Back Pain, Chronic Pain, Intractable Pain
Conditions
Brief summary
Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).
Detailed description
This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used. This study will compare the historical pain medication dose and pain scores using the peristaltic pump at baseline as well as from the last pump refill visit prior to explant to the prospective pain medication dose and pain scores using the valve-gated pump and collected at refill visits 1, 2 and 3 after valve-gated pump implant (but not exceed 12 months).
Interventions
DEVICEPrometra II Programmable Pump system(Flowonix Medical)
This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump
Sponsors
Flowonix Medical
Rush University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used.
Intervention model description
Prior Peristaltic Synchromed II intrathecal pump's data prior to crossover to valve-gated Flowonix Prometra® II Programmable Pump is recorded to compare.
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Be male or female between the ages of 22 and 85 years 2. Be capable of giving informed consent and completing assessments required by the study 3. Have pain intensity of greater than 5 out of 10 as measured by VAS 4. Have an active existing peristaltic intrathecal drug delivery system 5. Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant 6. Be an appropriate candidate for surgery 7. Be able to comply with required study visits and assessments including English proficiency
Exclusion criteria
1. Have a significant pain disorder not intended to be treated with the test device or comparator 2. Be terminally ill and/or have a life expectancy of less than 6 months 3. Be a pregnant/lactating woman or a woman of child-bearing potential 4. Have a systemic or local infection (contraindicated for pump implantation) 5. Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments 6. Have an underlying condition increasing susceptibility to infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced pain medication through Prometra Implantable Pump System | 12 months from Implant | Total consumption of Pain medication both oral and intra thecal would also be recorded to show change in pain medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score: Visual Analog Scale for Pain | 12 months from Implant | Visual Analog Scale for Pain is being used assess the pain throughout the 12 month which shows No pain at one end to Pain as bad as it could be at other end. |
Countries
United States
Outcome results
None listed