Low Back PainBackgeneNCT02955407
Genetic Predisposition for Chronic Non-specific Low Back Pain
An observational study of Low Back Pain, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2016to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic low back pain and healthy controls without low back pain.
Who may be able to join
- 18-65
Who cannot join
- Spinal surgery
- Spinal fracture
- Inflammation
- Tumour
- Severe chronic disease which make intensive physical activity impossible (osteoporosis, cardiovascular heart diseases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- no intervention
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
observational case-control study
| Study group | Role | What they receive |
|---|---|---|
| Low back pain patients | Low back pain since more than 3 months Age: 18-65 Caucasian race Receives: Other: no intervention | |
| Controls without low back pain | no low back ain Age: 18-65 Caucasian race Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymorphism ACE Gene
Measured: baseline
Polymorphism Tenascin Gene
Measured: baseline
Secondary outcomes (1)
Back muscle endurance in Sorensen test
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Flück, Professor, Study director, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955407
- Sponsor's protocol ID
- 2016-00647
- Other IDs
- 2016
- Acronym
- Backgene
- Status last verified
- Jan 2019
- First submitted
- 6 Oct 2016
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 23397151Shehab 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.
PubMed 17713861
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Predisposition for Reduced Back Muscle Strength and Back Muscle Endurance in Patients With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT02955407
- Acronym / sponsor ID
- Backgene / 2016-00647
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back pain patients | – | Other: no interventionLow back pain since more than 3 months Age: 18-65 Caucasian race |
| Controls without low back pain | – | Other: no interventionno low back ain Age: 18-65 Caucasian race |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic low back pain and healthy controls without low back pain.
Key inclusion criteria (1 listed)
- 18-65
Key exclusion criteria (5 listed)
- Spinal surgery
- Spinal fracture
- Inflammation
- Tumour
- Severe chronic disease which make intensive physical activity impossible (osteoporosis, cardiovascular heart diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionobservational case-control study | Other | Controls without low back pain, Low back pain patients |
Primary outcome
Polymorphism ACE Gene
Time frame: baseline
Polymorphism Tenascin Gene
Time frame: baseline
1 secondary outcome
Back muscle endurance in Sorensen test
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Background: PubMed 23397151Vaughan 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.
- Background: PubMed 17713861Shehab 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Flück, Professor study director
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polymorphism ACE Gene (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02955407, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.