Clinical trial NCT04287075: Surgical Treatment of Chronic Neuropathic Pain
Official title: An Ambispective, Multicenter, Observational Registry Study of Patients Considering Surgical Treatment for Chronic Neuropathic Pain
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Neuropathic Pain
Keywords: Peripheral Nerve Injuries
Peripheral Nervous System Disease
Neuropathic Pain
Neuroma
Chronic Pain
Symptomatic Neuroma
Lead sponsor: Axogen Corporation
Sponsor class: INDUSTRY
First posted: 2020-02-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Performance: Change in Visual Analog Scale (VAS) for Pain Score at 1 year in both the surgery and non-surgery cohorts
timeFrame: 1 year
measure: Safety: Serious Adverse Events (SAEs)
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
measure: Change in Beck Depression Inventory Scale through 3 years compared to baseline in both the surgery and non-surgery cohorts
timeFrame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
measure: Change in Neuro-QoL Anxiety Short Form Score through 3 years compared to baseline in both the surgery and non-surgery cohorts
timeFrame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
measure: 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
timeFrame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
measure: Change in Lower Extremity Functional Score (LEFS) through 3 years compared to baseline in both the surgery and non-surgery cohorts
timeFrame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
measure: SAEs and/or Adverse Events (AEs)
timeFrame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
Other outcomes:
measure: Demographics
timeFrame: Baseline
measure: Healthcare Resource History
timeFrame: Baseline
measure: Health Care Economic Impact based on Resource Utilization and Associated Costs
timeFrame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
measure: Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP)
timeFrame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
Locations:
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder Center
state: Indiana
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: McLean
country: United States
facility: Washington Nerve Institute
state: Virginia
Study officials:
References: