Clinical trial · Interventional
Cordotomy for Refractory Cancer Pain
Minimally Invasive Cordotomy for Refractory Cancer Pain
NCT02345629CI-TRIAL-00066960completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cordotomy | Procedure | — | UNRESOLVED |
| Heat Pain Sensory Testing | Procedure | — | UNRESOLVED |
| Pain/Symptom Questionnaire | Behavioral | — | UNRESOLVED |
| Sharpness Sensory Testing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cordotomy Group
- description
- 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. Quantitative sensory testing on day prior to procedure, and on postoperative days number 1 and 7. Pain and symptom questionnaire completed at baseline, over the phone during the first week of study, and at each follow up visit/phone call. Participants undergo quantitative sensory testing on day prior to procedure, and on postoperative days number 1 and 7. Sensory testing to include sharpness and heat detection.
- interventionNames
- Procedure: Cordotomy
- Behavioral: Pain/Symptom Questionnaire
- Procedure: Sharpness Sensory Testing
- Procedure: Heat Pain Sensory Testing
- type
- ACTIVE_COMPARATOR
- label
- Comprehensive Medical Management Group
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with one-sided, somatic pain due to tumor involvement below the shoulder level (C5 dermatome). 2. Patients with refractory cancer pain who are seen by the Supportive Care or Pain Medicine teams, and who either (1) are on appropriate opioid therapy at the time of consultation, or (2) who undergo an initial consultation and at least 2 clinical follow-up evaluations by these services. 3. Patients with a life expectancy greater than 1 month. 4. Patients must be 18 years old or older. 5. Patients must be able to read, speak and understand English or Spanish. Exclusion Criteria: 1\) Patients with significant pulmonary dysfunction, large intracranial metastases, or significant thrombocytopenia (platelet count refractory to transfusion).
References
Publications (0)
Data not yet available
No reference posted for this study.