Clinical trial NCT02168517: Correlation of Pain, Obesity and Fertility Potential.
Official title: Obesity, Pain and Fertility: is There Any Association?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight and Obesity
Keywords: Obesity
Pain
Fertility
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2014-06-20
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progressive motility
timeFrame: 6 months
Secondary outcomes:
measure: Pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
Study officials:
affiliation: Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
name: Sten Rasmussen, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Health Science and Technology, Aalborg University
name: Hans I. Nielsen, PhD
role: STUDY_DIRECTOR
affiliation: Department of Health Science and Technology, Aalborg University
name: Fereshteh Dardmeh, PhD stud.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Health Science and Technology, Aalborg University
name: Parisa Gazerani, PhD
role: STUDY_CHAIR
affiliation: Department of Health Science and Technology, Aalborg University
name: Hiva Alipour, PhD stud.
role: STUDY_CHAIR
References: