Actively Recruiting
Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain
Led by University of Barcelona · Updated on 2025-03-30
62
Participants Needed
2
Research Sites
58 weeks
Total Duration
On this page
Sponsors
U
University of Barcelona
Lead Sponsor
H
Hospital Clinic of Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
PAINDOC is a treatment program that includes 4 disciplines that, separately, have demonstrated their effectiveness in the treatment of chronic low back pain: education in pain neuroscience, therapeutic education (Empowered Relief®), psychotherapy based on cognitive-behavioral therapy and therapeutic exercise. The primary objective of the study is to evaluate the effectiveness of the PAINDOC multidisciplinary treatment program in reducing pain intensity and improving quality of life in persons with chronic low back pain referred to the pain unit of the Hospital Clinic of Barcelona, compared to usual care treatment. As secondary objectives, the present study aims to evaluate the effect of the PAINDOC program on: * The reduction of pain-related disability. * The reduction of pain catastrophizing. * The improvement in perceived social support. * The improvement in perceived autonomy (self-efficacy). * The reduction of analgesic, anti-inflammatory and adjuvant analgesic medication. The main questions it aims to answer are: * Is the proposed multidisciplinary treatment effective in improving pain-related outcomes? * Is the proposed multidisciplinary treatment effective in reducing analgesic medication? Participants will receive either usual care (pharmacological control) or the PAINDOC program, which consists of 7 multidisciplinary sessions within 2 months. There will be one therapeutic education session called Empowered Relief®, 2 pain neuroscience education sessions, one pain psychology session and 3 therapeutic education sessions. Besides, participants will be assessed using written questionnaires before treatment, at 3 months and at 6 months. Researchers will assess the effectiveness of the multidisciplinary treatment group comparing both groups to see if there is any difference in several pain-related outcomes.
CONDITIONS
Official Title
Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Primary chronic low back pain of axial predominance
- Pain occurring at least 50% of the time during the past 6 months
- Average weekly pain intensity of 4 or higher on a 10-point scale
- Willingness to receive active, non-pharmacological and non-surgical treatment
You will not qualify if you...
- Inflammatory low back pain
- History of cancer within the last 5 years
- Unexplained weight loss of 10 kg or more in the past 12 months
- Loss of bowel or bladder control (cauda equina syndrome)
- Severe physical disability limiting session participation
- Diagnosis of severe mental illness (e.g., schizophrenia, major depression, bipolar disorder)
- Addiction to strong opioids or parenteral medications
- Inability to attend treatment sessions or complete questionnaires due to technical or logistical issues
- Language barriers, severe hearing loss, or severe cognitive impairment
- Seeking compensation or involved in litigation related to back pain in the past 12 months
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08006
Not Yet Recruiting
2
Hospital Clínic de Barcelona
Barcelona, Spain, Spain, 08036
Actively Recruiting
Research Team
A
Anna Dalmau-Roig, MD
CONTACT
M
Marc Terradas-Monllor, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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