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临床试验/NCT02168517
NCT02168517Unknown不适用

Obesity, Pain and Fertility: is There Any Association?

Northern Orthopaedic Division, Denmark1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Progressive motility

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Progressive motility

时间窗: 6 months

Progressive motility as in the world health organization lower reference limits for sperm quality.

次要结局

  • Pain(6 months)

研究者

发起方
Northern Orthopaedic Division, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (1)

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