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

NCT03586882 | Unknown FDA Device

• 1 other identifier: TBIRF-Medt
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Kinematic Variables Change assessed with human motion capture system

  3-Dimensional Range of Motion (ROM) during the stance and swing phase of the spine, pelvis, hip, knee, ankle, shoulder, and elbow joint angles along with center of mass and head sway and displacement

  Baseline; 6 and 12 weeks after surgery

Secondary Outcomes (4)

• Patient Self-Reported Outcome Assessments Change - Visual analog scale (VAS)

  Baseline; 6 and 12 weeks after surgery

• Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a).

  Baseline; 6 and 12 weeks after surgery

• Patient Self-Reported Outcome Assessments Change - Tampa Scale for Kinesiophobia (TSK).

  Baseline; 6 and 12 weeks after surgery

• Patient Self-Reported Outcome Assessments Change - Minnesota Multiphasic Personality Inventory - 2 - Restructured Form (MMPI-2-RF).

  Baseline; 6 and 12 weeks after surgery

Other Outcomes (3)

• Kinetic Variables Change assessed with human motion capture system

  Baseline; 6 and 12 weeks after surgery

• Spatio-Temporal Variables Change assessed with human motion capture system

  Baseline; 6 and 12 weeks after surgery

• Neuromuscular Variables Change assessed with an Electromyography

  Baseline; 6 and 12 weeks after surgery

Study Arms (2)

Spinal Cord Stimulation Group

EXPERIMENTAL

Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery

Device: Spinal Cord Stimulation

Control Group

NO INTERVENTION

Gait and balance testing to be administered once in healthy subjects

Interventions

Spinal Cord Stimulation DEVICE

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

Spinal Cord Stimulation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• Texas Back Institute: lead
• Medtronic: collaborator

Study Sites (1)

Texas Back Institute

Plano, Texas, 75093, United States

Location

Related Publications (30)

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• Brugliera L, De Luca A, Corna S, Bertolotto M, Checchia GA, Cioni M, Capodaglio P, Lentino C. Spinal Cord Stimulation in Failed Back Surgery Syndrome: Effects on Posture and Gait-A Preliminary 3D Biomechanical Study. Pain Res Manag. 2017;2017:3059891. doi: 10.1155/2017/3059891. Epub 2017 Sep 25.

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  BACKGROUND

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• Block AR, Ben-Porath YS, Marek RJ. Psychological risk factors for poor outcome of spine surgery and spinal cord stimulator implant: a review of the literature and their assessment with the MMPI-2-RF. Clin Neuropsychol. 2013;27(1):81-107. doi: 10.1080/13854046.2012.721007. Epub 2012 Sep 21.

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MeSH Terms

Interventions

Spinal Cord Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ram Haddas, PhD

  Texas Back Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 16, 2018
• Study Start: June 15, 2018
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 16, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)