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Correlation of Pain, Obesity and Fertility Potential.

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ClinicalTrials.gov Identifier: NCT02168517
Recruitment Status : Unknown
Verified May 2015 by Northern Orthopaedic Division, Denmark.
Recruitment status was:  Recruiting
First Posted : June 20, 2014
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

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.

Condition or disease
Overweight and Obesity

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Obesity, Pain and Fertility: is There Any Association?
Study Start Date : May 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

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



Primary Outcome Measures :
  1. Progressive motility [ Time Frame: 6 months ]
    Progressive motility as in the world health organization lower reference limits for sperm quality.


Secondary Outcome Measures :
  1. Pain [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
A research biobank will be established during the project period. Majority of each sperm sample will be analyzed immediately but approximately 250 ul seminal plasma will be frozen and later analyzed at Aalborg University Biotechnology Department.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary care clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168517


Contacts
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Contact: Sten Rasmussen, M.D. sten.rasmussen@rn.dk
Contact: Hans I. Nielsen, PhD hin@hst.aau.dk

Locations
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Denmark
Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital Recruiting
Aalborg, Denmark, DK-9000
Contact: Sten Rasmussen, M.D.       sten.rasmussen@rn.dk   
Sub-Investigator: Fereshteh Dardmeh, PhD stud.         
Principal Investigator: Sten Rasmussen, M.D         
Principal Investigator: Hans I. Nielsen, PhD, MSc         
Sub-Investigator: Parisa Gazerani, PhD         
Sub-Investigator: Hiva Alipour, PhD stud.         
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Aalborg University
Investigators
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Study Director: Sten Rasmussen, M.D. Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
Study Director: Hans I. Nielsen, PhD Department of Health Science and Technology, Aalborg University
Principal Investigator: Fereshteh Dardmeh, PhD stud. Department of Health Science and Technology, Aalborg University
Study Chair: Parisa Gazerani, PhD Department of Health Science and Technology, Aalborg University
Study Chair: Hiva Alipour, PhD stud. Department of Health Science and Technology, Aalborg University
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Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT02168517    
Other Study ID Numbers: N-20140025
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Northern Orthopaedic Division, Denmark:
Obesity
Pain
Fertility
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight