Clinical trial NCT06679205: Effectiveness of a Multidisciplinary Treatment for Patients With Chronic Low Back Pain
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain (cLBP)
Chronic Low-back Pain
Back Pain
Keywords: chronic low-back pain
chronic pain
pain catastrophizing
multidisciplinary treatment
therapeutic exercice
pain neuroscience education
cognitive behavioural therapy
therapeutic education
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2024-11-07
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity. Changes from baseline to 6 months.
timeFrame: Baseline, 3 months, 6 months
measure: Health-related quality of life. Changes from baseline to 6 months.
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Pain-related Disability. Changes from baseline to 6 months.
timeFrame: Baseline, 3 months, 6 months
measure: Pain Catastrophizing. Changes from baseline to 6 months.
timeFrame: Baseline, 3 months, 6 months
measure: Perceived Social Support. Changes from baseline to 6 months.
timeFrame: Baseline, 3 months, 6 months
measure: Self-efficacy. Changes from baseline to 6 months.
timeFrame: Baseline, 3 months, 6 months
measure: Consumption of analgesic, anti-inflammatory and coadjuvant analgesic drugs
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: University of Vic
name: Marc Terradas-Monllor, PhD
role: STUDY_DIRECTOR
affiliation: University of Barcelona
name: Christian Dürsteler, PhD
role: STUDY_DIRECTOR
References:
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citation: Ochandorena-Acha M, Dalmau-Roig A, Dursteler C, Vilchez-Oya F, Ferrer A, Martin-Villalba I, Obach A, Terradas-Monllor M. Acceptability of multimodal and multidisciplinary group-based program for chronic low back pain: a qualitative study. Physiother Theory Pract. 2025 May;41(5):981-997. doi: 10.1080/09593985.2024.2377343. Epub 2024 Jul 12.
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