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Effect of Spinal Cord Stimulation on Gait and Balance in Chronic Low Back Pain Patients

NCT03586882 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-16

No results posted yet for this 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.

Conditions

  • Chronic Low Back Pain
  • Pain in Leg, Unspecified

Interventions

DEVICE

Spinal Cord Stimulation

Stimulation provided by the generator to electrodes on the leads inhibits ascending pain signals, thereby decreasing pain perception.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Texas Back Institute

    lead OTHER

Principal Investigators

  • Ram Haddas, PhD · Texas Back Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2020-02-29
Completion
2020-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03586882 on ClinicalTrials.gov