Management of Chronic Non-Cancer Pain Through a Multicomponent Workshop Based on Non-Pharmacological Therapies: A Protocol for a Mixed-Methods Study, Including a Two-Arm Parallel-Group Randomized Clinical Trial and a Qualitative Component.

Background/

Objectives

Chronic non-cancer pain often requires approaches beyond pharmacological treatment. This protocol describes a mixed-methods study evaluating the effectiveness of a multicomponent intervention based on non-pharmacological therapies (NPhTs) and exploring participants' post-intervention experience.

Methods

The design includes a randomized, controlled, two-arm parallel-group clinical trial with 1:1 allocation, embedded within a mixed-methods approach that includes a qualitative phenomenological strand. This study will be conducted at Hospital San Juan de Dios del Aljarafe, Spain. A total of 160 adults with chronic non-cancer pain will be randomly assigned to the intervention or control group. The intervention group will receive five weekly 3.5 h face-to-face sessions combining pain education, emotional regulation, cognitive-motivational and mind-body techniques, lifestyle recommendations, peer support, and home practice, supported by a mobile application. The control group will continue usual care, without the workshop or intervention-related app content. The primary outcome will be change in the EuroQol-5D (EQ-5D) index from baseline to 1 month. Secondary outcomes will include the EQ-5D visual analogue scale (VAS) score, pain intensity, well-being, self-esteem, resilience, anxiety and depression, pain catastrophizing, medication use, and healthcare resource use. Outcomes will also be assessed at 4 months and, in the intervention group, at 7 months. Semi-structured interviews will explore the participants' experiences, perceived usefulness of the techniques, and barriers and facilitators to maintaining the strategies learned.

Conclusions

This protocol will evaluate the effectiveness and acceptability of a structured group-based NPhT intervention for chronic non-cancer pain. The findings may inform its applicability to person-centered and self-care-oriented models of care. Trial registration: ClinicalTrials.gov NCT06440668.