Correlation of Pain, Obesity and Fertility Potential.

Overweight and Obesity Clinical Trial

Official title:

Obesity, Pain and Fertility: is There Any Association?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02168517
• Other study ID #: N-20140025
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2014
• Last updated: May 27, 2015
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: Sten Rasmussen, M.D.
• Email: sten.rasmussen[@]rn.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Obesity
• Overweight and Obesity

Locations

Country	Name	City	State
Denmark	Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progressive motility	Progressive motility as in the world health organization lower reference limits for sperm quality.	6 months	No
Secondary	Pain	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	No