Spinal Stimulation to Treat Low Back Pain

Low Back Pain Clinical Trial

Official title:

Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02128672
• Other study ID #: 13-003985
• Status: Withdrawn
• Phase: N/A
• First received: February 18, 2014
• Last updated: March 14, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority of SCS over conventional medical therapy to treat patients with FBSS. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. However, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. Strategies that have been introduced but so far with limited success include transverse multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to reliably overcome the long-term problems of paresthesia capture and pain relief of the low back.

This proposal describes a new spinal stimulation technique designed to improve the likelihood of low back stimulation by targeting the nerve supply to the two most commonly affected pain producing structures in the back, the facet joints and the intervertebral disks. The technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

• Patients with one sided low back pain

• Failed standard conservative care including medications, physical therapy, and/or injections

• Pain greater than 6 months

Exclusion:

• Pregnancy

• Previous spine surgery

• Pain radiating beyond/below the knee

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lumbago
• Lumbar Back Pain

Intervention

Procedure:
• Spinal Cord Stimulator Lead Placement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Did the participant have paresthesia coverage from the stimulation?	This is a simple yes or no outcome. Either the patient is able to feel the stimulation paresthesia in the area of his or her back where he or she has pain (outcome is yes) or they do not feel it (outcome is no).	Baseline to 4 days	No
Secondary	Numeric Pain Rating Scale (NRS)	NRS is a validated back pain outcome scale	Baseline to 4 days	No
Secondary	Patient preferred stimulation-Likert Scale		baseline to 4 days	No