CompletedNot Applicable

C-RFA of Residual Limb Neuroma

United States8 participantsStarted 2019-10-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Numeric Rating Scale (NRS) for Pain at 6 Months

Timeframe: 6 months

Trial details

NCT IDNCT04538417

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-30

Results submitted2024-02-07

View on ClinicalTrials.gov More Phantom Limb Pain trials