A Prospective Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain

NCT02037763 | Unknown DMC

• 1 other identifier: Pain-OMICS PRT
• Study Type: observational
• Target: 5,000
• Locations: 6 countries
• Sites: 7

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).

Conditions

Acute Low Back Pain; Chronic Low Back Pain

Keywords

Low back pain; GWAS; Glycomics; Activomics; Epigenetics

Outcome Measures

Primary Outcomes (1)

• 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.

  54 months

Secondary Outcomes (6)

• Glycomic and Activomic outcome

  54 months

• Epigenetic outcome

  54 months

• Next-generation sequencing outcome

  54 months

• Stratification based on pain characteristics

  54 months

• Stratification based on pain pathophysiology

  54 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Parma: lead
• GENOS: collaborator
• Ip Research Consulting Sasu: collaborator
• Helmholtz Zentrum München: collaborator
• YURII AULCHENKO: collaborator
• King's College London: collaborator

Study Sites (7)

The Center for Clinical Research (CPI)

Winston-Salem, North Carolina, United States

RECRUITING

Edith Cowan University (ECU)

Perth, Australia

RECRUITING

Multidisciplinary Pain Centre, Hospital Oost-Limburg (ZOL)

Genk, Belgium

RECRUITING

"St.Catharine" Orthopedics, Surgery, Neurology and Physical Medicine and Rehabilitation Specialty Hospital (St-Cat)

Zabok, Croatia

RECRUITING

Anesthesia and Pain Therapy Department, Università degli Studi di Parma (UNIPR)

Parma, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo (OSM)

Pavia, 27100, Italy

RECRUITING

King's College London (KCL)

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be collected at recruitment in all enrolled patients. Blood samples will be collected also at the 3 months and 6 months follow up visits in patients who will develop CLBP after the episode of acute LBP.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MASSIMO ALLEGRI, MD

  Pain Therapy Service Azienda Ospedaliera Universitaria Parma Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MASSIMO ALLEGRI, MD

CONTACT

mallegri@parmanesthesia.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

BE (1); GB (1); IT (2); AU (1); US (1); CR (1)