NCT03159169

Treatment of Neck and Upper Limb Pain Using BurstDR (De Ridder) Stimulation

Treatment of Neck and Upper (NU) Limb Pain Using BurstDR Stimulation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open label, multicenter feasibility study to evaluate the safety and therapeutic efficacy of BurstDRTM SCS in treating chronic neck pain with or without radiation down to arm/shoulder/upper back

Detailed description

Subjects diagnosed with chronic intractable neck pain with or without radiation down to arm/shoulder/upper back will be considered for inclusion in this study. After baseline evaluation, subjects will undergo a SCS trial using the Abbott Invisible Trial system. At the end of the SCS trial, subjects experiencing at least 50% pain relief, according to average neck VAS (calculated by the average of last 3 days on the pain diary), will be considered for permanent implant and further participation in the study. Pain intensity, quality of life, disability, headache severity, sleep quality, patient satisfaction, anxiety, depression, stimulation sensation and medication usage assessments will be performed at baseline, after SCS trial and at the 3, 6 and 12 month follow up visits.

Conditions

• Neck Pain
• Upper Limb Pain

Interventions

Type	Name	Description
DEVICE	Spinal Cord Stimulation (SCS)	Implantation of SCS electrodes and stimulator according to clinical standards

Timeline

• Start date: 2018-05-15
• Primary completion: 2022-04-30
• Completion: 2022-08-31
• First posted: 2017-05-18
• Last updated: 2024-09-23

Locations

3 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated device study