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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain
Secondary ID [1] 0 0
Pain-OMICS RT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent/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
30 months
Secondary outcome [1] 0 0
GLYCOMIC AND ACTIVOMIC OUTCOME
Timepoint [1] 0 0
30 months
Secondary outcome [2] 0 0
STRATIFICATION OF OUR POPULATION
Timepoint [2] 0 0
30 months

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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
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

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MASSIMO ALLEGRI, MD
Address 0 0
Fondazione IRCCS Policlinico San Matteo di Pavia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02037789