Surgical Treatment of Chronic Neuropathic Pain

NCT ID: NCT04287075

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-19

Study Completion Date

2024-01-24

Brief Summary

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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.

Detailed Description

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This observational registry will evaluate the subject's healthcare journey and pain history through detailed medical history and record review. For patients who undergo surgical treatment for pain, the registry will capture standardized outcomes measures to assess key factors such as post-operative pain, pain medication usage, quality of life outcomes, and functional outcome of associated nerves as compared to pre-operative levels.

Conditions

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Chronic Neuropathic Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery

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

Surgical Management of Neuroma

Intervention Type PROCEDURE

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

Non-surgery

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

No interventions assigned to this group

Interventions

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Surgical Management of Neuroma

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Be Age ≥ 18 years
2. Have a documented diagnosis of chronic neuropathic pain
3. 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.
4. Be willing to participate in data collection and all follow-up assessments throughout and for the entire duration of follow-up

Exclusion Criteria

1. Subjects who, in the opinion of the investigator, have not or likely will not complete the required follow-up assessments.
2. Subjects who are currently enrolled in another clinical trial;
3. Subjects who have undergone previous surgical treatment of pain from symptomatic neuroma in the target nerve(s);
4. 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axogen Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Foundation for Orthopaedic Research and Education

Tampa, Florida, United States

Site Status

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Washington Nerve Institute

McLean, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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PAI-CP-001

Identifier Type: -

Identifier Source: org_study_id

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