NCT01776749: SubQ

Subcutaneous Stimulation as Add on Therapy to SCS toTreat Low Back Pain in FBSS

Completed NA Last updated 7 January 2020

What this trial tests

NA trial testing SubQ in Low Back Pain in 100 participants. Completed in 11 July 2015.

Timeline

9 November 2011

Primary endpoint
20 December 2014

11 July 2015

Quick facts

Lead sponsor	SubQ
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	9 November 2011
Primary completion	20 December 2014
Estimated completion	11 July 2015
Sites	1 location across Netherlands

Drugs / interventions tested

• SubQ

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →
• Failed Back Surgery Syndrome — all drugs for Failed Back Surgery Syndrome →
• Neuropathic Pain — all drugs for Neuropathic Pain →

Sponsor

SubQ

Who can join

Adults 18 to 75, any sex, with Low Back Pain or Failed Back Surgery Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aim of the study Failed back surgery syndrome (FBSS) is a clinical entity consisting of chronic leg and /or back pain due to radicular nerve damage. The effectiveness of Spinal Cord Stimulation (SCS) in the pain management of patients with FBSS is proven. Patients mostly have dominant leg pain, however a significant percentage of FBSS patients has a more pronounced back pain and are commonly excluded from SCS as it is often inadequate in relieving both the back and leg pain components. Recently some reports showed the benefit of subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been confirmed by a feasibility study performed by our group. The aim of the randomized controlled study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives an inadequate back pain relief.

Hypothesis We hypothesize that SubQ in addition to SCS in FBSS patients with leg and low back pain is more effective in treating low back pain (i.e. \>50% pain reduction) than SCS alone.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Spinal Cord Stimulation With Additional Peripheral Nerve/Field Stimulation Versus Spinal Cord Stimulation Alone on Back Pain and Quality of Life in Patients With Persistent Spinal Pain Syndrome.
   van Heteren EPZ, van Roosendaal BWP, van Gorp EJAA, Bronkhorst EM, et al · · 2023 · cited 5× · PMID 35088732 · DOI 10.1016/j.neurom.2021.11.010