Surgical Treatment of Chronic Neuropathic Pain (Rethink Pain)

Axogen

Status: Terminated

Conditions: Chronic Neuropathic Pain

Treatments: Procedure: Surgical Management of Neuroma

Study type: Observational

Funder types: Industry

Identifiers

NCT04287075

PAI-CP-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

8 participants in 2 patient groups

Surgery

Description:

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

Treatment:

Procedure: Surgical Management of Neuroma

Non-surgery

Description:

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