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Cervical Spondylotic MyelopathyNCT03513679

Gait in Adult Patients With Cervical Spondylotic Myelopathy

A study testing Surgical intervention in people with Cervical Spondylotic Myelopathy, run by Texas Back Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of cervical decompression surgery on the biomechanics of the lower extremities and spine during balance and gait in patients with cervical spondylotic myelopathy (CSM), before and after surgical intervention, and compare these parameters to an asymptomatic control… Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
Conditions the study is for
Cervical Spondylotic Myelopathy
What is being tested?
Surgical intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
22 Mar 2018to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 30 years and older
  • Diagnosis of CSM with correlative imaging studies (MRI or CT-myelogram)
  • Able to ambulate without assistance and stand without assistance with participant 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

Who cannot join

  • History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion)
  • 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 (beside cervical spondylotic myelopathy), diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
  • Usage of blood thinners
  • Pregnant or wishing to become pregnant during the study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Back Institute

    Plano, Texas, 75093

Other trials in United States

About this study

Official title: Effect of Cervical Decompression Surgery on Neuromuscular Control and Kinematics During Gait in Adult Patients With Cervical Spondylotic Myelopathy

The purpose of this study is to evaluate the effect of cervical decompression surgery on the biomechanics of the lower extremities and spine during balance and gait in patients with cervical spondylotic myelopathy (CSM), before and after surgical intervention, and compare these parameters to an asymptomatic control group. To test our hypothesis that cervical decompression will improve preexisting gait disturbance, a gait analysis using dynamic surface EMG, video motion capture, and force plate analysis will be used. Patients 30 to 70 years old will be eligible for the study. Thirty subjects diagnosed with symptomatic CSM and are deemed appropriate surgical candidates, along with 30 healthy subjects with no spine pathology, will be enrolled in this study. Exclusion criteria include any history of previous lumbar/thoracic surgery or lower extremity surgery, BMI greater than 35, or currently pregnant. Each subject from the surgical group will be evaluated on 3 different occasions: 1) 1 week before surgery, 2) 3 months postoperative, and 3) 12 months postoperative. Control subject will only be evaluated once. Bilateral trunk and lower extremity neuromuscular activity will be measured during a full gait cycle using dynamic surface EMG measurements. Human video motion capture cameras will collect lumbar spine and lower and upper extremity joint angles. Ground reaction forces (GRFs) will be collected from a 5 foot stretch of force platforms in order to define a full gait cycle.

Read the detailed description

Cervical spondylotic myelopathy (CSM) is a neurologic condition resulting from spinal cord compression caused by degenerative narrowing of the cervical spinal canal. CSM is most common after the age of 50 years, but the age of onset is variable depending on the degree of congenital spinal canal narrowing. Progressive degenerative changes in the cervical spine, such as disc bulges or herniations, facet hypertrophy, ligamentum flavum thickening, and degenerative vertebral spondylolisthesis, can all contribute to progressive spinal cord compression. The end result is chronic compression of the spinal cord and/or nerve roots leading to impaired blood flow, which can result in frank damage within the spinal cord itself. CSM is characterized by a wide variety of clinical presentations, which can include neck pain, numbness or weakness in the extremities, hand clumsiness, and, classically, gait disturbances. This typically manifests as difficulty with balance, but patients with more advanced myelopathy can also develop a stiff, spastic gait.

Surgical treatment of CSM revolves around decompressing the spinal cord, either with or without concurrent fusion. Many surgical strategies have been proposed. Anterior surgical approaches include anterior cervical discectomy and fusion or anterior corpectomy and fusion. Posterior surgical approaches include laminectomy with or without fusion, or laminoplasty. The choice of surgical approach is specific to each patient based upon the extent and location of the pathology, the presence or absence of deformity or spinal instability, the sagittal alignment of the spine, the presence or absence of ossification of the posterior longitudinal ligament (OPLL), as well as other patient co-morbidity factors and surgeon preference. While there may be some debate as to when patients with radiographic cervical stenosis should undergo decompressive surgery, most surgeons would agree on surgery for patients with moderate or severe clinical myelopathy.

Altered gait is frequently seen with CSM, and has been reported to be improved by surgical intervention. A stiff or spastic gait is also characteristic of CSM in its later stages. Many clinical studies have determined that patients with CSM have a slower gait speed, prolonged double support duration, and reduced cadence compared to healthy controls.Previous studies also identified reduced knee flexion during swing in the early stages of the disease, and, in more severe cases, decreased ankle plantar flexion at the terminal stance and reduced knee flexion during loading response.

Upright stance and body stability depends on the vestibular, visual, and somatosensory systems.These systems contribute to the maintenance of postural control. The spinal cord, particularly the dorsal column, is an integral part of the somatosensory system.The dorsal columns relay the position and vibration sensations as well as play an important role in maintaining postural stability and conveying sensory information such as deep sensations to the lower limbs.When the dorsal column of the spinal cord is compressed, the functions of vibration sense, deep sensibility, and joint position sense are lost. CSM patients were found to have impaired knee proprioception when using electrogoniometer.22 A damaged spinal cord causes impaired body balance because of proprioceptive loss, and patients develop ataxia in the lower limbs.

Jean Dubousset, first introduced the concept of the cone of economy and balance (COE) in 1994. The COE refers to a stable region of standing posture. The fundamental assumption is that swaying outside one's individual cone challenges the balance mechanisms and expends critical energy. Balance is defined as the ability of the human body to maintain its center of mass within the base of support with minimal postural sway. Sway is the movement of the COM in the horizontal plane when a person is standing in a static position. Balance efficiency is defined as the ability of the patients to maintain their COM within the COE with minimal sway and energy expenditure.Maintenance of balance requires coordination between the sensorineural and musculoskeletal systems. Very few studies have looked at functional balance in CSM patients. These studies used a stabilometer to measure center of gravity. During a 30 seconds balance test with closed eyes, CSM patients swayed significantly more and had greater postural instability compared to healthy controls. Neither of those studies reported on neuromuscular activity during a functional balance test. Haddas et al.was first to introduce a method to objectively quantify the COE and neuromuscular energy expenditure during a dynamic balance test.

There is very little literature investigating the effect of surgical intervention on a CSM patient's balance and gait using human motion analysis both before and after surgery. In fact, there have not been any studies examining how surgical intervention for CSM can improve patients' balance and gait utilizing objective neuromuscular data as well as full body kinematic analysis. Additionally, none of the previous studies have been able to validate self-reported pain and functional outcome measures utilizing a human motion capture system and EMG.

This study explores the effect of CSM on human balance and gait and will utilize kinematic balance and gait analyses to examine the dynamic range of motion of the spine and lower extremities, along with neuromuscular data from surface EMG to precisely define the timing and degree of spine and lower extremity muscle activation and peak activity, as well as measurements of ground reaction forces throughout the gait cycle. All of this will be compared pre- and post-operatively and also with a healthy control group in order to determine the extent to which CSM affects the biomechanics of and neuromuscular control during balance and gait and how this changes after surgical intervention. We will also be able to correlate these objective measures with patient self-reported pain and function based on commonly used outcome instruments.

In summary, the purpose of this study is to explore the level of functional compromise, both objectively and with patient-reported outcome measures, in patients with CSM and to quantify the possible benefit of surgical intervention on the biomechanics and neuromuscular control of the spine and lower extremities as evaluated by balance and gait analyses using dynamic EMG, video motion capture, force plate analysis, and validated patient-reported outcome metrics.

Being tested
Surgical intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical interventionProcedure or surgery

    Surgery to decompress the spinal cord, either with or without concurrent fusion

Study groups in NCT03513679
Study groupRoleWhat they receive
Surgical GroupExperimentalGait and balance testing as well as self-reported outcome assessments to be administered before and after surgery
Receives: Procedure: Surgical intervention
Control GroupNo interventionGait and balance testing to be administered once in healthy subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 CoM and head sway and displacement

    Measured: Baseline; 3 and 12 months after surgery

  2. Kinetic Variables Change assessed with human motion capture system

    Vertical Ground Reaction Forces (GRF)

    Measured: Baseline; 3 and 12 months after surgery

  3. Neuromuscular Variables Change assessed with an Electromyography

    Bilateral peak magnitude during the stance phase

    Measured: Baseline; 3 and 12 months after surgery

  4. Spatio-Temporal Variables Change assessed with human motion capture system

    Walking speed

    Measured: Baseline; 3 and 12 months after surgery

Secondary outcomes (4)
  1. Patient Self-Reported Outcome Assessments Change

    Visual analog scale (VAS) for lower back pain, neck and arm pain, and leg pain. Scale range from 0 (no pain) - 10 (most pain)

    Measured: Baseline; 3 and 12 months after surgery

  2. Patient Self-Reported Outcome Assessments Change

    Oswestry Disability Index (ODI, version 2.1.a). Scale range from 0 (no pain) - 10 (most pain)

    Measured: Baseline; 3 and 12 months after surgery

  3. Patient Self-Reported Outcome Assessments Change

    Neck Disability Index (NDI). Scale range from 0 (no pain) - 10 (most pain)

    Measured: Baseline; 3 and 12 months after surgery

  4. Patient Self-Reported Outcome Assessments Change

    Modified Japanese Orthopaedic Association scale (mJOA). Scale range from 0 (no pain) - 18 (most pain)

    Measured: Baseline; 3 and 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2018
  2. Study start22 Mar 2018
  3. Primary completion1 Mar 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03513679
Sponsor's protocol ID
TBIRF-CSRS
Status last verified
Apr 2018
First submitted
14 Feb 2018
Last updated
1 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Portney LG, Watkins MP. Foundation of clinical research: applications to practiceed. Upper Saddle River, New Jersy: Julie Levin Alexander, 2009.

  • Rhee JM, Heflin JA, Hamasaki T, Freedman B. Prevalence of physical signs in cervical myelopathy: a prospective, controlled study. Spine (Phila Pa 1976). 2009 Apr 20;34(9):890-5. doi: 10.1097/BRS.0b013e31819c944b.

    PubMed 19352222
  • Emery SE. Cervical spondylotic myelopathy: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Nov-Dec;9(6):376-88. doi: 10.5435/00124635-200111000-00003.

    PubMed 11767723
  • Rao R. Neck pain, cervical radiculopathy, and cervical myelopathy: pathophysiology, natural history, and clinical evaluation. J Bone Joint Surg Am. 2002 Oct;84(10):1872-81. doi: 10.2106/00004623-200210000-00021. No abstract available.

    PubMed 12377921
  • Salvi FJ, Jones JC, Weigert BJ. The assessment of cervical myelopathy. Spine J. 2006 Nov-Dec;6(6 Suppl):182S-189S. doi: 10.1016/j.spinee.2006.05.006.

    PubMed 17097537
  • Eskander MS, Aubin ME, Drew JM, Eskander JP, Balsis SM, Eck J, Lapinsky AS, Connolly PJ. Is there a difference between simultaneous or staged decompressions for combined cervical and lumbar stenosis? J Spinal Disord Tech. 2011 Aug;24(6):409-13. doi: 10.1097/BSD.0b013e318201bf94.

    PubMed 21150658
  • Geck MJ, Eismont FJ. Surgical options for the treatment of cervical spondylotic myelopathy. Orthop Clin North Am. 2002 Apr;33(2):329-48. doi: 10.1016/s0030-5898(02)00002-0.

    PubMed 12389279
  • Komotar RJ, Mocco J, Kaiser MG. Surgical management of cervical myelopathy: indications and techniques for laminectomy and fusion. Spine J. 2006 Nov-Dec;6(6 Suppl):252S-267S. doi: 10.1016/j.spinee.2006.04.029.

    PubMed 17097545
  • Kadanka Z, Mares M, Bednanik J, Smrcka V, Krbec M, Stejskal L, Chaloupka R, Surelova D, Novotny O, Urbanek I, Dusek L. Approaches to spondylotic cervical myelopathy: conservative versus surgical results in a 3-year follow-up study. Spine (Phila Pa 1976). 2002 Oct 15;27(20):2205-10; discussion 2210-1. doi: 10.1097/01.BRS.0000029255.77224.BB.

    PubMed 12394893
  • Emery SE, Bohlman HH, Bolesta MJ, Jones PK. Anterior cervical decompression and arthrodesis for the treatment of cervical spondylotic myelopathy. Two to seventeen-year follow-up. J Bone Joint Surg Am. 1998 Jul;80(7):941-51. doi: 10.2106/00004623-199807000-00002.

    PubMed 9697998
  • Liu X, Min S, Zhang H, Zhou Z, Wang H, Jin A. Anterior corpectomy versus posterior laminoplasty for multilevel cervical myelopathy: a systematic review and meta-analysis. Eur Spine J. 2014 Feb;23(2):362-72. doi: 10.1007/s00586-013-3043-7. Epub 2013 Oct 5.

    PubMed 24097230
  • Rhee JM, Riew KD, Spivak JM, et al. Cervical spondylotic myelopathy: including ossification of the posterior longitudinal ligamented. Rosemont, IL, 2006.

  • Malone A, Meldrum D, Bolger C. Gait impairment in cervical spondylotic myelopathy: comparison with age- and gender-matched healthy controls. Eur Spine J. 2012 Dec;21(12):2456-66. doi: 10.1007/s00586-012-2433-6. Epub 2012 Jul 24.

    PubMed 22825630
  • Kuhtz-Buschbeck JP, Johnk K, Mader S, Stolze H, Mehdorn M. Analysis of gait in cervical myelopathy. Gait Posture. 1999 Jul;9(3):184-9. doi: 10.1016/s0966-6362(99)00015-6.

    PubMed 10575079
  • Singh A, Choi D, Crockard A. Use of walking data in assessing operative results for cervical spondylotic myelopathy: long-term follow-up and comparison with controls. Spine (Phila Pa 1976). 2009 May 20;34(12):1296-300. doi: 10.1097/BRS.0b013e3181a09796.

    PubMed 19412138

Questions about this trial

What is this clinical trial studying?

A study testing Surgical intervention in people with Cervical Spondylotic Myelopathy, run by Texas Back Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kinematic Variables Change assessed with human motion capture system (time frame: Baseline; 3 and 12 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03513679, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.

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