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Randomized Controlled Trial
. 2025 Jan 17;26(1):59.
doi: 10.1186/s12891-025-08294-8.

A multidisciplinary pain management program for patients with chronic low back pain: a randomized, single-blind, controlled, feasibility study

Anna Dalmau-Roig  1 , Christian Dürsteler  1   2 , Mirari Ochandorena-Acha  3   4 , Francisco Vilchez-Oya  1 , Inés Martin-Villalba  5 , Amadeu Obach  5 , Marc Terradas-Monllor  6   7   8
Affiliations
Randomized Controlled Trial

A multidisciplinary pain management program for patients with chronic low back pain: a randomized, single-blind, controlled, feasibility study

Anna Dalmau-Roig et al. BMC Musculoskelet Disord. .

Abstract

Background: Multidisciplinary programs are the first recommendation for non-specific chronic low-back pain, but implementing this type of program is complicated to get up and running. The primary aim of this study was to assess the feasibility and appropriateness of the PAINDOC multidisciplinary program for subjects with chronic low-back pain. The secondary objectives were to evaluate the decrease in pain intensity, pain-related disability and pain catastrophizing, as well as the improvement in quality of life with this program. Furthermore, another of the secondary objectives was to calculate the sample size for a future randomized clinical trial.

Methods: This study was conducted in a hospital pain unit using two successive recruitment waves. First, the feasibility outcomes (recruitment, completion, and drop-out rates) of a 5-month non-random prospective cohort (n = 227) were recorded. Then, the clinical outcomes (pain intensity, quality of life, disability, and pain catastrophizing) were recorded from a prospective, controlled, two-armed and single-blind feasibility study (ClinicalTrials.gov, NCT05974072). It included 41 participants that were randomly allocated to either the pharmacological treatment (n = 21) arm or PAINDOC program (n = 20) arm.

Results: The recruitment rate was 66%, with the completion rate standing at 80.7% and the drop-out rate at 19.3%. Significant differences and a medium size effect were observed between groups in terms of pain intensity (p = .017, r = .408) at the 4-month follow-up. The intragroup analysis of the PAINDOC group revealed significant lessening in pain intensity (p = < 0.001) and improvements in quality of life (p = .030).

Conclusions: This study showed that the PAINDOC multidisciplinary program is a feasible treatment for patients with non-specific chronic low-back pain. Furthermore, the exploratory results of this study suggest that it could be an effective treatment to reduce pain intensity and improve on self-reported quality of life in these patients, although a future randomized clinical trial is needed to determine its effectiveness.

Trial registration: NCT05974072 (registration date July 11, 2023; retrospectively registered; ClinicalTrials.gov).

Keywords: Chronic pain; Low back pain; Multidisciplinary approach; Multimodal treatment; Pain management.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study protocol was approved by the Research Ethics Committee of the Hospital Clínic de Barcelona (HCB/2023/0177). All patients included in this trial gave written informed consent to participate. This clinical trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines (ICH E6 R2). Patient confidentiality was guaranteed in accordance with current Spanish legislation (LOPD 3/2018). No human tissue samples were collected, used, or stored in this clinical trial. Consent for publication: Not applicable. This manuscript does not contain information or images that could lead to the identification of a study participant. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Schedule of the PAINDOC program
Fig. 2
Fig. 2
Flow chart diagram of patients throughout the course of the study
See this image and copyright information in PMC

References

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