Surgical Treatment of Chronic Neuropathic Pain (Rethink Pain)

An Ambispective, Multicenter, Observational Registry Study of Patients Considering Surgical Treatment for Chronic Neuropathic Pain

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Neuropathic Pain
• Intervention / Treatment: Procedure: Surgical Management of Neuroma

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Foundation for Orthopaedic Research and Education
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Indiana Hand to Shoulder Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • McLean, Virginia, United States, 22102
      • Washington Nerve Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery; Participants who elect to undergo surgery for the treatment of their chronic, neuropathic pain	Procedure: Surgical Management of Neuroma; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance: Change in Visual Analog Scale (VAS) for Pain Score at 1 year in both the surgery and non-surgery cohorts	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".	1 year
Safety: Serious Adverse Events (SAEs)	The primary safety endpoint will compare the nature and incidence of SAEs between the surgery and non-surgery cohorts.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain. The PROMIS - pain related measures being utilized in this study include domains evaluating pain intensity, pain interference, and sleep disturbance. Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measures where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., sleep disturbance). PROMIS instruments are scored using item-level calibrations based on response patterns by Health Measures Scoring Service.	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	The Beck Depression Inventory is a 21-question multiple choice patient self-report inventory and is one of the most widely used psychometric tests for measuring the severity of depression and is comprised of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished as well as physical functions such as fatigue, weight loss and lack of interest in sex. The inventory is scored by adding the patients response to each of the 21 multiple choice questions. Higher scores indicated a greater severity of depression.	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	The Neuro-QoL is a measurement system that evaluates and monitors physical, mental and social effects experienced by patients living with neurological conditions. The Neuro-QoL Anxiety Short form is an 8-item patient reported questionnaire that measures symptoms related to feelings of anxiety including nervousness, worry, feelings of being overwhelmed, panic, and unease. The questionnaire is scored by adding the patients response to each of the questions. Higher scores indicate a greater level of anxiety.	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	The QuickDASH is an abbreviated version of the original DASH outcomes measures and is comprised of an 11-item patient reported questionnaire used to assess physical function and severity of symptoms in patients with musculoskeletal disorders of the upper limb. Each of the items in the QuickDASH use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula ([sum of n responses)/n]-1)(25), where n represents the number of completed items. Computed scores range from 0 (no disability) to 100 (most severe disability).	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	The Lower Extremity Functional Scale is a 20-item self-reported questionnaire related to a person's ability to perform everyday tasks. The LEFS can be used to evaluate the functional impairment of a patient with a disorder in one or both lower extremities. It can be used to monitor progress over time and determine the effectiveness of an intervention. The LEFS is scored on a scale of 0 - 80 and is scored by adding the responses to each of the 20 items. A higher score indicates a higher level of functional activity.	1, 3, 6, 9, and 12 months, 2 years, and 3 years
SAEs and/or Adverse Events (AEs)	The secondary safety endpoint will compare the nature and incidence of SAEs, AEs between the surgery and non-surgery cohorts	1, 3, 6, 9, and 12 months, 2 years, and 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Patient demographic information such as age, relevant medical history, mode of injury, and repair (if performed) will be reported.	Baseline
Healthcare Resource History	History of all healthcare resource use (specialists visits, diagnosis, and all therapies and treatments for pain) and associated referral pathways prior to enrollment in this study will be collected via subject self-report.	Baseline
Health Care Economic Impact based on Resource Utilization and Associated Costs	Procedural costs and healthcare resource utilization including procedural resources and costs, post-procedure medications, rehabilitation resources, and re-hospitalizations will be described. Patients will be evaluated for cost of care in United States Dollars (USD) throughout the course of their recovery or until lost to follow-up using available data in the medical record.	1, 3, 6, 9, and 12 months, 2 years, and 3 years
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP)	The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a 6-item questionnaire relating to the effect a specific health problem has on a person's ability to work and perform regular activities. The WPAI:SHP can be used to monitor the percentage of work time missed due to problem, percent impairment while working due to problem, percent of overall work impairment due to problem, and percent activity impairment due to problem.	1, 3, 6, 9, and 12 months, 2 years, and 3 years

Collaborators and Investigators

• Sponsor: Axogen Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: February 22, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Pain; Neuropathic Pain; Peripheral Nerve Injuries; Peripheral Nervous System Disease; Neuroma; Symptomatic Neuroma
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: PAI-CP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No