Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona

  collaborator OTHER

• University of Barcelona

  lead OTHER

Principal Investigators

• Marc Terradas-Monllor, PhD · University of Vic

• Christian Dürsteler, PhD · University of Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-14

Primary Completion

2026-01-31

Completion

2026-03-31

Countries

• Spain

Study Locations