Genetic Predisposition for Chronic Non-specific Low Back Pain

Low Back Pain Clinical Trial

— Backgene  

Official title:

Genetic Predisposition for Reduced Back Muscle Strength and Back Muscle Endurance in Patients With Chronic Non-specific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955407
• Other study ID #: 2016-00647
• Status: Completed
• Start date: September 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: January 2019
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Disease Susceptibility
• Genetic Predisposition to Disease
• Low Back Pain

Intervention

Other:
• no intervention
observational case-control study

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. Epub 2007 Aug 23. — View Citation

Vaughan D, Huber-Abel FA, Graber F, Hoppeler H, Flück 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polymorphism ACE Gene		baseline
Primary	Polymorphism Tenascin Gene		baseline
Secondary	Back muscle endurance in Sorensen test		baseline