Chronic Neuropathic PainRethink PainNCT04287075

Surgical Treatment of Chronic Neuropathic Pain

An observational study of Chronic Neuropathic Pain, run by Axogen Corporation at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Neuropathic Pain
What is being tested?: Surgical Management of Neuroma
Type of treatment: Surgery or procedure
How many people: 8 participants
Where: 4 sitesUnited States
Study dates: 19 Feb 2020to 24 Jan 2024
How long will I take part?: 3 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult male and female subjects (age ≥ 18 years old) presenting for evaluation for surgery for the treatment of chronic, neuropathic pain

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Chronic Neuropathic Pain
Being tested: Surgical Management of Neuroma
Keywords: Peripheral Nerve Injuries, Peripheral Nervous System Disease, Neuropathic Pain, Neuroma, Chronic Pain, Symptomatic Neuroma
Medical subject headings: Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Neuralgia, Neuroma, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Surgical Management of NeuromaProcedure or surgery
Surgical procedures targeted to treat the source of a participant's chronic, neuropathic pain

Study groups in NCT04287075
Study group	Role	What they receive
Surgery		Participants who elect to undergo surgery for the treatment of their chronic, neuropathic pain Receives: Procedure: Surgical Management of Neuroma
Non-surgery		Participants who elect to not have surgery for the treatment of their chronic, neuropathic pain

What is being measured

The primary outcome is the main question the study is designed to answer.

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".
Measured: 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.
Measured: 1 year

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 1, 3, 6, 9, and 12 months, 2 years, and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Feb 202024 Jan 2024

First posted27 Feb 2020
Study start19 Feb 2020
Primary completion24 Jan 2024
Study completion24 Jan 2024

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Neuropathic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 8 participants (actual)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT04287075
Sponsor's protocol ID: PAI-CP-001
Acronym: Rethink Pain
Status last verified: Mar 2024
First submitted: 22 Feb 2020
Last updated: 26 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Ambispective, Multicenter, Observational Registry Study of Patients Considering Surgical Treatment for Chronic Neuropathic Pain
ClinicalTrials.gov ID: NCT04287075
Acronym / sponsor ID: Rethink Pain / PAI-CP-001
Conditions: Chronic Neuropathic Pain
Keywords: Peripheral Nerve Injuries, Peripheral Nervous System Disease, Neuropathic Pain, Neuroma, Chronic Pain, Symptomatic Neuroma
Study type: Observational
Recruitment status: TerminatedReason 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.
Enrolment: 8 participants (actual)
Lead sponsor: Axogen CorporationIndustry (pharma, biotech, devices)
Study start: 19 Feb 2020 (actual)
Primary completion: 24 Jan 2024 (actual)
Study completion: 24 Jan 2024 (actual)
First posted: 27 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 2

Arm	Type	Receives
Surgery	–	Procedure: Surgical Management of NeuromaParticipants who elect to undergo surgery for the treatment of their chronic, neuropathic pain
Non-surgery	–	–Participants who elect to not have surgery for the treatment of their chronic, neuropathic pain

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult male and female subjects (age ≥ 18 years old) presenting for evaluation for surgery for the treatment of chronic, neuropathic pain

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Surgical Management of NeuromaSurgical procedures targeted to treat the source of a participant's chronic, neuropathic pain	Procedure or surgery	Surgery

Primary outcome

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".
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.

6 secondary outcomes

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
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
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
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
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
SAEs and/or Adverse Events (AEs)
Time frame: 1, 3, 6, 9, and 12 months, 2 years, and 3 years

Results and safety

The study was stopped early (reason given: 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.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
Individual participant dataSharing planned: No

Related trials for Chronic Neuropathic Pain

RecruitingObservational study
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Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
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RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
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A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
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Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Neuropathic Pain, run by Axogen Corporation at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04287075.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.