NCT06679205

Effectiveness of a Multidisciplinary Treatment for Patients With 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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Despite improving pharmacological and surgical medical treatment options, chronic low back pain is the most frequent pain disorder and a leading cause of disability. Over the past decades, clinicians have acknowledged that a broader view of disease and disability is needed in chronic conditions treatment. Therefore, biological, psychological and social factors must be addressed to improve such conditions.

Conditions

• Chronic Low-back Pain (cLBP)
• Chronic Low-back Pain
• Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Multidisciplinary and multimodal intervention	The PAINDOC Program consists in: * Therapeutic education: The therapeutic education block consists of 2 parts: a 2-hour education session called Empowered Relief® and 2 1-hour pain neuroscience education sessions. * Psychotherapy: The psychotherapy part consists of 1 group session of 1 hour, face-to-face and with groups of up to 15 people. * Therapeutic exercise: The therapeutic exercise module consists of 3 sessions of 1 hour each, face-to-face, with small groups of between 6 and 10 patients, and given by the physiotherapist of the pain unit.
DRUG	Usual Care	The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.

Timeline

• Start date: 2025-01-14
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2024-11-07
• Last updated: 2025-03-30

Locations

2 sites across 1 country: Spain