Pain Clinical Trial
Official title:
Targeted Reinnervation for Neuromas as a Means to Improve Prosthesis Control in 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).
The investigators are studying how targeted reinnervation (TR) helps to both treat neuroma
pain and to have increased prosthetic control. 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. The investigators, therefore, are conducting this clinical trial. The investigators
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 amputee will allow us to
understand how to best improve neuroma pain and prosthesis control.
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | January 1, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
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 - 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, 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 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 | University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in pain of the amputated limb after surgery (survey results) | 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 | |
Primary | Improvement in physical functioning (prosthesis wear and function), 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. |
12 months |
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
|