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

Last updated: March 25, 2025
Sponsor: University of Barcelona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

Usual Care

Multidisciplinary and multimodal intervention

Clinical Study ID

NCT06679205
HCB/2024/0791
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years of age.

  • Patients with primary chronic low back pain (non-specific chronic low back pain) ofaxial 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 verbalnumerical scale.

  • Be agreeable to receiving active, non-pharmacological and non-surgical treatment.

Exclusion

Exclusion Criteria:

  • 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, bipolardisorder, etc.).

  • Strong prescription opioid or parenteral medication addiction disorders.

  • Technical-logistical problems (inability to attend treatment sessions or inabilityto fill out assessment questionnaires).

  • Problems in understanding the content of the sessions (language barrier, severehearing loss or severe cognitive impairment).

  • Have sought compensation or entered into litigation in the preceding 12-monthperiod.

Study Design

Total Participants: 62
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase:
Study Start date:
January 14, 2025
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Hospital Clínic de Barcelona

    Barcelona, 08006
    Spain

    Site Not Available

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