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Genetic Predisposition for Chronic Non-specific Low Back Pain (Backgene)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02955407
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

Brief Summary:
Patients with inflammatory back pain were shown to differ from healthy controls in genotype of the Angiotensin-converting enzyme (ACE), which regulates vasoconstriction/-dilatation. The aim of this study is to investigate whether genetic reduction of muscle perfusion might be a pathophysiological pathway of how genes influence chronic non-specific low back pain (LBP).

Condition or disease Intervention/treatment
Low Back Pain Other: no intervention

Detailed Description:

The following genes will be investigated:

  • Insertions-/deletions-polymorphism of the angiotensin-converting enzyme (ACE-I/D gene polymorphism; 3 genotypes: ACE-II, ACE-ID, ACE-DD).
  • Anti-adhesive extracellular matrix protein Tenascin-C: gene polymorphism rs2104772

The goals of this study are to investigate whether these genotypes correlate with 1) endurance of back muscles, 2) comorbidities such as asthma and diabetes and 3) the risk for LBP as assessed by a LBP-classification tool.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Genetic Predisposition for Reduced Back Muscle Strength and Back Muscle Endurance in Patients With Chronic Non-specific Low Back Pain
Study Start Date : September 2016
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
Low back pain patients
Low back pain since more than 3 months Age: 18-65 Caucasian race
Other: no intervention
observational case-control study

Controls without low back pain
no low back ain Age: 18-65 Caucasian race
Other: no intervention
observational case-control study




Primary Outcome Measures :
  1. Polymorphism ACE Gene [ Time Frame: baseline ]
  2. Polymorphism Tenascin Gene [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Back muscle endurance in Sorensen test [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic low back pain and healthy controls without low back pain.
Criteria

Inclusion Criteria:

  • 18-65

Exclusion Criteria:

  • Spinal surgery
  • Spinal fracture
  • Inflammation
  • Tumour
  • Severe chronic disease which make intensive physical activity impossible (osteoporosis, cardiovascular heart diseases)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955407


Locations
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Switzerland
Balgrist University Hospital
Zurich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
Investigators
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Study Director: Martin Flück, Professor Balgrist University Hospital
Publications:
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Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT02955407    
Other Study ID Numbers: 2016-00647
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Disease Susceptibility
Genetic Predisposition to Disease
Pain
Neurologic Manifestations
Disease Attributes
Pathologic Processes