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

NCT06746103 | Not Yet Recruiting

• 1 other identifier: RELIEVE
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Spinal Metastasis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline and 3 months

Secondary Outcomes (33)

• Patient Reported Outcome Measure: Michigan Body Map measuring pain location

  Baseline, 1 month, 3 months, and 6 months

• Patient Reported Outcome Measure: PainDETECT measuring neuropathic pain

  Baseline, 1 month, 3 months, and 6 months.

• Patient Reported Outcome Measure: BAT measuring breakthrough pain

  Baseline, 1 month, 3 months, and 6 months.

• Patient Reported Outcome Measure: PROMIS Bank v1.0-Fatigue measuring fatigue

  Baseline, 1 month, 3 months, and 6 months.

• Patient Reported Outcome Measure: PROMIS Bank v2.0-Physical Function measuring physical function

  Baseline, 1 month, 3 months, and 6 months.

Interventions

Surgery PROCEDURE

Surgery may be instrumented stabilization surgery alone, instrumented stabilization and decompression, or decompression surgery alone.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with metastatic spinal tumors as per eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Cement augmentation, vertebroplasty, kyphoplasty, and other emerging interventions such as local ablative technique
• Chemotherapy or systemic therapy alone

Sponsors & Collaborators

• AO Foundation, AO Spine: lead

MeSH Terms

Interventions

Surgical Procedures, Operative

Central Study Contacts

Janneke Loomans

CONTACT

0798746348; janneke.loomans@aofoundation.org

Felix Thomas

CONTACT

felix.thomas@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 24, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-12