NCT02955407

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

October 6, 2016

Last Update Submit

January 22, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Polymorphism ACE Gene

    baseline

  • Polymorphism Tenascin Gene

    baseline

Secondary Outcomes (1)

  • Back muscle endurance in Sorensen test

    baseline

Study Arms (2)

Low back pain patients

Low back pain since more than 3 months Age: 18-65 Caucasian race

Other: no intervention

Controls without low back pain

no low back ain Age: 18-65 Caucasian race

Other: no intervention

Interventions

observational case-control study

Controls without low back painLow back pain patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic low back pain and healthy controls without low back pain.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 23397151BACKGROUND
  • 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.

    PMID: 17713861BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Flück, Professor

    Balgrist University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2016

First Posted

November 4, 2016

Study Start

September 1, 2016

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations