Clinical trial · Observational

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

NCT06746103CI-TRIAL-00084034RELIEVEnot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Spinal Metastasis	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Surgery	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Pain intensity on the Brief Pain Inventory Intensity Scale of four different types of pain caused by the index spinal metastasis, measuring pain on a numeric rating scale from 0 to 10, with 0 meaning no pain and 10 meaning as bad as one can imagine.
timeFrame
Baseline and 3 months
description
The primary study outcome is the intensity of the four different types of pain caused by the index spinal metastasis, ie, the index pain(s): * Axial non-triggered pain * Axial triggered/mechanical pain * Radicular non-triggered pain * Radicular triggered/mechanical pain

Secondary outcomes (33)

measure
Patient Reported Outcome Measure: Michigan Body Map measuring pain location
timeFrame
Baseline, 1 month, 3 months, and 6 months
description
The following Patient Reported Outcome Measure will be measured: Michigan body map. The Michigan Body Map is used to record the location and number of painful body regions. At baseline, patients will use the map to indicate the locations of each index pain experienced. At 1 month, 3 months, and 6 months, patients will use the map to indicate any new locations of pain, apart from the locations of the index pain, since the index treatment.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.