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Correlation of Pain, Obesity and Fertility Potential.

27. mai 2015 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Overvekt og fedme

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

120

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Danmark
- - Aalborg, Danmark, DK-9000
    - Rekruttering
    - Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
    - Ta kontakt med:
      
      Sten Rasmussen, M.D.
      
      E-post: sten.rasmussen@rn.dk
    - Underetterforsker:
      
      Fereshteh Dardmeh, PhD stud.
    - Hovedetterforsker:
      
      Sten Rasmussen, M.D
    - Hovedetterforsker:
      
      Hans I. Nielsen, PhD, MSc
    - Underetterforsker:
      
      Parisa Gazerani, PhD
    - Underetterforsker:
      
      Hiva Alipour, PhD stud.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Primary care clinic

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Case-Control
Tidsperspektiver: Retrospektiv

Antall grupper / kohorter

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Progressive motility Tidsramme: 6 months	Progressive motility as in the world health organization lower reference limits for sperm quality.	6 months

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Pain Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Northern Orthopaedic Division, Denmark

Samarbeidspartnere

Aalborg University

Etterforskere

Studieleder: Sten Rasmussen, M.D., Clinic for Neuro- and Orthopaedic Diseases, Aalborg University Hospital
Studieleder: Hans I. Nielsen, PhD, Department of Health Science and Technology, Aalborg University
Hovedetterforsker: Fereshteh Dardmeh, PhD stud., Department of Health Science and Technology, Aalborg University
Studiestol: Parisa Gazerani, PhD, Department of Health Science and Technology, Aalborg University
Studiestol: Hiva Alipour, PhD stud., Department of Health Science and Technology, Aalborg University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2014

Primær fullføring (Forventet)

1. desember 2015

Studiet fullført (Forventet)

1. desember 2015

Datoer for studieregistrering

Først innsendt

18. juni 2014

Først innsendt som oppfylte QC-kriteriene