Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

Pain Clinical Trial

Official title:

Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526055
• Other study ID #: Long Pulse
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: May 31, 2018

Study information

• Verified date: January 2019
• 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 µS and >1000 µS on clinical outcomes during a temporary SCS trial.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Pain
• Pain, Back
• Spinal Cord Stimulation

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	Ohio Pain Clinic	Centerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Amol Soin

Country where clinical trial is conducted

United States, 

References & Publications (12)

American Chronic Pain Association Resource Guide to Chronic Pain Medication and Treatment, 2014 Edition.

Davis R, Gray E. Technical factors important to dorsal column stimulation. Appl Neurophysiol. 1981;44(1-3):160-70. — View Citation

Gould B, Bradley K. Pulse width programming in spinal cord stimulators. Abstract of the American Academy of Pain Medicine 22nd Annual Meeting, 2006 February 22-25. San Diego, CA

Grill WM Jr, Mortimer JT. The effect of stimulus pulse duration on selectivity of neural stimulation. IEEE Trans Biomed Eng. 1996 Feb;43(2):161-6. — View Citation

Holsheimer J. Effectiveness of spinal cord stimulation in the management of chronic pain: analysis of technical drawbacks and solutions. Neurosurgery. 1997 May;40(5):990-6; discussions 996-9. — View Citation

Jobling DT, Tallis RC, Sedgwick EM, Illis LS. Electronic aspects of spinal-cord stimulation in multiple sclerosis. Med Biol Eng Comput. 1980 Jan;18(1):48-56. — View Citation

Law JD, Lehman RA, Kirsch WM. Reoperation after lumbar intervertebral disc surgery. J Neurosurg. 1978 Feb;48(2):259-63. — View Citation

Lee D, Hershey B, Bradley K, Yearwood T. Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. Med Biol Eng Comput. 2011 Jul;49(7):765-74. doi: 10.1007/s11517-011-0780-9. Epub 2011 Apr 29. — View Citation

Lehmann TR, LaRocca HS. Repeat lumbar surgery. A review of patients with failure from previous lumbar surgery treated by spinal canal exploration and lumbar spinal fusion. Spine (Phila Pa 1976). 1981 Nov-Dec;6(6):615-9. — View Citation

North RB, Campbell JN, James CS, Conover-Walker MK, Wang H, Piantadosi S, Rybock JD, Long DM. Failed back surgery syndrome: 5-year follow-up in 102 patients undergoing repeated operation. Neurosurgery. 1991 May;28(5):685-90; discussion 690-1. — View Citation

Wilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd edition., Philadelphia: Harper & Row, 1991.

Yearwood TL, Hershey B, Bradley K, Lee D. Pulse width programming in spinal cord stimulation: a clinical study. Pain Physician. 2010 Jul-Aug;13(4):321-35. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 8 days
Secondary	Distribution of Paresthesia	1. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.	Up to 8 days
Secondary	Subject Preference	Subjects will be asked to select their favorite program	Up to 8 days
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	Up to 8 days
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	Up to 8 days
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.	Up to 8 days
Secondary	Rate of AEs	Rate of device-related and/or procedure-related AEs	From spinal cord stimulation implant through study completion or study exit, Up to 8 days