Clinical trial NCT03756012: Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation
Official title: Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Pain
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
Collaborators: name: Ohio Pain Clinic
First posted: 2018-11-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Pulse Widths on Pain Clinical Outcomes
timeFrame: For 7 days following intervention
Secondary outcomes:
measure: Change in Targeted Pain
timeFrame: For 7 days following intervention
measure: Distribution of Paesthesia
timeFrame: For 7 days following intervention
measure: Research Participant Program Preference
timeFrame: For 7 days following intervention
measure: Quality of Pain Relief
timeFrame: For 7 days following intervention
measure: Research Participant Pain Relief Satisfaction
timeFrame: For 7 days following intervention
measure: ≥ 50% Pain Relief
timeFrame: For 7 days following intervention
measure: Rate of AEs
timeFrame: For 7 days following intervention
Other outcomes:
Locations:
city: Centerville
country: United States
facility: The Ohio Pain Clinic
state: Ohio
Study officials:
References: