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
|Condition or disease|
|Overweight and Obesity|
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.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|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|
Overweight osteoarthritis patients
Normal weight osteoarthritis patients.
Overweight healthy men.
Normal weight healthy men.
- Progressive motility [ Time Frame: 6 months ]Progressive motility as in the world health organization lower reference limits for sperm quality.
- 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
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
|Contact: Sten Rasmussen, M.D.||email@example.com|
|Contact: Hans I. Nielsen, PhDfirstname.lastname@example.org|
|Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, DK-9000|
|Contact: Sten Rasmussen, M.D. email@example.com|
|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.|
|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|