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

Status

Completed

Conditions

Intervention / Treatment

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

      • Zurich, Switzerland, 8008
        • Balgrist University Hospital

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
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.

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.

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

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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