Chronic Non-cancer Pain

This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1): A Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 44 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.

This multicenter pilot study evaluates the feasibility, implementation fidelity, and preliminary effects of the GAP-421 (Personalized Care Management) model for chronic pain management in primary care physiotherapy. The GAP model is a time-limited organizational modality that reconfigures schedules, resources, and professional roles during a defined 6-week window to organize care around the individual patient and their trajectory, formalizing coordination work that previously occurred informally. The study uses a convergent mixed-methods design across three primary care health centers in the Southeast Healthcare District (DASE) of the Community of Madrid, Spain. The quantitative component is a prospective multicenter pre-post case series with 3-month follow-up (n=66 patients, 22 per center). The qualitative component includes semi-structured interviews (n=12) and focus groups (3 groups, n=6 each). Integration occurs through Joint Display, Pillar Integration Process, and a 9-type legitimation framework. The primary outcome is patient-perceived care coordination measured on a 0-10 numerical scale (PREM). Secondary outcomes span five domains: patient-reported outcomes (EQ-5D-5L, Graded Chronic Pain Scale, pain intensity), professional outcomes (coordination burden, role clarity), system sustainability (avoidable re-consultations, emergency department use), implementation fidelity, and feasibility indicators. Results will generate feasibility parameters, intraclass correlation coefficient estimates, and process indicators essential for designing definitive cluster-randomized trials testing organizational interventions in primary care physiotherapy.

Pain and sleep are closely linked physiological processes that support overall health and functioning. Increasing evidence shows a dynamic, bidirectional relationship: poor sleep increases pain sensitivity, while chronic pain disrupts normal sleep. Both conditions are highly prevalent and significantly impair quality of life, making them major public health concerns. Chronic pain, defined as pain lasting more than three months, affects around 17% of adults in Spain. Insomnia, though common, is harder to define due to its overlap with medical and psychiatric conditions. It may present as a symptom, a syndrome, or a formal sleep disorder, leading to variability in prevalence estimates. Current diagnostic criteria, including DSM-5 and the International Classification of Sleep Disorders, Third Edition (ICSD-3), adopt the unified concept of chronic insomnia disorder, defined as persistent difficulty with sleep initiation, maintenance, or quality, despite adequate opportunity for sleep, and associated with daytime impairment. ICSD-3 distinguishes three types of insomnia: * Chronic insomnia disorder: symptoms ≥3 times/week for ≥3 months; * Short-term insomnia disorder: symptoms lasting less than 3 months; * Other insomnia disorder: symptoms not meeting criteria for the above. About one-third of the general population reports insomnia symptoms. However, when both night symptoms and daytime impact are considered, the prevalence of chronic insomnia disorder is estimated at 6-10%. Women are more frequently affected, with a female-to-male ratio of about 1.4:1. Despite this, few studies have assessed insomnia specifically in people with chronic non-cancer pain. This gap is important, as untreated insomnia may worsen pain and reduce treatment efficacy, reinforcing a vicious cycle. This observational study (PainSomnia) aims to estimate the prevalence of chronic insomnia among adults with chronic non-cancer pain. The results will help support integrated, individualized treatment approaches that address both sleep and pain in this high-risk population.