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

Status unconfirmed · Not applicable

Conditions studied: Chronic Low Back Pain, Pain in Leg, Unspecified

In brief

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.

Key facts

Study ID

NCT03586882

Run by

Texas Back Institute

People needed

100

Starts

2018-06-15

Expected to finish

2020-06-01

Last updated by the study team

2018-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 years and older
• Considered to be a candidate for SCS
• Leg pain and/or LBP lasting than 6 months.
• Therapy consists of a short trial with a percutaneous implantation of neurostimulator electrode(s) in the epidural space for assessing a candidate's suitability for ongoing treatment with a permanent surgically implanted SCS. Performance and documentation of an effective trial is required for consideration of permanent SCS.
• The implantation of the stimulator is used only as a late or last resort for patients with chronic intractable pain.
• Other treatment modalities (pharmacologic, surgical, physical/and psychological therapies) have been tried and did not prove satisfactory; were judged unsuitable, or were contraindicated for the patient.
• Patient has undergone appropriate psychological screening, including psychometric testing using the Minnesota Multiphasic Personality Inventory-2 Restructured Form (MMPI-2-RF), and diagnosis by a multidisciplinary team before implantation; to include patient education, discussion and disclosure including an extensive discussion of the risk and benefits of therapy.
• All the facilities, equipment, and professional support personnel required for the proper diagnosis, treatment, training, and follow-up of the patient are available.
• All trials which proceed to permanent implantation should demonstrate adequate documentation to support the decision. A successful trial should be associated with at least 50% reduction of target pain, a reduction of analgesic medications and show some element of functional improvement (i.e. sitting, standing and walking tolerances).
• Able to ambulate without assistance and stand without assistance with eyes open for a minimum of 10 seconds
• Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-operative follow-up

You may not qualify if…

• Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
• BMI higher than 35
• Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
• Major trauma to the pelvis
• Pregnant or wishing to become pregnant during the study
• Previous spinal surgery that would preclude the safe percutaneous or permanent implantation of the SCS leads
• Previous history of spinal infection either iatrogenic or denovo
• Previous SCS attempts either successful or not

Where it is running

• Texas Back Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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