Pain Clinical Trial
— TMROfficial title:
Targeted Reinnervation as a Means to Treat Neuromas Associated With Major Limb Amputation
Verified date | January 2018 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Subjects are being asked to participate in this study because they have an arm or leg
amputation and have developed pain related to a neuroma (an ongoing localized pain related to
a cut nerve ending).
We are studying two different types of surgery to treat the neuroma pain. Today there are
many surgical options reported which often means that there is no one best treatment. The
surgery that shows the best success so far, involves cutting out the scarred nerve ending
(neuroma) and burying the freshly cut nerve ending in a nearby muscle. Recently, a new
surgery has been developed called targeted reinnervation (TR). This surgery connects these
cut nerve endings to nerves going into nearby nonfunctional muscles. This surgery was
developed to allow amputees to have better prosthesis control. By chance, neuroma pain
improved significantly with TR. We, therefore, are conducting this clinical trial to evaluate
which of these two surgeries best treats neuroma pain. We will ask all participants to fill
out a questionnaire both before and after surgery. This will help us understand how a neuroma
affects the quality of life of amputees and will allow us to understand which surgery leads
to the best improvement in neuroma pain.
In order to confirm the presence and location of the neuroma before surgery, a magnetic
resonance image (MRI) will be performed. Taking these pictures requires subjects to lie still
for a short period of time but does not involve any invasive procedures. After surgery, the
MRI will be done again, this time to see if the nerve shows signs of scarring.
Status | Completed |
Enrollment | 27 |
Est. completion date | January 1, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult, 18 years or older: the Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire is not validated for pain-related evaluation in minors - An upper limb amputation above the wrist with or without a residual limb or a lower limb amputation above the ankle with a residual limb (individuals with a hip disarticulation amputation lack suitable target muscles for TR) - A neuroma within the residual limb: defined as patient-reported chronic localized pain consistent with a physical exam that demonstrates that the pain is related to a cut nerve and excludes other causes. There must be a supporting Tinel's sign on physical exam, MRI findings suggestive of a neuroma, or localization of a neuroma by prior intervention (surgical or otherwise) to distinguish the pain from phantom limb pain or cold intolerance that are nonspecific signs of nerve damage that would not be affected by treatment of a neuroma. - English or Spanish speaking: the PROMIS questionnaire is available in English and parts are currently available in Spanish. The portions that are currently unavailable in Spanish will be translated into Spanish for the purposes of this study. Exclusion Criteria: - Prior TR Surgery: these patients have already had a procedure to improve their prosthetic function and in these cases the nerves have been shortened. To perform a second TR procedure with the previously shortened nerves would require a significant proximal dissection and potentially greater soft tissue morbidity than the standard treatment. - Cognitive impairment, due to TBI or other causes, sufficient to adversely affect understanding of or compliance with study requirements, ability to respond to questionnaires, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant feedback through questionnaires is essential to this study. - Pre-operative assessment that precludes the patient from being eligible for TR or control surgery due to technical surgical concerns. - Significant other comorbidity: Any other medical issues or injuries that would preclude safe administration of anesthesia or surgical intervention. - Participation in other ongoing studies related to neuropathic pain. |
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Northwestern University | Chicago | Illinois |
United States | The Ohio State University | Columbus | Ohio |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | San Antonio Military Medical Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in pain of the amputated limb after surgery | Difference in patient-reported pain scores before and after surgical treatment using the online survey tool. Compare patient-reported pre-operative survey results to those after surgical intervention at intervals over time (1 month, 3 months,6 months, 9 months,1 year, and then every six months thereafter until the conclusion of the study). |
12 months | |
Secondary | Improvement in physical functioning, including prosthesis wear, after surgery | Using the same PROMIS platform, general health, physical functioning (including functional prosthesis wear), and satisfaction following surgery will also be assessed as important secondary outcomes, resulting in a more comprehensive and objective understanding of the effects of the two surgical approaches on neuroma pain. Another particularly useful tool for this study is the Orthotics and Prosthetics User Survey (OPUS) Functional Status. The OPUS is a validated instrument that assesses how well patients are using their prostheses. Thus, we will examine a very important secondary measure of neuroma pain—the ability to use a prosthesis. Prosthesis use is often the primary problem for individuals with painful neuromas; they hurt most during walking with a prosthesis or when wearing a prosthetic arm. Thus we expect OPUS to be a useful additional measure for quantifying the outcomes of the two types of neuroma surgeries |
12 months | |
Secondary | Using MRI as a tool to determine if targeted muscle reinnervation prevents neuroma recurrence | In our study, pre- and post-operative neuroma size (at one year) will be quantified using MRI scans. Pre-operative MRI measurements will be compared to the removed neuroma specimen to verify the accuracy of the modality. Post-operative MRI measurements will be used to assess whether a neuroma recurred at the site of the surgery and to determine the size of any new lesion. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|