Correlation of Pain, Obesity and Fertility Potential.

NCT ID: NCT02168517

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group I

Overweight osteoarthritis patients

No interventions assigned to this group

Group II

Normal weight osteoarthritis patients.

No interventions assigned to this group

Group III

Overweight healthy men.

No interventions assigned to this group

Group IV

Normal weight healthy men.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role collaborator

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sten Rasmussen, M.D.

Role: STUDY_DIRECTOR

Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital

Hans I. Nielsen, PhD

Role: STUDY_DIRECTOR

Department of Health Science and Technology, Aalborg University

Fereshteh Dardmeh, PhD stud.

Role: PRINCIPAL_INVESTIGATOR

Department of Health Science and Technology, Aalborg University

Parisa Gazerani, PhD

Role: STUDY_CHAIR

Department of Health Science and Technology, Aalborg University

Hiva Alipour, PhD stud.

Role: STUDY_CHAIR

Department of Health Science and Technology, Aalborg University

Locations

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Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sten Rasmussen, M.D.

Role: CONTACT

Hans I. Nielsen, PhD

Role: CONTACT

Facility Contacts

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Sten Rasmussen, M.D.

Role: primary

Other Identifiers

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N-20140025

Identifier Type: -

Identifier Source: org_study_id

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