TerminatedNot Applicable

Surgical Treatment of Chronic Neuropathic Pain

Stopped: The study was terminated due to lower than expected enrollment. The decision to terminate the study was not based on any safety or efficacy concerns.

United States8 participantsStarted 2020-02-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 1 year

Safety: Serious Adverse Events (SAEs)

Timeframe: 1 year

Trial details

NCT IDNCT04287075

SponsorAxogen Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-01-24

View on ClinicalTrials.gov More Chronic Neuropathic Pain trials