Interdisciplinary Outpatient Multimodal Pain Treatment After Non-Confirmation of Surgical Indication for Persistent Spinal Pain: Real-World Outcomes in 9,217 Patients (RESPONSE Study)

Study identification

• EU PAS number:
  EUPAS1000000952
• Study ID:
  1000000952
• Official title and acronym:
  Interdisciplinary Outpatient Multimodal Pain Treatment After Non-Confirmation of Surgical Indication for Persistent Spinal Pain: Real-World Outcomes in 9,217 Patients (RESPONSE Study)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Persistent spinal pain is frequently evaluated for surgical treatment, although chronic spinal pain is widely recognized as a complex biopsychosocial condition. Within a structured healthcare program in Germany, patients referred for planned spinal surgery undergo an interdisciplinary second-opinion assessment involving pain medicine, pain psychology, and pain physiotherapy. When surgical indication is not confirmed and significant pain-related disability or advanced pain chronification is present, patients may enter a structured intensive outpatient interdisciplinary multimodal pain treatment program.; ; Our RESPONSE study evaluates real-world outcomes of this outpatient program in patients with persistent spinal pain after non-confirmation of a planned spinal surgery. The analysis is based on routinely collected clinical data from a nationwide network of specialized pain centers between 2014 and 2025.; ; The study population comprises 9,217 consecutive patients who completed the three-week outpatient interdisciplinary multimodal pain treatment program. The primary outcome is change in pain-related disability measured by the modified Pain Disability Index (mPDI). Secondary outcomes include pain intensity, functional capacity, health-related quality of life, psychological distress, fear-avoidance beliefs, pain self-efficacy, and habitual well-being.; ; Patients are stratified according to the Chronic Pain Grading Scale (CPGS). Statistical analyses include paired t-tests for within-group changes and multivariable analyses adjusting for age, sex, and treatment center.; ; The study uses anonymized routine care data and represents a real-world evaluation of interdisciplinary outpatient multimodal pain treatment following interdisciplinary second-opinion assessment prior to spinal surgery.
• Study status:
  Finalised

Research institutions and networks

Institutions

O.Meany-MDPM

Study timelines

Date when funding contract was signed

Planned:30/01/2026

Actual:30/01/2026

Study start date

Planned:01/02/2026

Actual:01/02/2026

Data analysis start date

Planned:01/02/2026

Actual:01/02/2026

Date of final study report

Planned:28/02/2026

Actual:28/02/2026

Sources of funding

No external funding

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable