Correlation of Pain, Obesity and Fertility Potential. | NCT02168517

Studies
Correlation of Pain, Obesity and Fertility Potential.

NCT02168517

Sponsor

Northern Orthopaedic Division, Denmark

Status

Unknown status

Last Update Posted

May 28, 2015Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Overweight and Obesity

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jun 18, 2014

First Submission Date that Met QC Criteria

Jun 18, 2014

First Posted Date

Jun 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 28, 2015Estimated

Name	Class
Aalborg University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I		Overweight osteoarthritis patients
Group II		Normal weight osteoarthritis patients.
Group III		Overweight healthy men.
Group IV		Normal weight healthy men.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sten Rasmussen, M.D.	Contact			sten.rasmussen@rn.dk
Hans I. Nielsen, PhD	Contact			hin@hst.aau.dk

Overall Officials

Name	Affiliation	Role
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	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital	Recruiting	Aalborg		DK-9000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity
D010146	Pain

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Description

A research biobank will be established during the project period. Majority of each sperm sample will be analyzed immediately but approximately 250 ul seminal plasma will be frozen and later analyzed at Aalborg University Biotechnology Department.