Surgical Treatment of Chronic Neuropathic Pain

NCT04287075 | Terminated

• 1 other identifier: PAI-CP-001
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 4

Brief Summary

Observational registry study assessing the subject's pain history and the impact of surgery for the treatment of chronic neuropathic pain by comparing post-operative outcomes (pain level, pain medication usage, quality of life outcomes, and nerve functional outcome) to pre-operative levels.

Conditions

Chronic Neuropathic Pain

Keywords

Peripheral Nerve Injuries; Peripheral Nervous System Disease; Neuropathic Pain; Neuroma; Chronic Pain; Symptomatic Neuroma

Outcome Measures

Primary Outcomes (2)

• Performance: Change in Visual Analog Scale (VAS) for Pain Score at 1 year in both the surgery and non-surgery cohorts

  The Visual Analog Scale (VAS) for Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10-centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable".

  1 year

• Safety: Serious Adverse Events (SAEs)

  The primary safety endpoint will compare the nature and incidence of SAEs between the surgery and non-surgery cohorts.

  1 year

Secondary Outcomes (6)

• Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through 3 years compared to baseline in both the surgery and non-surgery cohorts

  1, 3, 6, 9, and 12 months, 2 years, and 3 years

• Change in Beck Depression Inventory Scale through 3 years compared to baseline in both the surgery and non-surgery cohorts

  1, 3, 6, 9, and 12 months, 2 years, and 3 years

• Change in Neuro-QoL Anxiety Short Form Score through 3 years compared to baseline in both the surgery and non-surgery cohorts

  1, 3, 6, 9, and 12 months, 2 years, and 3 years

• Change in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score through 3 years compared to baseline in both the surgery and non-surgery cohorts

  1, 3, 6, 9, and 12 months, 2 years, and 3 years

• Change in Lower Extremity Functional Score (LEFS) through 3 years compared to baseline in both the surgery and non-surgery cohorts

  1, 3, 6, 9, and 12 months, 2 years, and 3 years

Other Outcomes (4)

• Demographics

  Baseline

• Healthcare Resource History

  Baseline

• Health Care Economic Impact based on Resource Utilization and Associated Costs

  1, 3, 6, 9, and 12 months, 2 years, and 3 years

Study Arms (2)

Surgery

Participants who elect to undergo surgery for the treatment of their chronic, neuropathic pain

Procedure: Surgical Management of Neuroma

Non-surgery

Participants who elect to not have surgery for the treatment of their chronic, neuropathic pain

Interventions

Surgical Management of Neuroma PROCEDURE

Surgical procedures targeted to treat the source of a participant's chronic, neuropathic pain

Surgery

Eligibility Criteria

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

Study Population

Adult male and female subjects (age ≥ 18 years old) presenting for evaluation for surgery for the treatment of chronic, neuropathic pain

You may qualify if:

• Be Age ≥ 18 years
• Have a documented diagnosis of chronic neuropathic pain
• In the opinion of the investigator, be considered at the time of screening a likely candidate for surgical treatment of their neuropathic pain according to institutional standard of care.
• Be willing to participate in data collection and all follow-up assessments throughout and for the entire duration of follow-up

You may not qualify if:

• Subjects who, in the opinion of the investigator, have not or likely will not complete the required follow-up assessments.
• Subjects who are currently enrolled in another clinical trial;
• Subjects who have undergone previous surgical treatment of pain from symptomatic neuroma in the target nerve(s);
• Subjects who are undergoing treatment(s)/intervention(s) for other condition(s) which, in the opinion of the investigator, may confound assessment of pain or interfere with the study measurements.

Sponsors & Collaborators

• Axogen Corporation: lead

Study Sites (4)

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637, United States

Location

Indiana Hand to Shoulder Center

Indianapolis, Indiana, 46260, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Washington Nerve Institute

McLean, Virginia, 22102, United States

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries; Peripheral Nervous System Diseases; Neuralgia; Neuroma; Chronic Pain

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 27, 2020
• Study Start: February 19, 2020
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)