Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04054401
Other study ID # G190045
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 6, 2022
Est. completion date October 2024

Study information

Verified date November 2023
Source SynerFuse, Inc
Contact Gabi Molnar
Phone 612-217-2914
Email Gabi@SynerFuse.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and tolerability of DRG stimulation when placing a neurostimulator during the same procedure as implantation of spinal fixation with or without interbody cage systems in patients with chronic back and/or leg pain requiring single level spinal fusion.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria: - Indicated for a single level or two level adjacent spinal fusion having back pain and radiculopathy - Have been diagnosed with chronic, intractable pain of the lower back and/or leg refractory to conservative therapy for at least 3 of months - At least 6 months since last surgical procedure on the spine - Be 21 years of age or older at the time of enrollment - Be willing and capable of giving informed consent - Be willing and able to comply with study-related requirements Exclusion Criteria: - Any prior spinal fusion at index or adjacent level - Pregnant - Have a life expectancy of less than 1 year - Be concomitantly participating in another clinical study - Be involved in an injury claim under current litigation - Baseline narcotic use of = 100 MME per day - Significant untreated addiction to dependency producing medications - Current active implantable medical device - Cancer - Have osteoporosis - Active infection - Allergies to system components - AGE > 80 - Expected need to undergo MRI imaging in the future - Other significant comorbidities

Study Design


Intervention

Device:
DRG Neurostimulation with Spinal Fusion
Surgeons will implant a neurostimulator during the same open back procedure as fusion devices (spinal fusion hardware and interbody cage) and begin neurostimulation in a short time following surgery (24 hours).

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota
United States South Bend Orthopaedics Mishawaka Indiana

Sponsors (1)

Lead Sponsor Collaborator
SynerFuse, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Amount of device migration Amount of device migration as measured by anteroposterior (AP) and lateral x-rays. Surgery to 3, 6, and 12 months post-op
Other Costs and cost-effectiveness of the intervention The cost effectiveness analysis will report total healthcare-related expenditures reported by patients from baseline to 12 months post-op and 12 month quality-adjusted life-years (QALYs). Incremental cost per QALY will be estimated and compared to previously published studies. Baseline through 12 months post-op
Primary Primary Safety Endpoint: Characterization of device-related adverse events Surgery through 12 months post-op
Primary Primary Effectiveness Endpoint: Change in back and leg pain Visual Analog Score (VAS) scores VAS scores range from 0 (no pain) to 100 (pain is as bad as it could possibly be). Decreases in scores indicate reductions in pain. Baseline to 3 months post-op
Secondary Change in neurological status Change in neurological status measured by the neurological component of the standard physical exam. Baseline to 3, 6, and 12 months post-op
Secondary Change in disability measured by the Oswestry Disability Index (ODI). Each question is scored from 0-5. The scores from each question are summed, then divided by the maximum number possible, then multiplied by 100 to represent a percentage. The percentages are broken down into 5 category ranges: 0% to 20%: minimal disability, 21%-40%: moderate disability; 41%-60%: severe disability; 61%-80%: crippled; 80%-100%: bed-bound or exagerating. Baseline to 3, 6, and 12 months post-op
Secondary Change in quality of life as measured by PROMIS Scale v1.2 - Global Health. The is a 10-item patient-reported questionnaire in which the response options are presented as a 5-point rating scale. The results of the scores are are used to calculate two summary scores: a Global Physical Health score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score." The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. Baseline to 3, 6, and 12 months post-op
Secondary Change in quality of life as measured by EQ-5D-5L. The EQ-5D-5L survey consists of 5 dimensions with the score for each ranging from 1 (no problems) to 5 (unable to do). For individual dimensions, negative changes (e.g. from 5 to 3) indicate improvement. The scores on these five dimensions will be presented as a health profile and converted to a single summary index number (utility). Positive changes in the total score indicate improvement. Baseline to 3, 6, and 12 months post-op
Secondary Change in use of analgesics over time Change in use of medications at all follow up visits. Baseline through 12 months post-op
See also
  Status Clinical Trial Phase
Completed NCT01659073 - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation N/A
Recruiting NCT05914311 - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration N/A
Recruiting NCT05422456 - The Turkish Version of Functional Disability Inventory
Enrolling by invitation NCT05422443 - The Turkish Version of Pain Coping Questionnaire
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04385030 - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury N/A
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05103319 - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed NCT03687762 - Back on Track to Healthy Living Study N/A
Completed NCT04171336 - Animal-assisted Therapy for Children and Adolescents With Chronic Pain N/A
Completed NCT03179475 - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury Phase 4
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Recruiting NCT06060028 - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Terminated NCT03538444 - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT05812703 - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain