Chronic Low Back Pain: TOTALSPINE - UO04
Launched by IRCCS CENTRO NEUROLESI BONINO PULEJO · Mar 25, 2025
Trial Information
Current as of April 29, 2025
Active, not recruiting
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
About Irccs Centro Neurolesi Bonino Pulejo
IRCCS Centro Neurolesi Bonino Pulejo is a leading research institute in Italy, dedicated to advancing knowledge and treatment in the field of neurological disorders. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), the center emphasizes high-quality clinical research and innovation, focusing on the diagnosis, treatment, and rehabilitation of patients with neurodegenerative diseases and acute neurological conditions. With a multidisciplinary team of experts and state-of-the-art facilities, the institute collaborates with national and international partners to conduct cutting-edge clinical trials aimed at improving patient outcomes and contributing to the global understanding of neurological health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Messina, , Italy
Roma, It, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported