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

University of Barcelona

Status: Enrolling

Conditions: Chronic Low-back Pain; Back Pain; Chronic Low-back Pain (cLBP)

Treatments: Drug: Usual Care; Behavioral: Multidisciplinary and multimodal intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06679205

HCB/2024/0791

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age.
• Patients with primary chronic low back pain (non-specific 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.
• Be agreeable to receiving active, non-pharmacological and non-surgical treatment.

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, 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

62 participants in 2 patient groups

Pharmacological control

Active Comparator group

Description:

The subjects in the control group will be treated following a pharmacological approach according to the latest clinical guidelines for patients with chronic low back pain. Thus, the pharmacological options to be considered in each patient will be those included in the first and second analgesic steps of the WHO (preferably without including minor opioids).

Treatment:

Drug: Usual Care

PAINDOC program

Experimental group

Description:

The PAINDOC Program is a multidisciplinary treatment that integrates four parts provided by different health professionals and consists of 7 sessions carried out in the pain unit of the Hospital Clinic of Barcelona over 2 months. It consists of a therapeutic education session (Empowered Relief®) given by a physician from the unit, a pain psychology session given by a psychologist, and 2 pain neuroscience education sessions and 3 therapeutic exercise sessions given by a physiotherapist. This program is already part of the pain unit's routine care practice, so it is considered that the sessions of this program do not represent an additional and specific visit for the patients.

Treatment:

Behavioral: Multidisciplinary and multimodal intervention