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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/NCT02037763
Registration number
NCT02037763
Ethics application status
Date submitted
14/01/2014
Date registered
16/01/2014
Date last updated
26/09/2016
Titles & IDs
Public title
A Prospective Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain
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Scientific title
A Prospective Controlled Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain
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Secondary ID [1]
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Pain-OMICS PRT
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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:
Acute Low Back Pain
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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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To investigate the associations between genetic factors and the development of persistent chronic LBP, in patients developing persistent chronic symptoms (defined as pain that persists 3 months or more), after an episode of acute LBP. The development of persistent chronic pain will be assessed at 3 months after the acute episode.
Existing and newly generated GWAs will be analyzed and their possible correlation with the risk of pain becoming persistent chronic will be detected in a wide, international population of caucasian ancestry.
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Timepoint [1]
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54 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 patients who develop CLBP compared to patients who do not develop CLBP after an episode of acute LBP. 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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54 months
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Secondary outcome [2]
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Epigenetic outcome
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Assessment method [2]
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Investigators will identify CpG methylation patterns that may be associated with the development and maintenance of persistent chronic LBP pain after an episode of acute LBP in the first 200 patients who develop CLBP and first 200 patients who will not develop it.
In the same cohort of 400 patients, investigators will analyze microRNAs (miRNAs) to investigate their role in predicting risk of persistent chronic pain after acute episode, opioid tolerance and response to therapy after the beginning of opioid therapy.
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Timepoint [2]
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54 months
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Secondary outcome [3]
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Next-generation sequencing outcome
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Assessment method [3]
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Investigators will detect rare variants with strong or modest effects on LBP symptoms and response to therapy using next generation sequencing of candidate genes in 200 incident cases with persistent chronic pain and 200 controls. In particular, investigators will analyze new genetic variants that may impact on intervertebral disc stability, new variants modifying inflammation, variants of pain signalling, new variants in genes encoding analgesic drug metabolism and other genes from literature search.
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Timepoint [3]
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54 months
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Secondary outcome [4]
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Stratification based on pain characteristics
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Assessment method [4]
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"Omics" data will be compared stratifying our population according to pain characteristics, pain intensity, response to treatment and duration of pain.
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Timepoint [4]
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54 months
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Secondary outcome [5]
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Stratification based on pain pathophysiology
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Assessment method [5]
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In a subgroup of patients, "omics" data will be compared stratifying our population according to pain pathophysiology: discogenic pain, spinal stenosis, facet joint pain, sacroiliac joint pain, low back pain with radicular pain (radicular pain not predominant) and widespread low back pain.
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Timepoint [5]
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54 months
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Secondary outcome [6]
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Stratification based on 6 months follow-up
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Assessment method [6]
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"Omics" data will be also compared stratifying our population according to the persistence of pain at 6 months despite receiving a treatment following current guidelines.
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Timepoint [6]
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54 months
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Eligibility
Key inclusion criteria
- age: older than 18;
- acute episode of pain between the costal margins and gluteal fold, with or without
symptoms into one or both legs lasting less than 6 weeks;
- 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?
No
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Key exclusion criteria
- evidence of clinically unstable disease;
- severe psychiatric disorder (excluding mild depression) or mental impairment;
- history (in the last 6 months) of persistent chronic low back pain or acute LBP
episodes
- 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
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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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
1/12/2014
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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
1/08/2018
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Actual
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Sample size
Target
5000
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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
Country [1]
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United States of America
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State/province [1]
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North Carolina
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Country [2]
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Belgium
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State/province [2]
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Genk
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Country [3]
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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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Country [6]
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United Kingdom
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State/province [6]
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London
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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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Country
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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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Country [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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Country [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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Country [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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Country [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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Country [5]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a prospective observational cohort multinational clinical study. There are no
biomarkers to help predict in which patients acute low back pain (LBP) will transform into
chronic low back pain (CLBP). Human variability and different common comorbidities complicate
the picture and make stratification of patients into correct subgroups difficult. However,
drugs act by targeting specific molecular pathways and are therefore efficient only in a
subgroup of patients sharing common molecular pathology and common genetics. Both CLBP and
disc degeneration are known to be heritable. Little investigation has taken place for genetic
variants in CLBP. The main aim of this trial is to identify "omics biomarkers" associated
with the transition from acute (single episode of low back pain) to persistent/chronic LBP
(pain lasting more than 12 weeks).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02037763
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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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Pain Therapy Service Azienda Ospedaliera Universitaria Parma Italy
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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MASSIMO ALLEGRI, MD
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Address
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Country
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Phone
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02037763
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