Correlation of Pain, Obesity and Fertility Potential.

May 27, 2015 updated by: Northern Orthopaedic Division, Denmark

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9000
        • Recruiting
        • Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
        • Contact:
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progressive motility
Time Frame: 6 months
Progressive motility as in the world health organization lower reference limits for sperm quality.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Aalborg University

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20140025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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