Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

Pain Clinical Trial

Official title:

Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756012
• Other study ID #: Expanded Long Pulse
• Status: Completed
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: October 2, 2019

Study information

• Verified date: February 2021
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	The Ohio Pain Clinic	Centerville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kettering Health Network	Ohio Pain Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	For 7 days following intervention
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.	For 7 days following intervention
Secondary	Distribution of Paesthesia	At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.	For 7 days following intervention
Secondary	Research Participant Program Preference	At the end of the trial period, subjects will be asked to select their favorite program.	For 7 days following intervention
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	For 7 days following intervention
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	For 7 days following intervention
Secondary	= 50% Pain Relief	Number of patients who achieved = 50% pain relief during the trial (from either arm)	For 7 days following intervention
Secondary	Rate of AEs	Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.	For 7 days following intervention