NCT02549183

Evaluation of Spinal Cord Stimulation Pulse Rate On Clinical Outcomes

Evaluation of Stimulation Pulse Rate on Clinical Outcomes in Patients Whose Pain is Controlled by 10KHz Frequency - a Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Mid and South Essex NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clinical study to estimate the optimal frequency for stimulation of the spinal cord to achieve relief from back pain.

Detailed description

This is a feasibility study to identify the optimal frequency for stimulation of the spinal cord to achieve maximum reduction in neuropathic back pain as measured by average Numerical rating Scale. Twenty patients who suffer from back more than leg pain will be recruited into the study once they have satisfactory pain relief from both low and high frequency stimulations. Each patient will then receive stimulation at four different frequencies for 2-3 weeks in a random and blinded order. Their pain scores and function will be assessed using a variety of different tools. The data will then be used to estimate the optimal frequency.

Conditions

• Back Pain
• Neuralgia

Interventions

Type	Name	Description
DEVICE	Boston Scientific PRECISION Spinal Cord Stimulator System	Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-07-13
• Completion: 2017-07-13
• First posted: 2015-09-15
• Last updated: 2020-12-22

Locations

3 sites across 1 country: United Kingdom