Overweight and ObesityNCT02168517
Correlation of Pain, Obesity and Fertility Potential.
An observational study of Overweight and Obesity, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Primary care clinic
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Patients with a pain rate below 3
- Medication
- Patients taking Morphine drugs
Trial locations and contacts
1 site in 1 country.
Sten Rasmussen, M.D. contact
Hans I. Nielsen, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
Aalborg, DK-9000
Sten Rasmussen, M.D., sten.rasmussen@rn.dk
Fereshteh Dardmeh, PhD stud.
About this study
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Pain, Fertility
- Medical subject headings
- Overweight, Obesity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Overweight osteoarthritis patients | |
| Group II | Normal weight osteoarthritis patients. | |
| Group III | Overweight healthy men. | |
| Group IV | Normal weight healthy men. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive motility
Progressive motility as in the world health organization lower reference limits for sperm quality.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., Study director, Clinic for Neuro- and Orthopaedic Diseases, Aalborg University HospitalHans I. Nielsen, PhD, Study director, Department of Health Science and Technology, Aalborg UniversityFereshteh Dardmeh, PhD stud., Principal investigator, Department of Health Science and Technology, Aalborg UniversityParisa Gazerani, PhD, Study chair, Department of Health Science and Technology, Aalborg UniversityHiva Alipour, PhD stud., Study chair, Department of Health Science and Technology, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168517
- Sponsor's protocol ID
- N-20140025
- Status last verified
- May 2015
- First submitted
- 18 Jun 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity, Pain and Fertility: is There Any Association?
- ClinicalTrials.gov ID
- NCT02168517
- Acronym / sponsor ID
- N-20140025
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Pain, Fertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –Overweight osteoarthritis patients |
| Group II | – | –Normal weight osteoarthritis patients. |
| Group III | – | –Overweight healthy men. |
| Group IV | – | –Normal weight healthy men. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progressive motility
Time frame: 6 months
Progressive motility as in the world health organization lower reference limits for sperm quality.
1 secondary outcome
Pain
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten Rasmussen, M.D. contact
Hans I. Nielsen, PhD contact
Sten Rasmussen, M.D. study director
Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
Hans I. Nielsen, PhD study director
Department of Health Science and Technology, Aalborg University
Fereshteh Dardmeh, PhD stud. principal investigator
Department of Health Science and Technology, Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sten Rasmussen, M.D. (sten.rasmussen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive motility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.