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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern Orthopaedic Division, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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