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Neurostimulation Device

Spinal Cord Stimulation Group for Leg Pain

N/A
Waitlist Available
Led By Ram Haddas, PhD
Research Sponsored by Texas Back Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 6 and 12 weeks after surgery
Awards & highlights

Study Summary

Spinal Cord Stimulation (SCS) uses electrical signals to disrupt noxious signals arising from painful areas, thereby reducing pain perception. Successful SCS implants lead to a broad range of positive outcomes: 1) long-term pain can be expected to be reduced by at least by 50%; 2) quality of life as assessed by subjective measurements improves substantially; 3) patients can significantly reduce opioid medication intake.1 However, the impacts of SCS intervention on neuromuscular and biomechanical outcomes including gait and balance have not been fully explored. Fifty subjects with symptomatic leg pain and/or low back pain (LBP) who are deemed appropriate SCS candidates and are scheduled for surgery will undergo gait and balance analyses preoperatively as well as 6 weeks and 3 months post operatively. In addition, 50 control subjects having no pain will undergo 1 session of gait and balance assessment. Objective spine and lower extremity motion and neuromuscular control will be evaluated using dynamic surface EMG and a video motion capture system during functional evaluation. Also, explored will be the relationship of changes in gait and balance to psychosocial factors that have previously been shown to be correlated with SCS outcomes.

Eligible Conditions
  • Chronic Lower Back Pain
  • Leg Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 6 and 12 weeks after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 6 and 12 weeks after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kinematic Variables Change assessed with human motion capture system
Secondary outcome measures
Patient Self-Reported Outcome Assessments Change - Minnesota Multiphasic Personality Inventory - 2 - Restructured Form (MMPI-2-RF).
Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a).
Patient Self-Reported Outcome Assessments Change - Tampa Scale for Kinesiophobia (TSK).
+1 more
Other outcome measures
Kinetic Variables Change assessed with human motion capture system
Neuromuscular Variables Change assessed with an Electromyography
Spatio-Temporal Variables Change assessed with human motion capture system

Side effects data

From 2019 Phase 4 trial • 30 Patients • NCT03284411
10%
Device stimulation issue
3%
Inadequate analgesia
3%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spinal Cord Stimulation

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Spinal Cord Stimulation GroupExperimental Treatment1 Intervention
Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery
Group II: Control GroupActive Control1 Intervention
Gait and balance testing to be administered once in healthy subjects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Stimulation
2020
Completed Phase 4
~90

Find a Location

Who is running the clinical trial?

Texas Back InstituteLead Sponsor
6 Previous Clinical Trials
465 Total Patients Enrolled
MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,565 Total Patients Enrolled
Ram Haddas, PhDPrincipal InvestigatorTexas Back Institute
2 Previous Clinical Trials
130 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~15 spots leftby Apr 2025