Persistent/Chronic Low Back PainNCT02037789
A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain
An observational study of Persistent/Chronic Low Back Pain, run by University of Parma at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent/Chronic Low Back Pain
- How many people
- Not given
- Where
- 6 sitesin 5 countries
- Study dates
- Mar 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases will be collected at each participating centre. Every effort will be made to accumulate a well phenotyped cohort of patients with persistent CLBP, sub-grouped into 6 categories: discogenic pain, spinal stenosis (congenital or acquired), facet joint pain, sacroiliac joint pain, low back pain with radicular pain (not predominant radicular pain) and widespread low back pain. Controls (patients without chronic/persistent pain as defined above) will be retrieved from 2 different sources: Existing biobanks of healthy subjects which have collected information about chronic/persistent back pain. Subjects from the companion prospective study on acute LBP who will not have developed CLBP. Age (decades) and gender distribution of controls will be similar to cases.
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Italy2 sites
Anesthesia and Pain Therapy Department, Università degli Studi di Parma (UNIPR)
Parma
Fondazione IRCCS Policlinico San Matteo (OSM)
Pavia
United States1 site
The Center for Clinical Research (CPI)
Winston-Salem, North Carolina
Croatia1 site
"St.Catharine" Orthopedics, Surgery, Neurology and Physical Medicine and Rehabilitation Specialty Hospital (St-Cat)
Zabok
About this study
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.
Read the detailed description
Retrospective observational multinational clinical study, with a case control design.
Investigators will compare "omic biomarkers" between patients with and without persistent chronic low back pain (CLBP).
"OMIC" biomarkers investigated will be genetics, glycomics and activomic. Genetics through GWA studies has already obtained important results in pain research; however concerning low back pain, there is not yet suitable genotype-phenotype correlations helpful to stratify patients.
Glycomics is an emerging field that has recently been identified as a priority for the next decade by the US National Academies of Science. Many common complex diseases will be associated with specific changes in glycan structures. In addition, common genetic polymorphisms influencing glycosylation and consequent differences in glycome composition could be important diagnostic and prognostic markers. The first studies reporting protein glycosylation in large human population samples have been recently published by partners in the consortium. Reliable identification of valid associations between specific glyco-phenotypes and predisposition for the development or progression of a specific disease requires analysis of thousands of patients.
Activomics: combines data about enzymatic activity of numerous numerous post-translational modification proteins in an integrated model which provides dynamic characterization of the current state of an organism. In this project information about numerous proteases, kinases, phosphatases and glycosidases will be collected and used to complement the existing phenotype information.
- Conditions
- Persistent/Chronic Low Back Pain
- Keywords
- pain, low back pain, GWAS, glycomics, activomics
- Medical subject headings
- Pain, Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
GENETIC OUTCOME
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.
Measured: 30 months
Secondary outcomes (2)
GLYCOMIC AND ACTIVOMIC OUTCOME
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.
Measured: 30 months
STRATIFICATION OF OUR POPULATION
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
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent/Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- GENOS, Ip Research Consulting Sasu, Helmholtz Zentrum München, YURII AULCHENKO, King's College London
- Responsible party
- Principal investigator, Massimo Allegri, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- MASSIMO ALLEGRI, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037789
- Sponsor's protocol ID
- Pain-OMICS RT
- Status last verified
- Sep 2016
- First submitted
- 14 Jan 2014
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Allegri M, De Gregori M, Minella CE, Klersy C, Wang W, Sim M, Gieger C, Manz J, Pemberton IK, MacDougall J, Williams FM, Van Zundert J, Buyse K, Lauc G, Gudelj I, Primorac D, Skelin A, Aulchenko YS, Karssen LC, Kapural L, Rauck R, Fanelli G; PainOMICS Group. 'Omics' biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study. BMJ Open. 2016 Oct 19;6(10):e012070. doi: 10.1136/bmjopen-2016-012070.
PubMed 27798002
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain
- ClinicalTrials.gov ID
- NCT02037789
- Acronym / sponsor ID
- Pain-OMICS RT
- Conditions
- Persistent/Chronic Low Back Pain
- Keywords
- pain, low back pain, GWAS, glycomics, activomics
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- GENOS, Ip Research Consulting Sasu, Helmholtz Zentrum München, YURII AULCHENKO, King's College London
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Retrospective observational multinational clinical study, with a case control design.
Investigators will compare "omic biomarkers" between patients with and without persistent chronic low back pain (CLBP).
"OMIC" biomarkers investigated will be genetics, glycomics and activomic. Genetics through GWA studies has already obtained important results in pain research; however concerning low back pain, there is not yet suitable genotype-phenotype correlations helpful to stratify patients.
Glycomics is an emerging field that has recently been identified as a priority for the next decade by the US National Academies of Science. Many common complex diseases will be associated with specific changes in glycan structures. In addition, common genetic polymorphisms influencing glycosylation and consequent differences in glycome composition could be important diagnostic and prognostic markers. The first studies reporting protein glycosylation in large human population samples have been recently published by partners in the consortium. Reliable identification of valid associations between specific glyco-phenotypes and predisposition for the development or progression of a specific disease requires analysis of thousands of patients.
Activomics: combines data about enzymatic activity of numerous numerous post-translational modification proteins in an integrated model which provides dynamic characterization of the current state of an organism. In this project information about numerous proteases, kinases, phosphatases and glycosidases will be collected and used to complement the existing phenotype information.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases will be collected at each participating centre. Every effort will be made to accumulate a well phenotyped cohort of patients with persistent CLBP, sub-grouped into 6 categories: discogenic pain, spinal stenosis (congenital or acquired), facet joint pain, sacroiliac joint pain, low back pain with radicular pain (not predominant radicular pain) and widespread low back pain. Controls (patients without chronic/persistent pain as defined above) will be retrieved from 2 different sources: Existing biobanks of healthy subjects which have collected information about chronic/persistent back pain. Subjects from the companion prospective study on acute LBP who will not have developed CLBP. Age (decades) and gender distribution of controls will be similar to cases.
Key inclusion criteria (8 listed)
- 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
- age: older than 18;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GENETIC OUTCOME
Time frame: 30 months
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.
2 secondary outcomes
GLYCOMIC AND ACTIVOMIC OUTCOME
Time frame: 30 months
STRATIFICATION OF OUR POPULATION
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Derived from this study: PubMed 27798002Allegri M, De Gregori M, Minella CE, Klersy C, Wang W, Sim M, Gieger C, Manz J, Pemberton IK, MacDougall J, Williams FM, Van Zundert J, Buyse K, Lauc G, Gudelj I, Primorac D, Skelin A, Aulchenko YS, Karssen LC, Kapural L, Rauck R, Fanelli G; PainOMICS Group. 'Omics' biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study. BMJ Open. 2016 Oct 19;6(10):e012070. doi: 10.1136/bmjopen-2016-012070.
Related trials for Persistent/Chronic Low Back Pain
Not yet recruitingObservational study
SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain
RecruitingObservational study
GLA:D Back Canada - a Program for Chronic and Persistent Low Back Pain
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MASSIMO ALLEGRI, MD principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent/Chronic Low Back Pain, run by University of Parma at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, United States, Australia, Belgium, Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GENETIC OUTCOME (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02037789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.