Chronic Back and Leg Pain, Chronic Back Pain
Conditions
Brief summary
Prospective, double blinded, randomized, clinical study investigating the effects of high frequency PNS for the treatment of chronic back or back and leg pain.
Detailed description
All subjects will have two permanent stimulators placed over the proximal peripheral nerves at T9 at the implant visit. The stimulators can easily be removed for non-responders. High frequency stimulation is typically programmed below sensory threshold. This type of stimulation lends itself to a placebo-controlled trial. For this study subjects will be randomized 1:1 at enrollment into a high frequency or sham group. Neither the subjects nor experimenters will be made aware of their randomization assignment for at least the first month of the trial. Subjects belonging to both groups will be unblinded to their assignment at the 1-month or a later visit (including unscheduled visit) if they have a VAS \> 30 mms. Subjects belonging to the sham group will be reprogrammed with HF stimulation at this point. Subjects belonging to the HF stimulation group will keep stimulating with HF. Subjects reporting a VAS \< 30 mms will continue to be blinded.
Interventions
DEVICEPNS HF
A needle and catheter is carefully inserted near your spinal column. The stimulator is then placed through the catheter and directed towards the T9 proximal peripheral nerves. The proximal end of the stimulator is then sutured underneath the skin of your back to the fascia to prevent migration.
DEVICEPNS Sham
A needle and catheter is carefully inserted near your spinal column. The stimulator is then placed through the catheter and directed towards the T9 proximal peripheral nerves. The proximal end of the stimulator is then sutured underneath the skin of your back to the fascia to prevent migration.
Sponsors
AZ Delta
GZA Ziekenhuizen Campus Sint-Augustinus
Curonix LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Subjects and assessors randomized to HF blinded Subjects and assessors randomized to sham blinded
Intervention model description
Prospective, partially double-blinded, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is ≥ 18 years of age at time of informed consent; * Subjects have been diagnosed with predominant, chronic, intractable back pain with a VAS \> 50 mm (on a 100-mm scale); * Subjects have been diagnosed with predominant, chronic, intractable back pain for at least 6 months before study participation; * Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment; * Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject; * Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements; * Subject is willing and able to operate the patient programmer, recharging equipment and has the ability to undergo study assessments and provide accurate responses; * Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure; * Subject is male or non-pregnant female; * Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a clinical psychologist and principal investigator, using face-to-face encounters and the psychological testing described in the measures; * Patient is capable of giving informed consent.
Exclusion criteria
* Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months); * Unresolved malignancies in the last six months; * Subject has post-herpetic neuralgia (shingles); * Subject has an active systemic infection or is immune-compromised; * Based on the medical opinion of the Principal Investigator the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study; * Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study; * Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication; * Bleeding complications or coagulopathy issues; * Pregnant/lactating or not using adequate birth control; * A life expectancy of less than one year; * Any active implanted device whether turned off or on; * A previous PNS experience for the treatment of back pain; * Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate | 1 month post-implant | a \> 50% reduction in back pain as measured by VAS with the Freedom PNS system in the HF (test) group as opposed to sham and conventional medical management |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS back pain | 1, 3, 6, 9, 12 and 36 months | Percentage change from baseline in VAS for back pain |
| VAS leg pain | 1, 3, 6, 9, 12 and 36 months | Percentage change from baseline in VAS for leg pain |
| ODI | 1, 3, 6, 9, 12 and 36 months | Change from baseline in functionality using the ODI score |
Other
| Measure | Time frame | Description |
|---|---|---|
| PGIC | 1, 3, 6, 9, 12 and 36 months | Subject satisfaction with the therapy as measured by the Patient Global Impression of Change (PGIC) |
| Non-opioid Pain Medication | 1, 3, 6, 9, 12 and 36 months | Prescribed non-opioid pain medication |
| EQ-5D-5L | 1, 3, 6, 9, 12 and 36 months | Changes from baseline in quality of life |
| AE's | 1, 3, 6, 9, 12 and 36 months | Incidence of device related adverse events |
| Opioid Pain Medication | 1, 3, 6, 9, 12 and 36 months | Prescribed opioid pain medications |
Countries
Belgium
Outcome results
None listed