Back pain - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

University of Parma

Recruitment countries:

Australia, Belgium, Croatia, Italy, United Kingdom, United States

Health condition studied:

Acute Low Back Pain

URL:

Link to the clinical trial website

About the trial

Interventions:

Key inclusion and exclusion criteria:

• 
  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
  
  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;
  

• Age minimum: 18 Years
• Age maximum: 99 Years
• Gender: Both

Primary outcomes:

Genetic outcome

Secondary outcomes:

Epigenetic outcome
Glycomic and Activomic outcome
Next-generation sequencing outcome
Stratification based on 6 months follow-up
Stratification based on pain characteristics
Stratification based on pain pathophysiology

Target sample size:

5000

Study type:

Observational

Study design:

Observational Model: Cohort, Time Perspective: Prospective

Contacts:

• Name: CRISTINA E MINELLA, MD
• Address:
• Phone:
• Email: c.minella@smatteo.pv.it
• Affiliation:

• Name: MASSIMO ALLEGRI, MD
• Address:
• Phone:
• Email:
• Affiliation: Pain Therapy Service Azienda Ospedaliera Universitaria Parma Italy

• Name: MASSIMO ALLEGRI, MD
• Address:
• Phone:
• Email: mallegri@parmanesthesia.com
• Affiliation:

Technical details

Scientific title:

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

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

GENOS DOO
Helmholtz Zentrum München
Ip Research Consulting Sasu
King's College London
YURII AULCHENKO

Main ID:

NCT02037763

Secondary ID:

Pain-OMICS PRT

Register:

ClinicalTrials.gov

Date of registration:

14/01/2025

Date of first enrollment:

December 2014

Last refreshed:

3 October 2024