Back Pain, Chronic Pain, Failed Back Surgery Syndrome, Pain, Pain, Intractable
Conditions
Keywords
Pain, Chronic Pain, Neurostimulation
Brief summary
There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous Electrical Nerve Stimulation (TENS) and nerve blocks. Historically, the mainstay of pain treatment has been pharmacotherapy. However, pharmacotherapy has varying degrees of effectiveness and is often associated with undesirable side effects. Although many patients are successfully treated, for those who fail some of these more conservative therapies the remaining option is limited to spinal cord stimulation (SCS), proven to be an effective therapy to more than half of those failing conservative treatments . Over 50% of those who have failed these more conservative methods of pain management, can now, under the guidance of a clinician utilizing SCS, have their pain levels successfully managed. SCS is a less invasive therapy that is a reversible treatment with greater long-term benefits than more permanent, radical approaches and one that deserves greater consideration in the management of chronic, intractable pain.
Detailed description
This clinical trial was a confirmatory study for the Advanced Bionics totally implantable Spnial Cord Stimulation(SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: Dailed back surgery syndrome, intractable low backpain and leg pain.
Interventions
DEVICEPrecision SCS
Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain. 2. Be an appropriate candidate for surgery. 3. Be capable of giving informed consent. 4. Be capable and willing to follow all study related procedures.
Exclusion criteria
1. Have an inability to operate the system either by self or care-giver. 2. Are currently participating or have participated within the past 30 days in any clinical investigation that could conflict with the requirements of this study. 3. Have any implanted electrical devices, regardless of whether active or inactive. 4. Have any active implantable device regardless of whether stimulation is ON or OFF.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. | 2 weeks post initial fitting | The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal tono pain and 10 is equal to worst pain imaginable. This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation (SCS) Group Precision Spinal Cord Stimulation therapy group | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Only received temporary implants | 16 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation (SCS) Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Age Continuous | 52 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 65 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 65 |
| serious Total, serious adverse events | 12 / 65 |
Outcome results
Primary
Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.
The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal tono pain and 10 is equal to worst pain imaginable. This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS.
Time frame: 2 weeks post initial fitting
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Cord Stimulation (SCS) Group | Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting. | 35 participants with > 50% VAS improvement |