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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Usual Care: The pharmacological treatment will be individualised according to pain intensity, contraindications and the appearance of adverse effects.

Study 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.

Eligibility

Primary outcome measure(s)

• Pain Intensity. Changes from baseline to 6 months. — Baseline, 3 months, 6 months
  Participants will be asked to rate their pain intensity on a horizontal 100-mm Visual Analogue Scale (VAS), ranging from 0 = no pain to 100 = worst imaginable pain. The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in low back pain patients. For patients with subacute or chronic low back pain, the minimum clinically relevant change is considered to be at least 20 mm on a VAS.
• Health-related quality of life. Changes from baseline to 6 months. — Baseline, 3 months, 6 months
  The spanish version of the Euro Quality of Life 5D-5L (EQ-5D-5L) was used to assess the health related quality of life (HRQL).(10) The EQ-5D-5L consists in two pages: the first one is based on a descriptive system that defines health in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories: no problems, slight problems, moderate problems, severe problems, extreme problems.(10) A health state is composed by taking one level for each dimension, and a preference-based scoring function is used to convert the descriptive system to a summary index score (ranging from states worse than dead \<0 to full health 1).

Trial sites (2)

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