Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

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.

• Algovita Spinal Cord Stimulation System (Device): 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.

Primary outcomes

• 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 outcomes

• 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.
• 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
• 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
• ≥ 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.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Effect of Pulse Widths on Pain Clinical Outcomes (Primary), Count of participants, Participants: Total Patient Population 15
• Change in Targeted Pain (Secondary), Count of participants, Participants: Total Patient Population 15
• Distribution of Paesthesia (Secondary), Count of participants, Participants: Total Patient Population 15
• Research Participant Program Preference (Secondary), Count of participants, Participants: Total Patient Population 9
• Quality of Pain Relief (Secondary), Count of participants, Participants: Total Patient Population 6
• Research Participant Pain Relief Satisfaction (Secondary), Count of participants, Participants: Total Patient Population 12
• ≥ 50% Pain Relief (Secondary), Count of participants, Participants: Total Patient Population 15
• Rate of AEs (Secondary)

Adverse events

Time frame: up to 10 days post-implant

• Study Protocol and Statistical Analysis Plan (PDF, 2014-03-09)