- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03586882
Effect of Spinal Cord Stimulation on Gait and Balance in Chronic Low Back Pain Patients
Effect of Spinal Cord Stimulation on Gait and Balance in Chronic Low Back Pain Patients With or Without Leg Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low back pain is reported in 75-80% of the population and can significantly influence patients' quality of life. Fortunately, 80-90% of individuals recover from their back pain, whether they receive treatment or not. However, the small percentage of people who do not recover quickly present a costly problem to society and a great challenge to health care providers. Low back pain is the second leading cause for missed days at work, potentially having disability and major socioeconomic consequences. Chronic LBP can also limit flexibility and/or range of motion, which may contribute to an overall decrease in functional capacity, and may ultimately heighten the risk for additional lower extremity injury. Many chronic LBP patients have conditions not amenable to spine surgery, or they have failed to achieve successful outcome with previous spine surgery. For these patients, SCS can be an effective alternative. For example, in a recent demonstration, randomized 100 failed back surgery syndrome (FBSS) patients to either SCS or conventional medical management. At 6 months post-implant, 64% of patients had achieved the 50% reduction in leg pain criterion (vs. 18% of conventional medical management patients). Similarly, North et al. found 52% of patients had achieved at least the 50% reduction in pain when they investigated 171 patients treated with SCS.
SCS uses electrical signals to decrease nociception of impulses arising from painful areas in the spine and or leg. In order to accomplish this goal, SCS involves implantation of a small electrical pulse generator, along with thin leads strategically placed into the epidural space. Stimulation provided by the generator to electrodes on the leads inhibits ascending pain signals, thereby decreasing pain perception. Occasionally, some patients feel a mild paresthesia as a result of the stimulation.
While the effectiveness of SCS on reduction of subjective pain complaints is now well-established, such improvement may not translate into improved functional ability. Previous research found that, for FBSS patients treated with SCS, patients' scores on Oswestry Disability index did not correlate significantly with improvements in function as measured by an accelerometer contained within the stimulator device. Very few studies have examined the effect of SCS on objectively-measured functional abilities, including gait and balance. Those studies suffer from a small sample size and lack of electromyography (EMG) and full body kinematics analyses. Despite that, those studies did find improvement in the spatiotemporal variables (i.e. gait speed, step length and width) while other variables (ground reaction force and trunk motion) were not significantly different using the SCS.
Therefore, the purpose of this study is to evaluate the effect of SCS, on the biomechanics of the lower extremities and spine, using dynamic EMG, video motion capture, and force plate analysis, during gait and static balance testing, in patients with chronic low back and/or leg pain, before and after intervention. In addition this study will compare these same biomechanical parameters found in the chronic low back pain and /or leg pain patients to an asymptomatic control group.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Plano, Texas, United States, 75093
- Texas Back Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Gait and balance testing to be administered once in healthy subjects
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Experimental: Spinal Cord Stimulation Group
Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery
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Stimulation provided by the generator to electrodes on the leads inhibits ascending pain signals, thereby decreasing pain perception.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinematic Variables Change assessed with human motion capture system
Time Frame: Baseline; 6 and 12 weeks after surgery
|
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
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Baseline; 6 and 12 weeks after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Self-Reported Outcome Assessments Change - Visual analog scale (VAS)
Time Frame: Baseline; 6 and 12 weeks after surgery
|
VAS for lower back pain, neck and arm pain, and leg pain.
Scale range from 0 (no pain) - 10 (most pain)
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Baseline; 6 and 12 weeks after surgery
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Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a).
Time Frame: Baseline; 6 and 12 weeks after surgery
|
Scale range from 0 (no pain) - 10 (most pain)
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Baseline; 6 and 12 weeks after surgery
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Patient Self-Reported Outcome Assessments Change - Tampa Scale for Kinesiophobia (TSK).
Time Frame: Baseline; 6 and 12 weeks after surgery
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TSK is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement.
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Baseline; 6 and 12 weeks after surgery
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Patient Self-Reported Outcome Assessments Change - Minnesota Multiphasic Personality Inventory - 2 - Restructured Form (MMPI-2-RF).
Time Frame: Baseline; 6 and 12 weeks after surgery
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The MMPI-2-RF is a 338-item, self-report inventory that assesses personality and psychopathology across 42 substantive scales.
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Baseline; 6 and 12 weeks after surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinetic Variables Change assessed with human motion capture system
Time Frame: Baseline; 6 and 12 weeks after surgery
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Vertical Ground Reaction Forces (GRF)
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Baseline; 6 and 12 weeks after surgery
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Spatio-Temporal Variables Change assessed with human motion capture system
Time Frame: Baseline; 6 and 12 weeks after surgery
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Walking speed
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Baseline; 6 and 12 weeks after surgery
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Neuromuscular Variables Change assessed with an Electromyography
Time Frame: Baseline; 6 and 12 weeks after surgery
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Bilateral peak magnitude during the stance phase
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Baseline; 6 and 12 weeks after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ram Haddas, PhD, Texas Back Institute
Publications and helpful links
General Publications
- Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. 2011 Mar-Apr;11(2):148-53. doi: 10.1111/j.1533-2500.2010.00407.x. Epub 2010 Sep 8.
- Lundberg M, Styf J, Jansson B. On what patients does the Tampa Scale for Kinesiophobia fit? Physiother Theory Pract. 2009 Oct;25(7):495-506. doi: 10.3109/09593980802662160.
- Gee L, Smith HC, Ghulam-Jelani Z, Khan H, Prusik J, Feustel PJ, McCallum SE, Pilitsis JG. Spinal Cord Stimulation for the Treatment of Chronic Pain Reduces Opioid Use and Results in Superior Clinical Outcomes When Used Without Opioids. Neurosurgery. 2019 Jan 1;84(1):217-226. doi: 10.1093/neuros/nyy065.
- Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976). 1987 Sep;12(7):632-44. doi: 10.1097/00007632-198709000-00002.
- Block AR, Gatchel RJ, Deardorff WW, et al. The Psychology of Spine Surgeryed. Washington, D.C.: American Psychological Association, 2003.
- Frey ME, Manchikanti L, Benyamin RM, Schultz DM, Smith HS, Cohen SP. Spinal cord stimulation for patients with failed back surgery syndrome: a systematic review. Pain Physician. 2009 Mar-Apr;12(2):379-97.
- Eldabe S, Kumar K, Buchser E, Taylor RS. An analysis of the components of pain, function, and health-related quality of life in patients with failed back surgery syndrome treated with spinal cord stimulation or conventional medical management. Neuromodulation. 2010 Jul;13(3):201-9. doi: 10.1111/j.1525-1403.2009.00271.x. Epub 2010 Feb 22.
- Agari T, Date I. Spinal cord stimulation for the treatment of abnormal posture and gait disorder in patients with Parkinson's disease. Neurol Med Chir (Tokyo). 2012;52(7):470-4. doi: 10.2176/nmc.52.470.
- Turner JA, Hollingworth W, Comstock BA, Deyo RA. Spinal cord stimulation for failed back surgery syndrome: outcomes in a workers' compensation setting. Pain. 2010 Jan;148(1):14-25. doi: 10.1016/j.pain.2009.08.014. Epub 2009 Oct 28.
- de Andrade DC, Bendib B, Hattou M, Keravel Y, Nguyen JP, Lefaucheur JP. Neurophysiological assessment of spinal cord stimulation in failed back surgery syndrome. Pain. 2010 Sep;150(3):485-491. doi: 10.1016/j.pain.2010.06.001. Epub 2010 Jun 29.
- North RB, Kidd DH, Zahurak M, James CS, Long DM. Spinal cord stimulation for chronic, intractable pain: experience over two decades. Neurosurgery. 1993 Mar;32(3):384-94; discussion 394-5. doi: 10.1227/00006123-199303000-00008.
- Geurts JW, Joosten EA, van Kleef M. Current status and future perspectives of spinal cord stimulation in treatment of chronic pain. Pain. 2017 May;158(5):771-774. doi: 10.1097/j.pain.0000000000000847. No abstract available.
- Goudman L, Smet I, Marien P, De Jaeger M, De Groote S, Huysmans E, Putman K, Van Buyten JP, Buyl R, Moens M. Is the Self-Reporting of Failed Back Surgery Syndrome Patients Treated With Spinal Cord Stimulation in Line With Objective Measurements? Neuromodulation. 2018 Jan;21(1):93-100. doi: 10.1111/ner.12719. Epub 2017 Nov 3.
- Rijken NH, Vonhogen LH, Duysens J, Keijsers NL. The effect of spinal cord stimulation (SCS) on static balance and gait. Neuromodulation. 2013 May-Jun;16(3):244-50; discussion 249-50. doi: 10.1111/j.1525-1403.2012.00512.x. Epub 2012 Sep 25.
- 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.
- Al-Kaisy A, Palmisani S, Smith TE, Pang D, Lam K, Burgoyne W, Houghton R, Hudson E, Lucas J. 10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients With No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study. Neuromodulation. 2017 Jan;20(1):63-70. doi: 10.1111/ner.12563. Epub 2016 Dec 26.
- Sumner LA, Lofland K. Spinal cord stimulation: Subjective pain intensity and presurgical correlates in chronic pain patients. Chronic Illn. 2014 Sep;10(3):157-66. doi: 10.1177/1742395313504233. Epub 2013 Sep 18.
- Wolter T, Kieselbach K. Cervical spinal cord stimulation: an analysis of 23 patients with long-term follow-up. Pain Physician. 2012 May-Jun;15(3):203-12.
- Vaughan CL, Davis BL, O'Conner JC. Dynamics of Human Gait. 2nd ed. Cape Town, South Africa: Kiboho Publishers, 1999.
- Arumugam A, Milosavljevic S, Woodley S, Sole G. Effects of external pelvic compression on form closure, force closure, and neuromotor control of the lumbopelvic spine--a systematic review. Man Ther. 2012 Aug;17(4):275-84. doi: 10.1016/j.math.2012.01.010. Epub 2012 Mar 2.
- Lethem J, Slade PD, Troup JD, Bentley G. Outline of a Fear-Avoidance Model of exaggerated pain perception--I. Behav Res Ther. 1983;21(4):401-8. doi: 10.1016/0005-7967(83)90009-8. No abstract available.
- Miller RP, Kori S, Todd D. The Tampa Scale: a measure of kinesiophobia. Clin J Pain 1991;7:51-2.
- Lundberg MKE, Styf J, Carlsson SG. A psychometric evaluation of the Tampa Scale for Kinesiophobia - from a physiotherapeutic perspective. Physiotherapy Theory and Practice 2004;20:121-33.
- Bunketorp L, Carlsson J, Kowalski J, Stener-Victorin E. Evaluating the reliability of multi-item scales: a non-parametric approach to the ordered categorical structure of data collected with the Swedish version of the Tampa Scale for Kinesiophobia and the Self-Efficacy Scale. J Rehabil Med. 2005 Sep;37(5):330-4. doi: 10.1080/16501970510036411.
- Wertli MM, Rasmussen-Barr E, Weiser S, Bachmann LM, Brunner F. The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review. Spine J. 2014 May 1;14(5):816-36.e4. doi: 10.1016/j.spinee.2013.09.036. Epub 2013 Oct 18. Erratum In: Spine J. Aug 1;14(8):a18.
- Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
- Rainville J, Smeets RJ, Bendix T, Tveito TH, Poiraudeau S, Indahl AJ. Fear-avoidance beliefs and pain avoidance in low back pain--translating research into clinical practice. Spine J. 2011 Sep;11(9):895-903. doi: 10.1016/j.spinee.2011.08.006. Epub 2011 Sep 9.
- Ben-Porath YS, Tellegen A. MMPI-2-RF Manual for Administration, Scoring, and Interpretationed. Minneapolis, MN: University of Minnesota Press, 2008.
- Block AR, Marek RJ, Ben-Porath YS, Kukal D. Associations Between Pre-Implant Psychosocial Factors and Spinal Cord Stimulation Outcome: Evaluation Using the MMPI-2-RF. Assessment. 2017 Jan;24(1):60-70. doi: 10.1177/1073191115601518. Epub 2015 Aug 28.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBIRF-Medt
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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