >9, knee pain the KOOS <75 (0-100, i.c. 100 = no problems)
Healthy men in the age 18-45 years (matched with enrolled patients)

Exclusion Criteria:

Malignancy
Ongoing infection
Drug addiction defined as the use of cannabis, opioids or other psycho drugs
Previous neurologic, musculoskeletal or mental diseases
Lack of ability to cooperate
Pain rating
Patients with a pain rate below 3
Medication
Patients taking Morphine drugs

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：病例对照
时间观点：追溯

团体/队列数

队列和干预

团体/队列
Group I Overweight osteoarthritis patients
Group II Normal weight osteoarthritis patients.
Group III Overweight healthy men.
Group IV Normal weight healthy men.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Progressive motility 大体时间：6 months	Progressive motility as in the world health organization lower reference limits for sperm quality.	6 months

次要结果测量

结果测量	措施说明	大体时间
Pain 大体时间：6 months	The patients will be tested for their pain in terms of intensity and quality. Intensity will be rated on a visual analogue scale (VAS 0-10) for ongoing pain. Pressure pain will be measured by application of a handheld pressure algometer. A validated Danish version of short form McGill Pain Questionnaire will be given to evaluate the quality of pain. In addition, distribution of pain will be mapped by drawing on a body chart.	6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Northern Orthopaedic Division, Denmark

合作者

Aalborg University

调查人员

研究主任：Sten Rasmussen, M.D.、Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
研究主任：Hans I. Nielsen, PhD、Department of Health Science and Technology, Aalborg University
首席研究员：Fereshteh Dardmeh, PhD stud.、Department of Health Science and Technology, Aalborg University
学习椅：Parisa Gazerani, PhD、Department of Health Science and Technology, Aalborg University
学习椅：Hiva Alipour, PhD stud.、Department of Health Science and Technology, Aalborg University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年5月1日

初级完成 (预期的)

2015年12月1日

研究完成 (预期的)

2015年12月1日

研究注册日期

首次提交

2014年6月18日

首先提交符合 QC 标准的