- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02955407
Genetic Predisposition for Chronic Non-specific Low Back Pain (Backgene)
January 22, 2019 updated by: Balgrist University Hospital
Genetic Predisposition for Reduced Back Muscle Strength and Back Muscle Endurance in Patients With Chronic Non-specific Low Back Pain
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).
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zurich, Switzerland, 8008
- Balgrist University Hospital
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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
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic low back pain and healthy controls without low back pain.
Description
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)
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Low back pain patients
Low back pain since more than 3 months Age: 18-65 Caucasian race
|
observational case-control study
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Controls without low back pain
no low back ain Age: 18-65 Caucasian race
|
observational case-control study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Polymorphism ACE Gene
Time Frame: baseline
|
baseline
|
Polymorphism Tenascin Gene
Time Frame: baseline
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Back muscle endurance in Sorensen test
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Martin Flück, Professor, Balgrist University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vaughan D, Huber-Abel FA, Graber F, Hoppeler H, Fluck M. The angiotensin converting enzyme insertion/deletion polymorphism alters the response of muscle energy supply lines to exercise. Eur J Appl Physiol. 2013 Jul;113(7):1719-29. doi: 10.1007/s00421-012-2583-6. Epub 2013 Feb 9.
- Shehab DK, Al-Jarallah KF, Al-Awadhi AM, Al-Herz A, Nahar I, Haider MZ. Association of angiotensin-converting enzyme (ACE) gene insertion-deletion polymorphism with spondylarthropathies. J Biomed Sci. 2008 Jan;15(1):61-7. doi: 10.1007/s11373-007-9203-1. Epub 2007 Aug 23.
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
September 1, 2016
Primary Completion (Actual)
August 31, 2018
Study Completion (Actual)
August 31, 2018
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
November 3, 2016
First Posted (Estimate)
November 4, 2016
Study Record Updates
Last Update Posted (Actual)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 22, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-00647
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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