Pain, Pain, Back, Spinal Cord Stimulation
Conditions
Brief summary
The purpose of this study is to evaluate the effect of pulse widths \<500 µS and \>1000 µS on clinical outcomes during a temporary SCS trial.
Detailed description
The proposed study is a prospective, single-center, two arm, randomized, crossover design to be conducted at The Ohio Pain Clinic. The study will enroll up to 15 subjects in order to include up to 10 subjects in the study. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algostim system with percutaneous leads. Each subject will be followed during the trial period of approximately 7 days. The study will end when the last subject has completed the trial period. exited. The expected enrollment period for this study is approximately three months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.
Interventions
The Algovita™ SCS 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 failed back surgery syndrome, intractable low back pain and leg pain.
Sponsors
Amol Soin
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement * Study candidate is undergoing a SCS trial using Nuvectra Algostim system * Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form. * Subject is 18 years of age or older when written informed consent is obtained
Exclusion criteria
* Subject is contraindicated for an Algovita SCS system * Subject has a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments * Subject has a life expectancy of less than 2 years * Subject is participating in another clinical study that would confound data analysis * Subject has a coexisting pain condition that might confound pain ratings * Subject has a significant psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Pain Relief | up to 8 days | The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Preference | Up to 8 days | Subjects will be asked to select their favorite program |
| Quality of Pain Relief | Up to 8 days | Subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following scale; Excellent, Very Good, Good, Fair or Poor |
| Distribution of Paresthesia | Up to 8 days | 1\. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia. |
| Achievement of ≥50% Pain Relief | Up to 8 days | Number of patients who achieved ≥ 50% pain relief during the trial (from either arm). The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. |
| Rate of AEs | From spinal cord stimulation implant through study completion or study exit, Up to 8 days | Rate of device-related and/or procedure-related AEs |
| Subject Satisfaction | Up to 8 days | Subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Crossover study design, all participant data is collected together. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Subject Pain Relief
The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours.
Time frame: up to 8 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| <500 µS Pulse Width | Subject Pain Relief | 56 percentage of pain relief |
| >1000 µS Pulse Width | Subject Pain Relief | 61 percentage of pain relief |
Secondary
Achievement of ≥50% Pain Relief
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm). The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale.
Time frame: Up to 8 days
Population: 10 patients in total, crossover design.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| <500 µS Pulse Width | Achievement of ≥50% Pain Relief | 5 Participants |
| >1000 µS Pulse Width | Achievement of ≥50% Pain Relief | 8 Participants |
Secondary
Distribution of Paresthesia
1\. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Time frame: Up to 8 days
Population: This information was not collected.
Secondary
Quality of Pain Relief
Subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following scale; Excellent, Very Good, Good, Fair or Poor
Time frame: Up to 8 days
Population: This information was not collected.
Secondary
Rate of AEs
Rate of device-related and/or procedure-related AEs
Time frame: From spinal cord stimulation implant through study completion or study exit, Up to 8 days
Population: 10 patients total, crossover design
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| <500 µS Pulse Width | Rate of AEs | 0 participants experienced AE |
Secondary
Subject Preference
Subjects will be asked to select their favorite program
Time frame: Up to 8 days
Population: 1 subject preferred both programs equally.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| <500 µS Pulse Width | Subject Preference | 4 Participants |
| >1000 µS Pulse Width | Subject Preference | 7 Participants |
Secondary
Subject Satisfaction
Subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied
Time frame: Up to 8 days
Population: This information was not collected.