Chronic Pain
Conditions
Keywords
back pain, neuromodulation, spinal peripheral neuromodulation, spinal cord stimulation, postlaminectomy pain syndrome
Brief summary
To determine the best parameters with various leads to cover back and leg pain and provide best pain relief
Detailed description
Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.
Interventions
DEVICEpreset program
Change to different present program using epidural and peripheral lead to cover pain
Sponsors
Abbott Medical Devices
Carolinas Center for Advanced Management of Pain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* spinal cord stimulator implant within last 3 weeks * NRS \> 6 * at least 22 years old * patients who agree not to add or increase their pain medications during the study
Exclusion criteria
* patients with prior spinal cord stimulators * pregnancy * infusion pump * history of substance abuse or dependency in last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (Pain) | Weeks 4, 6 and 8 | 0 (no pain)- 10 (worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program. | weeks 4, 6, and 8 | percentage of pain relief- self report |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants were randomized to 1 of 3 programs. Data were collected every 2 weeks at the completion of each program. Participants chose their preferred program from the previous 3 for the next 12 weeks. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 50 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Numeric Rating Scale (Pain)
0 (no pain)- 10 (worst pain imaginable)
Time frame: Weeks 4, 6 and 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 | Numeric Rating Scale (Pain) | 5.2 units on a scale | Standard Deviation 1.6 |
| Program 2 | Numeric Rating Scale (Pain) | 5.2 units on a scale | Standard Deviation 2.2 |
| Program 3 | Numeric Rating Scale (Pain) | 5.3 units on a scale | Standard Deviation 1.6 |
Secondary
Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.
percentage of pain relief- self report
Time frame: weeks 4, 6, and 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Program 1 | Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program. | 52 percentage of pain relief | Standard Deviation 22 |
| Program 2 | Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program. | 46 percentage of pain relief | Standard Deviation 27 |
| Program 3 | Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program. | 46 percentage of pain relief | Standard Deviation 21 |