NCT06746103

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: AO Foundation, AO Spine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, multicenter, observational study. Patients with metastatic spinal tumors and one symptomatic metastatic site (ie, the index metastasis) that is causing at least one type of pain (ie, the index pain) of interest to this study that has at least "moderate" pain in intensity (numeric rating scale \[NRS\] \> 4) will be enrolled from participating sites. Four types of neoplastic pain in the AO Spine Cancer-Related Pain Classification are of interest to this study. 1. The axial non-triggered pain is hypothesized to be secondary to periosteal stretching and/or release of nociceptive cytokines; it is mostly associated with osteoclastic activity but can be sometimes associated with reactive sclerosis. This pain may show a diurnal variation with increased severity at night and typically responds to steroids or opioid medications. 2. The axial triggered/mechanical pain is nociceptive pain secondary to inability of osseous spinal structures to support physical loads. It is typically associated with osteoclastic activity but can also be due to periosteal nerve stimulation from frank fractures or microfractures. This pain typically does not respond well to the medical treatments and if the pain is severe, progressive, or debilitating, may benefit from stabilization. 3. Radicular non-triggered pain is a result of persistent compression of a nerve root which can be due to tumor or bone expansion. This type of neurologic pain follows a specific nerve root distribution with a correlative compression lesion. It may be resolved with decompression or potentially with nonoperative measures such as radiotherapy or systemic treatments. 4. Radicular triggered/mechanical pain is a result of transient compression of a nerve root caused by mechanical instability. This type of neurologic pain also follows a specific nerve root distribution with a correlative compression lesion. It may be relieved in certain position such as recumbency and often benefits from stabilization surgery with or without decompression. Patients will be treated (ie, the index treatment) with surgery alone, surgery with postoperative radiotherapy, or radiotherapy alone for the index metastasis. Day 0 is defined as: 1) for patients receiving surgery only, the day of the surgery (or the first stage of surgery in the case of staged surgery), 2) for patients receiving radiotherapy only, the day of the first session of radiotherapy, or 3) for patients receiving both surgery and radiotherapy, whichever treatment day that comes earlier. Patients will be followed up at 1 month, 3 months, and 6 months after Day 0. The primary study outcome is the intensity of the four different types of pain caused by the index spinal metastasis. The study will delineate how these kinds of pain respond to treatment over time. Secondary objectives investigate factors predictive of pain relief and the relationship between pain and other patient-reported outcomes (PROs).

Conditions

• Spinal Metastasis

Interventions

Type	Name	Description
PROCEDURE	Surgery	Surgery may be instrumented stabilization surgery alone, instrumented stabilization and decompression, or decompression surgery alone.

Timeline

• Start date: 2025-03-31
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2024-12-24
• Last updated: 2024-12-24