N/A
N=8
C-RFA of Residual Limb Neuroma
Phantom Limb Pain · Neuroma Amputation
Bottom Line
View on ClinicalTrials.gov: NCT04538417 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Numeric Rating Scale (NRS) for Pain at 6 Months — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cooled Radiofrequency Ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (NRS) for Pain at 6 Months |
4 | — |
| SECONDARY Median Change in Numeric Rating Scale (NRS) Scores for Pain |
1.0; 2.0; 1.0; 3.0 | — |
| SECONDARY Medication Quantification Scale III Mean Score |
8.3; 6.9; 7.1; 7.1 | — |
| SECONDARY Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC) |
3; 3; 1; 1 | — |
Summary
To assess changes in pain, physical function, and health-related quality of life in patients with post-amputation neuroma-associated residual limb pain after cooled radiofrequency ablation.
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 years of age at day of enrollment.
- Clinical diagnosis lower extremity amputation performed more than 1 year since study enrollment.
- Residual pain described as burning pain and sensations of movement in the affected amputated limb32.
- Pain duration of more than 6 months despite a trial of conservative therapy (medications, physical therapy) for 2 months.
- Ultrasound and / or MRI imaging pathology consistent with clinical symptoms and signs.
- Greater than 50% pain relief with a diagnostic neuroma block
Exclusion Criteria
- Refusal or inability to participate, provide consent, or provide follow-up information for the 12-month duration of the study.
- Contraindications to diagnostic block or treatment ablation (active infection, bleeding disorders, and pregnancy or breastfeeding, active immunosuppression, participation in another phantom or residual limb pain trial within the last 30 days
- Non-neurogenic source of residual or phantom limb pain.
- Active moderate to severe lumbar radiculopathy.
- Any injection in the residual limb within the last 30 days.
- Severe uncontrolled medical condition as determined by treating physician.
- Severe psychological illness.
- History of Inflammatory arthritis.
- Malignancy within past 5 years except basal cell or squamous cell skin cancer. 10. Current opioid use exceeding50morphinemilligram equivalents per day.
- A history of alcohol or drug abuse within past 5 years. 12. Use of any investigational drug within past 30 days. 13. Pending litigation involving participant's residual limb pain. 14. Incarceration
Data sourced from ClinicalTrials.gov (NCT04538417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.