Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors

Conditions

• Lumbar Neoplasm
• Thoracic Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• kyphoplasty with Osteocool — PROCEDURE
  Participants will receive kyphoplasty with Osteocool prior to their Standard of Care External Beam Radiotherapy.

Study Details

This study looks at how well a combination of treatments helps reduce pain in people with tumors in the middle and lower back (thoracic and lumbar spine). All participants receive the same treatment, which includes a procedure to stabilize the spine (kyphoplasty), radiofrequency ablation will be with the Osteocool system and radiation therapy. The goal is to see how effective this combined approach is at relieving pain. The purpose of this study is to find out whether combining these three treatments provides better pain relief for patients with thoracic and lumbar spine tumors. This study is for adults who have cancer that has spread to the thoracic or lumbar spine and who report moderate to severe back pain (a pain score of 5 or higher on a 0-10 pain scale).

Key Dates

Start date

Mar 16, 2026

Status verified

Apr 2026

Primary completion

Mar 1, 2031

Completion

Mar 1, 2031

Study Design

Enrollment

70 participants (estimated)

Arms

• Arm: Metastatic thoracic or lumbar spine tumor
  metastatic thoracic or lumbar spine tumor and reported back pain of ≥ 5 on a visual analog scale (VAS) assessments scale.

Primary Outcome Measure

Change in pain intensity [ Time Frame: Baseline and at 3 months (1 months after completion of radiotherapy) ]

Central Contacts

• Markeela Lipscomb
  919-984-0000
  [email protected]
• Desma Jones
  [email protected]

Locations (1)

Find similar trials in Chapel Hill, NC

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