Surgical Treatment of Chronic Neuropathic Pain (Rethink Pain)

March 25, 2024 updated by: Axogen Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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".
1 year
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
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
Time Frame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
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
Time Frame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
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
Time Frame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
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
Time Frame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
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)
Time Frame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: Baseline
Patient demographic information such as age, relevant medical history, mode of injury, and repair (if performed) will be reported.
Baseline
Healthcare Resource History
Time Frame: Baseline
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
Time Frame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
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)
Time Frame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Axogen Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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