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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Prospective Controlled Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain
Secondary ID [1] 0 0
Pain-OMICS PRT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Low Back Pain 0 0
Chronic Low Back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Genetic outcome
Timepoint [1] 0 0
54 months
Secondary outcome [1] 0 0
Glycomic and Activomic outcome
Timepoint [1] 0 0
54 months
Secondary outcome [2] 0 0
Epigenetic outcome
Timepoint [2] 0 0
54 months
Secondary outcome [3] 0 0
Next-generation sequencing outcome
Timepoint [3] 0 0
54 months
Secondary outcome [4] 0 0
Stratification based on pain characteristics
Timepoint [4] 0 0
54 months
Secondary outcome [5] 0 0
Stratification based on pain pathophysiology
Timepoint [5] 0 0
54 months
Secondary outcome [6] 0 0
Stratification based on 6 months follow-up
Timepoint [6] 0 0
54 months

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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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;

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2018
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Edith Cowan University (ECU) - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
Belgium
State/province [2] 0 0
Genk
Country [3] 0 0
Croatia
State/province [3] 0 0
Zabok
Country [4] 0 0
Italy
State/province [4] 0 0
Parma
Country [5] 0 0
Italy
State/province [5] 0 0
Pavia
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
University of Parma
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GENOS
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Ip Research Consulting Sasu
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Helmholtz Zentrum München
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
YURII AULCHENKO
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
King's College London
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT02037763
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MASSIMO ALLEGRI, MD
Address 0 0
Pain Therapy Service Azienda Ospedaliera Universitaria Parma Italy
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
MASSIMO ALLEGRI, MD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02037763