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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02037789
Registration number
NCT02037789
Ethics application status
Date submitted
14/01/2014
Date registered
16/01/2014
Date last updated
26/09/2016
Titles & IDs
Public title
A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain
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Scientific title
A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain
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Secondary ID [1]
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Pain-OMICS RT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Persistent/Chronic Low Back Pain
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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GENETIC OUTCOME
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Assessment method [1]
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The primary objective is to recognize genetic variants associated with persistent CLBP patients compared to patients without chronic/persistent pain. Through a Genetic Wide Association Study (GWAS) investigators will correlate genetic variants associated with persistent CLBP in a wide, international population of European ancestry.
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Timepoint [1]
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30 months
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Secondary outcome [1]
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GLYCOMIC AND ACTIVOMIC OUTCOME
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Assessment method [1]
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Recognize Glycomic and Activomic data associated with persistent CLBP patients compared to patients without chronic/persistent pain. The sample size will better defined after the first interim analysis of first 400 patients.
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Timepoint [1]
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30 months
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Secondary outcome [2]
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STRATIFICATION OF OUR POPULATION
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Assessment method [2]
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All "omic" data will be compared stratifying our population according to:
Pathophysiology: discogenic pain, spinal stenosis, facet joint pain, sacroiliac joint pain, low back pain with radicular pain (not predominant radicular pain) and widespread pain.
pain intensity
response to treatment
duration of pain
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Timepoint [2]
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30 months
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Eligibility
Key inclusion criteria
Inclusion Criteria of patients with persistent CLBP:
- age: older than 18;
- chronic/persistent pain (pain lasting longer than 12 weeks) between the costal margins
and gluteal fold, with or without symptoms into one or both legs
- written informed consent signed;
- Caucasian ancestry
Inclusion Criteria of healthy volunteers:
- age: older than 18;
- without any chronic/persistent pain (pain lasting longer than 12 weeks) in the last
one year;
- written informed consent signed;
- Caucasian ancestry
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- evidence of clinically unstable disease;
- severe psychiatric disorder (excluding mild depression) or mental impairment;
- recent history ( < 1 year) of spinal fracture;
- pain in the back due to spinal tumor or infection;
- pregnancy
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2016
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Edith Cowan University (ECU) - Perth
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Recruitment postcode(s) [1]
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- Perth
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Recruitment outside Australia
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United States of America
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North Carolina
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Country [2]
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Belgium
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Genk
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Croatia
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State/province [3]
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Zabok
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Country [4]
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Italy
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State/province [4]
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Parma
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Country [5]
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Italy
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State/province [5]
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Pavia
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Parma
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Address
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Other collaborator category [1]
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Other
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Name [1]
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GENOS
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Ip Research Consulting Sasu
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Address [2]
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Other collaborator category [3]
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Commercial sector/Industry
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Name [3]
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Helmholtz Zentrum München
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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YURII AULCHENKO
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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King's College London
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Address [5]
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Ethics approval
Ethics application status
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Summary
Brief summary
Low back pain (LBP) is one of the most common medical problems encountered in daily life; it
is related to disability and work absence and accounts for high economical costs in Western
societies.
Low-back pain is a diverse group of mixed pain syndromes (neuropathic and nociceptive) with
different molecular pathologies at different structural levels displaying similar clinical
manifestations. Currently, there are limited biomarkers (mostly imaging) or clinical findings
that can be used objectively to help the physician in precise anatomic diagnosis leading to
the safest and most cost-effective treatment for the patient (reduction of direct and
indirect costs and improvement of treatment efficacy).
The main aim of this trial is to identify all "omics biomarkers" associated with
susceptibility to chronic/persistent LBP and its different pathophysiology.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02037789
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MASSIMO ALLEGRI, MD
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Address
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Fondazione IRCCS Policlinico San Matteo di Pavia
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02037789
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