Overweight and Obesity Clinical Trial
Official title:
Obesity, Pain and Fertility: is There Any Association?
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.
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 |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Denmark | Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Northern Orthopaedic Division, Denmark | Aalborg University |
Denmark,
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 |
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