C-RFA of Residual Limb Neuroma

NCT04538417 | Completed Results DMC FDA Device

• 1 other identifier: IRB 106250
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phantom Limb Pain; Neuroma Amputation

Keywords

Cooled Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) for Pain at 6 Months

  Presented here is the proportion of participants reporting ≥50% improvement in Numeric Rating Scale pain score at 6 months after their cooled radiofrequency ablation procedure. The Numeric Rating Scale was used to quantify neuroma-associated residual limb pain by asking patients to rate their pain intensity on an 11-point scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable".

  6 months

Secondary Outcomes (3)

• Median Change in Numeric Rating Scale (NRS) Scores for Pain

  1, 3, 6, and 12 months

• Medication Quantification Scale III Mean Score

  1, 3, 6 and 12 Months

• Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC)

  1, 3, 6, and 12 months

Study Arms (1)

Residual Limb Pain in affected amputated limb

OTHER

Patient has residual limb pain in amputated limb and is scheduled to receive standard of care treatment of cooled radiofrequency ablation.

Device: Cooled Radiofrequency Ablation

Interventions

Cooled Radiofrequency Ablation DEVICE

RFA procedures will be performed with modification accounting for appropriate C-RFA technique. Participant will be positioned prone and skin prepped with chloroprep. Ultrasound probe will be placed on residual limb at a transverse angle in order to view the nerve and associated neuroma in long-axis. The probe will be advanced to the site of the stump neuroma. C-RFA electrode will be placed adjacent to neuroma. Needle will be connected via wire to a cooled radiofrequency generator. Motor and sensory testing will be performed to reproduce or exacerbate the RLP and / or PLP. At the site of the neuroma, 2 mL of local anesthetic will be injected through the needle. C-RFA lesions will be created by using the typical C-RFA protocol. Upon completion needle will be removed. Following ablation, 0.5 mL of 0.5% bupivacaine will be injected at the site of the ablated neuroma to provide post procedure analgesia.

Residual Limb Pain in affected amputated limb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Results Point of Contact

• Title: Zachary McCormick, MD
• Organization: University of Utah Orthopaedic Center/ Physical Medicine & Rehabilitation

u6014808@umail.utah.edu

801-587-1493

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zachary McCormick, MD FAAPMR, Associate Professor, Director of Clinical Spine Research, Director of Interventional Spine and Musculoskeletal Medicine Fellowship

Model Details: Participants who meet inclusion and exclusion criteria will be enrolled into the study after consenting to participate and before receiving residual limb neuroma C-RFA. This procedure is considered standard of care and are typically based on physician preference. Data will be collected by questionnaire at baseline and select follow up timelines.

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 4, 2020
• Study Start: October 27, 2019
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: January 8, 2025
• Results First Posted: March 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)