An Ambispective, Multicenter, Observational Registry Study of Patients Considering Surgical Treatment for Chronic Neuropathic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Neuropathic Pain
- Sponsor
- Axogen Corporation
- Enrollment
- 8
- Locations
- 4
- Primary Endpoint
- Safety: Serious Adverse Events (SAEs)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Detailed 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Safety: Serious Adverse Events (SAEs)
Time Frame: 1 year
The primary safety endpoint will compare the nature and incidence of SAEs between the surgery and non-surgery cohorts.
Performance: Change in Visual Analog Scale (VAS) for Pain Score at 1 year in both the surgery and non-surgery cohorts
Time Frame: 1 year
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".
Secondary Outcomes
- SAEs and/or Adverse Events (AEs)(1, 3, 6, 9, and 12 months, 2 years, and 3 years)
- 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 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 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 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)