Multidisciplinary treatment for chronic low back pain
Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain (PAINDOC Protocol): Randomized, Parallel-group, Two-arm, Single-blind Clinical Trial (PAINDOC Project)
This study is testing a new program that combines education, therapy, and exercise to see if it can help people with chronic low back pain feel better and improve their quality of life compared to regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Barcelona Academic / other |
| Locations | 2 sites (Barcelona, Barcelona and 1 other locations) |
| Trial ID | NCT06679205 on ClinicalTrials.gov |
What this trial studies
The PAINDOC program combines four effective disciplines to treat chronic low back pain: education in pain neuroscience, therapeutic education, cognitive-behavioral psychotherapy, and therapeutic exercise. This interventional study aims to assess the effectiveness of this multidisciplinary approach in reducing pain intensity and enhancing quality of life compared to standard care. Additionally, it evaluates secondary outcomes such as pain-related disability, pain catastrophizing, social support, self-efficacy, and medication reduction. The program addresses the biological, psychological, and social factors contributing to chronic pain.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with non-specific chronic low back pain experiencing pain at least 50% of the time for the last 6 months.
Not a fit: Patients with inflammatory low back pain, severe mental illness, or significant physical disabilities may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve the quality of life for patients suffering from chronic low back pain.
How similar studies have performed: Previous studies have shown positive outcomes with multidisciplinary approaches for chronic pain management, suggesting this method is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age. * Patients with primary chronic low back pain (non-specific chronic low back pain) of axial predominance. * Experiencing pain at least 50% of the time over the last 6 months. * Average weekly pain intensity equal or greater than 4 out of 10 on a verbal numerical scale. * Be agreeable to receiving active, non-pharmacological and non-surgical treatment. Exclusion Criteria: * Inflammatory low back pain. * History of cancer in the last 5 years. * Unexplained and unintentional weight loss of 10 Kg or more over the preceding 12-month period. * Lack of control of bowel and bladder function (cauda equina). * Difficulty in performing the sessions due to severe physical disability. * Diagnosis of severe mental illness (schizophrenia, major depression, bipolar disorder, etc.). * Strong prescription opioid or parenteral medication addiction disorders. * Technical-logistical problems (inability to attend treatment sessions or inability to fill out assessment questionnaires). * Problems in understanding the content of the sessions (language barrier, severe hearing loss or severe cognitive impairment). * Have sought compensation or entered into litigation in the preceding 12-month period.
Where this trial is running
Barcelona, Barcelona and 1 other locations
- Hospital Clínic de Barcelona — Barcelona, Barcelona, Spain (Not_yet_recruiting)
- Hospital Clínic de Barcelona — Barcelona, Spain, Spain (Recruiting)
Study contacts
- Study coordinator: Anna Dalmau-Roig, MD
- Email: dalmaur@clinic.cat
- Phone: +34 639482849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.