Resource-Oriented Case Management to Implement Recommendations for Patients With Chronic Pain and Frequent Use of Analgesics (RELIEF) – Study Protocol of a Cluster-Randomized Controlled Trial

BACKGROUND: Chronic non-cancer pain (CNCP) is a frequent reason for consulting a general practitioner. German guidelines underline its biopsychosocial etiology, relevance of self-care and nonpharmacological therapy options, and comprehensive assessment for individualized treatment and monitoring of pain medication use. A case management program was developed in project RELIEF (Resource-oriented case management to implement recommendations for patients with chronic pain and frequent use of analgesics in general practices) to support implementation of pain management guideline recommendations in general practice regarding assessment and monitoring, patient and practice team education, promotion of self-care strategies, and rational pharmacotherapy. OBJECTIVE: The aim is to effectively reduce pain-related disability in patients with chronic non-cancer pain and improve associated outcomes. METHODS: Following the assessment of its feasibility, the program will now be tested in a cluster randomized controlled trial with general practices and adult patients with CNCP, pain-related disability, and analgesics use located in Baden-Württemberg, Germany. The intervention comprises software-supported medical pain history, structured appointments, e-learning for practice teams, educational material for patients, and a toolbox with additional resources. Participating practices will recruit eligible patients via a screening questionnaire. The primary outcome will be measured by the Pain Disability Index German version. Outcome evaluation data will be collected by digitalized questionnaires to be completed by participants. Descriptive statistics will summarize demographics and baseline characteristics. A mixed-methods process evaluation will use digitally provided surveys and telephone interviews to assess intervention mechanisms regarding pain-related self-efficacy, patient activation, medication use, non-pharmacological treatment options, and intervention fidelity. RESULTS: Recruitment takes place between January and April 2026. Targeted maximum sample size is 28 practices and 252 patients. The intervention period will start with completed recruitment. It is expected that eligible patients will benefit from improved medication management, intensified use of nonpharmacological treatment strategies and reduction of pain-related disabilities. CONCLUSIONS: This study will provide valuable information regarding potential effects of the intervention.