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

NCT ID: NCT03586882

Last Updated: 2018-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2020-06-30

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.

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.

Conditions

Chronic Low Back Pain; Pain in Leg, Unspecified

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Spinal Cord Stimulation Group

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

Group Type: EXPERIMENTAL

Spinal Cord Stimulation

Intervention Type: DEVICE

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

Control Group

Gait and balance testing to be administered once in healthy subjects

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Spinal Cord Stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18 years and older

2. Considered to be a candidate for SCS

1. Leg pain and/or LBP lasting than 6 months.

2. 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.

3. The implantation of the stimulator is used only as a late or last resort for patients with chronic intractable pain.

4. 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.

5. 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.

6. All the facilities, equipment, and professional support personnel required for the proper diagnosis, treatment, training, and follow-up of the patient are available.

7. 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).

3. Able to ambulate without assistance and stand without assistance with eyes open for a minimum of 10 seconds

4. 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

1. Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)

2. BMI higher than 35

3. Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance

4. Major trauma to the pelvis

5. Pregnant or wishing to become pregnant during the study

6. Previous spinal surgery that would preclude the safe percutaneous or permanent implantation of the SCS leads

7. Previous history of spinal infection either iatrogenic or denovo

8. Previous SCS attempts either successful or not

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Texas Back Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ram Haddas, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Back Institute

Locations

Texas Back Institute

Plano, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29538696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2961080 (View on PubMed)

Block AR, Gatchel RJ, Deardorff WW, et al. The Psychology of Spine Surgeryed. Washington, D.C.: American Psychological Association, 2003.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19305486 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21371254 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21992833 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22850494 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19875232 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20591571 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8455763 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28106667 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29105225 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23009103 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29147083 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28025843 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24048947 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22622904 (View on PubMed)

Vaughan CL, Davis BL, O'Conner JC. Dynamics of Human Gait. 2nd ed. Cape Town, South Africa: Kiboho Publishers, 1999.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 22386280 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6626110 (View on PubMed)

Miller RP, Kori S, Todd D. The Tampa Scale: a measure of kinesiophobia. Clin J Pain 1991;7:51-2.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19925172 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16208869 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24412032 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8455963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21907633 (View on PubMed)

Ben-Porath YS, Tellegen A. MMPI-2-RF Manual for Administration, Scoring, and Interpretationed. Minneapolis, MN: University of Minnesota Press, 2008.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 26318387 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22998432 (View on PubMed)

Other Identifiers

TBIRF-Medt

Identifier Type: -

Identifier Source: org_study_id