Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians.
Amir Qaseem, Timothy J Wilt, Robert M McLean...
https://pubmed.ncbi.nlm.nih.gov/28192789Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06679205
Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain (PAINDOC Protocol): Randomized, Parallel-group, Two-arm, Single-blind Clinical Trial
Led by University of Barcelona · Updated on 2025-03-30
62
Participants Needed
2
Research Sites
8 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
Researchers are evaluating the effectiveness of the PAINDOC multidisciplinary treatment program for people with chronic low back pain. This program combines education about pain neuroscience, therapeutic education (Empowered Relief ), cognitive-behavioral psychotherapy, and therapeutic exercise. The study aims to compare this approach with usual pharmacological care to see if it reduces pain intensity and improves quality of life and other pain-related outcomes. Participants will be randomly assigned to either the usual care group, which follows pharmacological guidelines including the first and second analgesic steps of the WHO, or to the PAINDOC program group. The PAINDOC program includes seven sessions over two months: one session of Empowered Relief therapeutic education, two pain neuroscience education sessions, one pain psychology session, and three therapeutic exercise sessions. These sessions are provided by health professionals at the Hospital Clinic of Barcelona's pain unit. During the study, participants will complete written questionnaires before starting treatment, and at three and six months after treatment begins. Researchers will measure changes in pain intensity, quality of life, pain-related disability, pain catastrophizing, social support, self-efficacy, and medication use. The study will monitor these outcomes to assess the program's effectiveness over six months.
CONDITIONS
Brief Title
Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Patients with primary 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
- Agreeable to receiving active, non-pharmacological and non-surgical treatment
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 months
Participants receive either a multidisciplinary program consisting of therapeutic education, psychotherapy, and therapeutic exercise sessions over 2 months, or individualized pharmacological treatment according to clinical guidelines.
7 sessions over 2 months for the multidisciplinary group; pharmacological treatment with individualized visits as per routine care for the control group
Follow-up
Duration - 6 months from baseline
Participants are assessed for pain intensity, quality of life, and other outcomes at baseline, 3 months, and 6 months from the start of the trial.
3 visits (baseline, 3 months, 6 months)
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
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Research Team
A
Anna Dalmau-Roig, MD
M
Marc Terradas-Monllor, PhD
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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Published Research Related To This Trial
Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial.
Gema Bodes Pardo, Enrique Lluch Girbés, Nathalie A Roussel...
https://pubmed.ncbi.nlm.nih.gov/29138049Low back pain.
Johan W S Vlaeyen, Chris G Maher, Katja Wiech...
https://pubmed.ncbi.nlm.nih.gov/30546064Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.
Beth D Darnall, Anuradha Roy, Abby L Chen...
https://pubmed.ncbi.nlm.nih.gov/34398206Acceptability of multimodal and multidisciplinary group-based program for chronic low back pain: a qualitative study.
Mirari Ochandorena-Acha, Anna Dalmau-Roig, Christian Dürsteler...
https://pubmed.ncbi.nlm.nih.gov/38994708Chronic pain: an update on burden, best practices, and new advances.
Steven P Cohen, Lene Vase, William M Hooten
https://pubmed.ncbi.nlm.nih.gov/34062143