Acute Low Back PainNCT02037763
A Prospective Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain
An observational study of Acute Low Back Pain and Chronic Low Back Pain, run by University of Parma at 7 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Low Back Pain, Chronic Low Back Pain
- How many people
- 5,000 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Dec 2014to Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Each clinical centre will identify patients with an episode of acute LBP, with or without irradiation, referred from primary care physicians, orthopaedic specialists or directly selected in the emergency room (accessing hospital for acute low back pain). The enrolment will be competitive among the participating clinical centres.
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
7 sites in 6 countries.
MASSIMO ALLEGRI, MD contact
7 sites in 6 countries
Italy2 sites, 2 recruiting
- Recruiting
Anesthesia and Pain Therapy Department, Università degli Studi di Parma (UNIPR)
Parma
GUIDO FANELLI, PROF
- Recruiting
Fondazione IRCCS Policlinico San Matteo (OSM)
Pavia, 27100
CRISTINA E MINELLA, MD, c.minella@smatteo.pv.it
CRISTINA E MINELLA, MD
United States1 site, 1 recruiting
- Recruiting
The Center for Clinical Research (CPI)
Winston-Salem, North Carolina
LEONARDO KAPURAL, MD
Australia1 site, 1 recruiting
- Recruiting
Edith Cowan University (ECU)
Perth
WEI WANG, PROF
Belgium1 site, 1 recruiting
- Recruiting
Multidisciplinary Pain Centre, Hospital Oost-Limburg (ZOL)
Genk
JAN VAN ZUNDERT, MD
Croatia1 site, 1 recruiting
- Recruiting
"St.Catharine" Orthopedics, Surgery, Neurology and Physical Medicine and Rehabilitation Specialty Hospital (St-Cat)
Zabok
DRAGAN PRIMORAC, PROF
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London (KCL)
London
FRANCES WILLIAMS, MD
About this study
Official title: A Prospective Controlled Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain
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).
Read the detailed description
Investigators will link and relate clinical data to a multiple "omics" analysis 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.
"OMIC" biomarkers investigated will be genetics, epigenetics, glycomics and activomic.
Genetics through genome wide association studies (GWAS) 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.
Epigenetic regulation is a universal tool that higher organisms use to adapt to changes in the environment. While environmental factors, such as diet influence enzymatic processes only while they are directly present, their prolonged effects can be achieved through the cell memory of epigenetic marks. Various elements of the membrane signal transduction system were reported to be regulated by epigenetic mechanisms.
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.
"Omics" data will be compared stratifying population according to pain characteristics, pain intensity, response to treatment and duration of pain. In a subgroup of patients, "omics" data will be compared stratifying 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.
- Conditions
- Acute Low Back Pain, Chronic Low Back Pain
- Keywords
- Low back pain, GWAS, Glycomics, Activomics, Epigenetics
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic outcome
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.
Measured: 54 months
Secondary outcomes (6)
Glycomic and Activomic outcome
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.
Measured: 54 months
Epigenetic outcome
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.
Measured: 54 months
Next-generation sequencing outcome
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.
Measured: 54 months
Stratification based on pain characteristics
"Omics" data will be compared stratifying our population according to pain characteristics, pain intensity, response to treatment and duration of pain.
Measured: 54 months
Stratification based on pain pathophysiology
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.
Measured: 54 months
Stratification based on 6 months follow-up
"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.
Measured: 54 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 startDec 2014
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
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, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- MASSIMO ALLEGRI, MD, Principal investigator, Pain Therapy Service Azienda Ospedaliera Universitaria Parma Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037763
- Sponsor's protocol ID
- Pain-OMICS PRT
- Status last verified
- Sep 2016
- First submitted
- 14 Jan 2014
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 Prospective Controlled Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02037763
- Acronym / sponsor ID
- Pain-OMICS PRT
- Conditions
- Acute Low Back Pain, Chronic Low Back Pain
- Keywords
- Low back pain, GWAS, Glycomics, Activomics, Epigenetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- 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
- Dec 2014
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- 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.
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).
Detailed description
Investigators will link and relate clinical data to a multiple "omics" analysis 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.
"OMIC" biomarkers investigated will be genetics, epigenetics, glycomics and activomic.
Genetics through genome wide association studies (GWAS) 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.
Epigenetic regulation is a universal tool that higher organisms use to adapt to changes in the environment. While environmental factors, such as diet influence enzymatic processes only while they are directly present, their prolonged effects can be achieved through the cell memory of epigenetic marks. Various elements of the membrane signal transduction system were reported to be regulated by epigenetic mechanisms.
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.
"Omics" data will be compared stratifying population according to pain characteristics, pain intensity, response to treatment and duration of pain. In a subgroup of patients, "omics" data will be compared stratifying 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each clinical centre will identify patients with an episode of acute LBP, with or without irradiation, referred from primary care physicians, orthopaedic specialists or directly selected in the emergency room (accessing hospital for acute low back pain). The enrolment will be competitive among the participating clinical centres.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
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: 54 months
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.
6 secondary outcomes
Glycomic and Activomic outcome
Time frame: 54 months
Epigenetic outcome
Time frame: 54 months
Next-generation sequencing outcome
Time frame: 54 months
Stratification based on pain characteristics
Time frame: 54 months
Stratification based on pain pathophysiology
Time frame: 54 months
Stratification based on 6 months follow-up
Time frame: 54 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
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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 contact
MASSIMO ALLEGRI, MD principal investigator
Pain Therapy Service Azienda Ospedaliera Universitaria Parma Italy
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Low Back Pain and Chronic Low Back Pain, run by University of Parma at 7 sites in 6 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 4 inclusion and 6 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: status not confirmed, 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 7 sites in Italy, United States, Australia, Belgium, Croatia and 1 more country. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MASSIMO ALLEGRI, MD (mallegri@parmanesthesia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic outcome (time frame: 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.