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

Launched by AO FOUNDATION, AO SPINE · Dec 17, 2024

Keywords

ClinConnect Summary

The RELIEVE trial is a study designed to understand how surgery and radiotherapy can help relieve pain for patients suffering from spinal tumors caused by cancer that has spread to the spine, known as spinal metastasis. Many patients with these tumors experience significant pain, which can greatly affect their daily lives and overall well-being. This study aims to better categorize and understand different types of pain associated with spinal tumors to improve treatment outcomes.

To participate in this trial, you need to be at least 18 years old and have been diagnosed with a spinal tumor that is causing you pain. You should also experience specific types of pain that can be measured, and your pain should be rated at a level of 4 or higher on a scale of 0 to 10. The study is looking for patients who will undergo surgery or radiotherapy as part of their treatment. However, if you have multiple areas of spinal tumors or other pain conditions that might complicate the study, you may not be eligible. As the trial is not yet recruiting, details about participation and expectations will be provided once it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Patients undergoing surgery and/or radiotherapy
• • Surgery may be instrumented stabilization surgery alone, instrumented stabilization and decompression, or decompression surgery alone.
• • Percutaneous screw fixation counts as instrumented stabilization surgery.
• • Any kind of radiotherapy is includable.
• • Ability to provide informed consent according to the IRB/EC defined and approved procedures
• Exclusion Criteria:
• • Estimated survival \< 3 months
• • Patients with more than one symptomatic spine metastasis site
• • o An example is a patient with two metastasis sites: a lumbar metastasis (causing vertebral fracture and epidural compression leading to mechanical lower back pain and static radicular pain to legs) and a cervical metastasis (causing tumor-related pain at the neck).
• • Patients with other sources of pain that may confound the measurement of the primary outcome
• • o An example is a patient with liver metastasis which causes visceral pain that can confound the thoracic spinal pain caused by the spinal metastasis.
• • Patients undergoing the following treatments alone without the surgeries listed in the inclusion criteria or radiotherapy
• • Cement augmentation, vertebroplasty, kyphoplasty, and other emerging interventions such as local ablative technique
• • Chemotherapy or systemic therapy alone