NCT03740763

Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain

Treatment of Neuropathic Pain With Spinal Cord Stimulation and Physiotherapy for More Effective Pain Relief, Increased Physical Activity and Improved Health Related Quality of Life

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Göteborg University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the combined effect of optimized pharmacological treatment, spinal cord stimulation and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. All patients will receive optimized pharmacological treatment before start of spinal cord stimulation treatment. Half of the participants will be randomized to physiotherapy before start of spinal cord stimulation treatment while the other half will start physiotherapy after spinal cord stimulation treatment.

Detailed description

Previous studies have indicated that almost half of the patients with moderate-severe pain receive inadequate pain relief. Neuropathic pain is a common pain condition, affecting 1.5-8% of the population. Conventional pharmacological treatment reduces pain but is often insufficient. Spinal cord stimulation (SCS) is associated with improved pain relief and health-related quality of life compared to conventional medical management. Despite SCS treatment, only half of the patients report \>50% pain relief. Other studies have indicated that active, specific physiotherapy led by professionals reduces pain in chronic pain conditions. The aim of the study is to access the combined effect of optimized pharmacological treatment, SCS and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. Furthermore, the study evaluates when it is most effective to start the physiotherapy.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	Spinal Cord Stimulation (SCS)	SCS for treatment of neuropathic pain
OTHER	Physiotherapy	Physiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain

Timeline

• Start date: 2018-05-09
• Primary completion: 2022-05-25
• Completion: 2023-11-22
• First posted: 2018-11-14
• Last updated: 2025-05-23

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated device study