RELIEVE: Research on Effectiveness of Surgery and Radiotherapy on Relieving Spine Tumor Pain in Patients with Vertebral Metastases

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAO Foundation, AO Spine

About this trial

This is a prospective, multicenter, observational study focusing on assessing and managing pain in patients with metastatic spinal tumors. Pain from spinal metastases adversely impacts quality of life, function, and treatment outcomes. Advances in surgical techniques have shown significant benefits. However, previous studies either lacked nuanced differentiations or simply categorized pain as mechanical or non-mechanical; explaining the highly variable pain outcome measurements in these studies. This study employs the AO Spine Cancer-Related Pain Classification to better categorize neoplastic spinal pain by etiology.

Eligibility criteria

Qualifiers

Age 18 years and older

Patients diagnosed with metastatic spinal tumors with one index metastatic site that, confirmed by the treating clinicians, is causing spine pain

Patients experience at least one type of pain that is of interest of this study, namely, axial non-triggered pain, axial triggered/mechanical pain, radicular non-triggered pain, and radicular triggered/mechanical pain

At least one type of the pain experienced has an NRS > 4 of 10

Disqualifiers

Estimated survival < 3 months

Patients with more than one symptomatic spine metastasis site

Patients with other sources of pain that may confound the measurement of the primary outcome

Patients undergoing the following treatments alone without the surgeries listed in the inclusion criteria or radiotherapy

Trial design

Treatments tested in this trial

  • Surgery

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators