Chronic Low Back Pain: TOTALSPINE - UO04

Launched by IRCCS CENTRO NEUROLESI BONINO PULEJO · Mar 25, 2025

Keywords

ClinConnect Summary

The TOTALSPINE trial is studying chronic low back pain (CLBP) to better understand how different factors can affect a person's health and well-being. The researchers want to look at not just the physical pain but also mental and emotional aspects, like anxiety and depression, which might make the pain worse. They will involve at least 86 participants aged 18 to 65 who have ongoing back pain related to their spinal discs. To join, participants need to have a pain level of over 4 on a scale from 0 to 10 and must not have certain serious medical conditions or have received recent treatments like physical therapy.

Participants will go through assessments at the start of the study and then again after one, two, and six months. This will help the researchers track any changes in their condition and understand how different challenges can impact recovery. By gathering this information, the study aims to create tailored support to help people manage their chronic low back pain more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 65 years;
• • CLBP of discogenic origin rated above 4 on the Numeric Rating Scale (NRS) in the 2 weeks prior, ongoing for the last 6 weeks up to 12 months before inclusion
• Exclusion Criteria:
• • Past or present medical history of "red flags" (e.g., cancer, fractures, infections) or specific causes of non-discogenic LBP; 2) Having received physical therapy for LBP in the last 6 months;
• • Previous spinal surgery;
• • Severe or progressive neurological deficits;
• • Any serious medical comorbidity that, in the opinion of the Principal Investigator (PI), would make participation unsafe or impossible