Back Pain, Pain
Conditions
Brief summary
The purpose of this study is to evaluate the effect of pulse widths \<500 μsec and \>1000 μsec on clinical outcomes during a temporary SCS trial.
Detailed description
The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include up to 10 subjects in the study per site. 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 Algovita® system with percutaneous leads. Each subject will be followed during the trial period of approximately 7+/-2 days. The study will end when the last subject has completed the trial period and exited. The expected enrollment period for this study is approximately six 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
Ohio Pain Clinic
Kettering Health Network
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
* be eligible for SCS therapy according to the Algovita® SCS system Indications for Use statement * be undergoing a SCS trial using Algovita® SCS system * sign a valid, Institutional Review Board (IRB)-approved informed consent form. * be 18 years of age or older when written informed consent is obtained
Exclusion criteria
* be contraindicated for an Algovita® SCS system * have a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments * have a life expectancy of less than 2 years * be participating in another clinical study that would confound data analysis * have a coexisting pain condition that might confound pain ratings * have a significant psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Pulse Widths on Pain Clinical Outcomes | For 7 days following intervention | To evaluate the effect of conventional pulse widths \<500 μsec and pulse widths \>1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Paesthesia | For 7 days following intervention | At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia. |
| Research Participant Program Preference | For 7 days following intervention | At the end of the trial period, subjects will be asked to select their favorite program. |
| Quality of Pain Relief | For 7 days following intervention | At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor |
| Change in Targeted Pain | For 7 days following intervention | To evaluate the effect of conventional pulse widths \<500μsecand pulse widths and \>1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period. |
| ≥ 50% Pain Relief | For 7 days following intervention | Number of patients who achieved ≥ 50% pain relief during the trial (from either arm) |
| Rate of AEs | For 7 days following intervention | Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit. |
| Research Participant Pain Relief Satisfaction | For 7 days following intervention | At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied |
Countries
United States
Participant flow
Pre-assignment details
patients received both doses
Participants by arm
| Arm | Count |
|---|---|
| Total Patient Population This was a case series and all patients received both algorithms; pulse widths \<500 µsec and \>1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population.
Algovita Spinal Cord Stimulation System: 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Total Patient Population | — |
|---|---|---|
| Age, Continuous | 52 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Effect of Pulse Widths on Pain Clinical Outcomes
To evaluate the effect of conventional pulse widths \<500 μsec and pulse widths \>1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.
Time frame: For 7 days following intervention
Population: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Patient Population | Effect of Pulse Widths on Pain Clinical Outcomes | Patient subjectively felt coverage was larger with wide pulse width program | 15 Participants |
| Total Patient Population | Effect of Pulse Widths on Pain Clinical Outcomes | Patient subjectively felt coverage was larger with conventional pulse width program | 0 Participants |
Secondary
≥ 50% Pain Relief
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)
Time frame: For 7 days following intervention
Population: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Patient Population | ≥ 50% Pain Relief | Achieved >/= 50% pain relief during the trial (from either arm) | 15 Participants |
| Total Patient Population | ≥ 50% Pain Relief | Did not achieve >/= 50% pain relief during the trial (from either arm) | 0 Participants |
Secondary
Change in Targeted Pain
To evaluate the effect of conventional pulse widths \<500μsecand pulse widths and \>1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period.
Time frame: For 7 days following intervention
Population: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Patient Population | Change in Targeted Pain | Patient reported no significant change in pain scores/pain relief | 15 Participants |
| Total Patient Population | Change in Targeted Pain | Patient reported significant change in pain scores/pain relief | 0 Participants |
Secondary
Distribution of Paesthesia
At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Time frame: For 7 days following intervention
Population: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Patient Population | Distribution of Paesthesia | Larger coverage area with wide pulse width | 15 Participants |
| Total Patient Population | Distribution of Paesthesia | Larger coverage area with conventional pulse width | 0 Participants |
Secondary
Quality of Pain Relief
At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor
Time frame: For 7 days following intervention
Population: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Patient Population | Quality of Pain Relief | Excellent | 6 Participants |
| Total Patient Population | Quality of Pain Relief | Very Good | 5 Participants |
| Total Patient Population | Quality of Pain Relief | Good | 4 Participants |
| Total Patient Population | Quality of Pain Relief | Fair | 0 Participants |
| Total Patient Population | Quality of Pain Relief | Poor | 0 Participants |
Secondary
Rate of AEs
Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.
Time frame: For 7 days following intervention
Population: was not collected
Secondary
Research Participant Pain Relief Satisfaction
At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied
Time frame: For 7 days following intervention
Population: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Patient Population | Research Participant Pain Relief Satisfaction | Neither Satisfied nor Unsatisfied | 0 Participants |
| Total Patient Population | Research Participant Pain Relief Satisfaction | Unsatisfied | 0 Participants |
| Total Patient Population | Research Participant Pain Relief Satisfaction | Very Satisfied | 12 Participants |
| Total Patient Population | Research Participant Pain Relief Satisfaction | Satisfied | 3 Participants |
| Total Patient Population | Research Participant Pain Relief Satisfaction | Very Unsatisfied | 0 Participants |
Secondary
Research Participant Program Preference
At the end of the trial period, subjects will be asked to select their favorite program.
Time frame: For 7 days following intervention
Population: Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Patient Population | Research Participant Program Preference | Preferred wide pulse width | 9 Participants |
| Total Patient Population | Research Participant Program Preference | preferred conventional pulse width | 6 Participants |