Cordotomy for Refractory Cancer Pain

Summary

The goal of this clinical research study is to learn if a cordotomy reduces pain in patients with unmanageable cancer pain. A cordotomy is a procedure, guided by computed tomography (CT) scans, that is performed on the spinal cord and is designed to reduce pain transmission.

Conditions

• Advanced Cancers
• Pain

Interventions

PROCEDURE

Cordotomy

Radiologist performs a spinal tap to inject a contrast drug into the spinal fluid. A 20G spinal needle guided by real-time CT scan to the C1-C2 level opposite to participant's pain. A radiofrequency electrode inserted through the spinal needle into the spinal cord, to the anatomic location of the spinothalamic tract. Once ideal position of the electrode is confirmed, 1 or 2 radiofrequency ablations performed at 70C-80C for 60 seconds. The procedure will take 1-2 hours.

BEHAVIORAL

Pain/Symptom Questionnaire

Pain and symptom questionnaire completed at baseline, by phone during first week of study, and once each month by phone during 6 month follow up.

PROCEDURE

Sharpness Sensory Testing

Sharpness detection determined using 8, 10, 16, 20, 32, 64, and 128g weighted needle devices. Each stimulus applied for about 1 second in ascending order. Participants asked to rate each stimulus as producing the sensation of touch, pressure, sharp, or pain. The sharpness detection threshold defined as the mean force of the stimuli deemed ''sharp'' or ''painful'' from 3 trials separated by an average interval of 30 to 90 seconds.

PROCEDURE

Heat Pain Sensory Testing

Thermal ramps will applied using a 3.6 x 3.6 cm Peltier thermode (Medoc Inc.) from a baseline temperature set at 32C. Skin heated at a rate of 0.30C/s, and participants asked to signal when the stimulus is perceived as first becoming warmer and then painfully hot.

Sponsors & Collaborators

• American Cancer Society, Inc.

  collaborator OTHER

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Ashwin Viswanathan, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-10

Primary Completion

2020-02-25

Completion

2020-02-25

Countries

• United States

Study Locations