Cervical Decompression for Myelopathy, Compressive

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic Foundation, Cleveland, OH
Myelopathy, Compressive+4 More
Cervical Decompression - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Can Prophylactic Foraminotomy Prevent C5 Palsy

See full description

Eligible Conditions

  • Myelopathy, Compressive
  • Radiculopathy, Cervical

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Cervical Decompression will improve 1 primary outcome and 7 secondary outcomes in patients with Myelopathy, Compressive. Measurement will happen over the course of Intra-operative measurement.

Intra-operative measurement
Blood loss
Operative time
Preoperative
Preoperative anatomic measurements
Month 3
Back Pain
Leg Pain
Month 3
C5 Palsy
within 90 days postoperatively
Emergency department visit
Readmission to hospital

Trial Safety

Trial Design

2 Treatment Groups

Control Group
1 of 2
Foraminotomy Group
1 of 2
Active Control
Experimental Treatment

This trial requires 480 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cervical Decompression is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Foraminotomy GroupProphylactic bilateral cervical keyhole foraminotomy will be done in addition to their decompression surgery
Control Group
Procedure
Cervical decompression will be done without prophylactic bilateral foraminotomy

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: preoperative, 2 weeks postoperative and 3 months postoperative
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly preoperative, 2 weeks postoperative and 3 months postoperative for reporting.

Who is running the study

Principal Investigator
T. M.
Thomas Mroz, MD
The Cleveland Clinic

Closest Location

Cleveland Clinic Foundation - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Cleveland Clinic patients who have been diagnosed with cervical myelopathy, without radiculopathy, and will undergo posterior cervical decompression involving the C4-C5 interspace between 2016 and 2018. This includes patients undergoing cervical laminoplasty and cervical laminectomy and fusion.

Patient Q&A Section

Can radiculopathy, cervical be cured?

"Radiculopathy can be cured by the administration of a low-dose, short term, intermittent, self-administered treatment with methadone, followed by a maintenance with a methadone-free, low-dose opioid. N-acetylcysteine should be used to provide and maintain sulphate-cysteine as a stabilizer. This self-administered formulation may be a clinically valuable option for treatment of cervical radiculopathy." - Anonymous Online Contributor

Unverified Answer

What are the signs of radiculopathy, cervical?

"The first step in the management of patients complaining of neck pain would include an examination of the upper limbs that can be done in a wheelchair. The signs of radiculopathy can be categorized into three groups based on the severity of the patient's symptoms: cervical, thoracic spinal, and lumbar. All these patients will need to be reassessed within a week and if they don't improve then a referral to a specialist should be considered." - Anonymous Online Contributor

Unverified Answer

What are common treatments for radiculopathy, cervical?

"Both chiropractic and physical therapy are common treatments for radiculopathy. In the opinion of physical therapy practitioners, more research should be conducted to determine the effect of chiropractic on radiculopathy and cervical pain management compared to the effect of physical therapy." - Anonymous Online Contributor

Unverified Answer

What is radiculopathy, cervical?

"Radiculopathy is a chronic, nonspecific pain syndrome involving the nerves that extend from the spinal cord to the extremities. It is a common problem associated with age and workload; it may be due to injury, stenosis, compression, tumor, infection, or other pathology. Symptoms typically begin between 30 and 50 years of age, most commonly after strenuous exertion, prolonged standing, or work with the arms. Radiculopathy in the neck, thoracic, or lumbar areas of the spine can be painful, and in the upper neck can have sensory symptoms. Some patients with cervical radiculopathy will have symptoms that worsen at physical activity or motion. Treatment options include medications and physiotherapy." - Anonymous Online Contributor

Unverified Answer

What causes radiculopathy, cervical?

"Radiculopathy, cervical may be caused by cervical nerve root compression, such as foraminal stenosis and degenerative changes in the foraminal compartment. In an individual with cervical radiculopathy, magnetic resonance can aid in the diagnosis. Magnetic resonance is the study of choice for determining which patients are most likely to respond to cervical epidural corticosteroid injections. Magnetic resonance is an objective and inexpensive technique for obtaining precise images of the cervical spine." - Anonymous Online Contributor

Unverified Answer

How many people get radiculopathy, cervical a year in the United States?

"Nearly 10% of people were affected by cervical radiculopathy during 1 yr. More than half of those affected by radiculopathy were younger than 61 yr." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cervical decompression?

"This small study found that both decompressive procedures (lateral laminotomy) and non-decompressive procedures (aminotomy) caused minor side effects, including short-term fatigue. Side effects occurred more frequently in those women who had previously undergone surgery, or those who were also taking a pain medication or a sedative. This should not prevent us from using these options if they are reasonable when the alternative is to wait for spinal cord dysfunction to set in." - Anonymous Online Contributor

Unverified Answer

Does cervical decompression improve quality of life for those with radiculopathy, cervical?

"There were no significant differences in changes in HRQoL between decompressed and non-decompressed cervical groups. While HRQoL was the most significant clinical effect measure, a significant effect was not seen for improvements in pain." - Anonymous Online Contributor

Unverified Answer

How serious can radiculopathy, cervical be?

"Although painful radiculopathy or cervical radiculopathy can be debilitating, it can resolve if treated soon after onset and if the underlying disease is not complicated by underlying disease. It is an uncommon finding in patients presenting with a [self-retractable disc herniation] but a relatively common diagnosis in patients presenting with a [self-unassisted posterior fusion] for cervical stenosis or spondylotic spinal stenosis. A self-retractable disc herniation can progress rapidly as the [disease burden] increases, but most often stays localized and does not progress to become the typical [cervical radiculopathy]." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for radiculopathy, cervical?

"There was no single criterion predictive of radiologically confirmed cervical radiculopathy. However, we did find that more than 10% of the patients would receive a positive result for a cervical spine radiologic examination when they failed a clinical trial to exclude cervical radiculopathy; thus, clinical trials are not always useless." - Anonymous Online Contributor

Unverified Answer

Is cervical decompression safe for people?

"A large series of consecutive cases over many years found that cervical decompression was well tolerated. Patients with previous surgery of the spine, in addition to those with degenerative cervical disorders, may have a higher risk of surgery and poor long-term outcomes." - Anonymous Online Contributor

Unverified Answer

Has cervical decompression proven to be more effective than a placebo?

"Withdrawal of all pain medication and traction (only in the immediate post surgical period) as necessary, patients treated with cervical decompression were able to reduce their pain levels much quicker and without more serious complications than those treated with a placebo. Moreover, the patients were significantly less satisfied with the use of the sham cervical decompression. Although this study only provides limited statistical support, it provides a basis for further prospective studies to further evaluate the benefits of cervical decompression." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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