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CerviFit® Home Strengthening and Reconditioning Program Study

Jeffrey Steinberg, MD; jsteinberg@fcneurology.net

7/01/2020

People with work related injuries are the most difficult to treat and tend to have a less favorable outcome compared to the general population. There are several factors for this with the most obvious being patient motivation (or the lack thereof). Other contributing causes include time constraint, delay in initiating treatment, the quality/consistency of physical therapy, and poor coordination of care betweenproviders and the third-party payors.

Neck and upper body pain, including headache and shoulder pain, represent a substantial number of those injured at work. Though the absolute number may not represent the highest % of those injured (20% approx.) based on a 2019 Zurich insurance study comprised of a formal analysis of more than 6,000 yearly worker injury claims in the healthcare industry, representing about $30 million in annual claim payments (entitled The Benchmark Study of Healthcare Workers’ Compensation Claims Statistics, it tends to be the most protracted in terms of treatment days and missed workdays. The cause for poor treatment outcome is the current treatment modalities are not designed to properly correct the underlying pathophysiological cause of the injury. Correlating this with the fact that 15% of all work-related injuries account for 85% of the costs, affirms that the CerviFit Home Program is both the medical treatment of choice and the financially prudent course of action for this patient type.

The CerviFit Strengthening and Reconditioning Program is unique in its design and treatment platform. By addressing the underlying fundamental cause of these pain types, it improves treatment outcome, motivates patient compliance, improves functionality, and is cost effective to the insurance carrier.

Clinical Criteria for Entry:

All the enrolled WC patients were referred to the neurologist either by a WC PCP or a specialist (typically from an Orthopedist, occasionally the Pain Interventionalist) after failing traditional conservative medical care such as physical therapy and medication.

Those that were evaluated by at least one specialist prior to the neurological referral had additional treatments such as a change in medications, renewal of therapy, and/or invasive procedures such as cervical epidurals or shoulder injections. Interestingly, none of the patients were seen in the acute phase of the injury, i.e., not before 3 months post event.

The breakdown of patients:

• 24 Males,20 Females

• Male Population (Yrs. old) 30% (18-32), 60% (33-47), 10% (50-65)

• Female Population (Yrs. old) 35% (18-32) 55% (33-49) 10% (49-72)

Though the chief complaints were neck and upper body pain, there were associated pain symptoms in their shoulder(s) and head and sensory complaints in the extremity(ies). Over three quarters had radicular symptoms at the onset of their injuries (sensory loss, pain, weakness) into one or both upper extremities. The most common reason for the referral from the treating physician to the neurologist was for the diagnosis of headaches. Other diagnoses were neck pain, radiculopathy, and/or vertigo.

Any combination of these symptoms, with an abnormal examination were considered appropriate candidates for the CerviFit Home program.

The examination had to demonstrate a decrease in the ROM of the cervical spine by more than 15 degrees in at least 2 out of the 4 planes (typically there were restricted movements in all four movements to varying degrees) Other findings included asymmetrical weakness of the neck muscles, decreased ROM of one or both shoulders, multiple trigger points bilaterally, and neurological deficits (such as radiculopathy, entrapment brachial plexopathies, CTS, dystonia, occipital neuralgia).

Objective Testing:

Once approved for the CerviFit Home Program each patient’s baseline tensile neck strength was measured by a handheld dynamometer (pounds per square inches) with a custom designed head strap fitted with a D-Ring for secure attachement. The neck movements recorded were:

1. Flexion

2. Extension

3. Left lateral extension

4. Right lateral extension

Part of the initial evaluation with the CerviFit Home Program included rating their pain via the VAS (Visual Analog Scale) and their functional limitations based on the Oswestry Neck Disability Index (see the attached questionnaire). Of note, all patients had an MRI of the Cervical spine prior to starting the CerviFit program, but the specific pathology on the imaging study was not tabulated with the other indicators, nor were any neuroimaging parameters established. However, any type of cervical spinal fracture, spinal cord compression, or recent cervical surgery were excluded. The caveat with the latter is the patients with preexisting spinal surgeries were not considered absolute contraindications. If these patients already had physical therapy during their course of treatment, then they were eligible for the CerviFit Program. Those who had surgery subsequent to the CerviFit program, resumed the program once they were cleared by the surgeon to initiate post op physical therapy.

Electrodiagnostic studies were performed on two thirds of those enrolled, (several

had this study performed at an outside facility prior to the referral). The findings

varied from negative to cervical radiculopathy. These results were not used as a

criterion for the CerviFit Home Reconditioning and Strengthening Program so no

determination could be made about the effectiveness of the Program regarding the

neuropathic abnormalities.

Clinical Data:

Over the course of the 10 Week program, the patients were evaluated in the office every two weeks. In addition to the standard clinical evaluation, the physician utilized the VAS for pain, the Oswestry Disability Neck Index, and the dynamometer. Of the 44 patients, 86% or (38) were compliant with the 10-week treatment program. Two (2) patients had missed or failed to show-up for their follow-up clinical evaluation on a consistent basis, thus rendering them non-compliant. Three had inconsistent results (in conjunction with other clinical factors) and were deemed malingerers. One discontinued use of the program to undergo Chemotherapy for Breast Cancer. One discontinued to undergo Cervical arthroplasty but restarted the program in the post-acute phase of their rehabilitation.

• 30% of the patients had one or more level disc protrusion as a result of the injury

• 35% had preexisting chronic pathological changes in the cervical spine or in the

shoulder

• 64% of the patient population studied had cervicogenic headaches and 5% had

exacerbations of preexisting migraines

• 52% had shoulder pain, typically diagnosed with Impingement Syndrome.

• All had asymmetric weakness of the cervical neck muscles with weakness in all

planes of movement per the Dynamometer.

Of those patients who were compliant with the program, all had improvement clinically. Their overall cervicogenic pain improved based on their VAS (Visual Analog Scale) and improved functionality per the Oswestry Index. Clinical Results at the end of the Program.

• Overall, there was a 28% improvement in tensile strength in the compliant

patients with 57% (25 people) experiencing an average 40% improvement.

• The average reduction on The Oswestry Index Scale was 8 points with 70%

converted from moderate to mild disability.

• The VAS was decreased from 7 to 3.5 on average, though the maximum pain

during an exacerbation was reduced by 2 points in the majority of patients.

• All the compliant patients continued to use the CerviFit device at the completion

of the study. Most stayed at the 1-to-2-pound weights.

• There were no injuries or complications with the device. Initially a few had

recurrence of their pain as they did not understand the principle, technique, or

follow the proper exercise instructions of the program.

Conclusion:

All the enrolled patients in the CerviFit Program had been refractory to the standard treatment currently practiced by the medical community in the Workman’s Compensation arena. The number of patients who had a positive response, and their success rate, was higher than anticipated. The reason for this was multifactorial. The patients had input and control in their care, received tangible feedback every two weeks over the course of the program, and expressed improved quality of life as documented by the Oswestry Index scale. Additionally, Workman’s Compensation insurance carriers have the ability to discharge a patient if noncompliance is documented. The physician was able to confirm noncompliance in four patients and all treatment was immediately terminated.

A larger study is needed to determine what factors influence clinical outcome such as underlining pathology, job description and time of onset to treatment with the overall goals of reducing the number of medications such as opiates, and the recurrence rate of exacerbations. Other diagnostic tests such as electrodiagnostic studies, X rays, and neuroimages and neuropsychological evaluations need to be included to determine which abnormalities are predictors of outcome and functionality.

Researcher Bio: Dr. Jeffrey Steinberg is a board-certified Neurologist with over 25 years of clinical experience. Dr. Steinberg completed his residency at Keiser Permeate Los Angeles University of California, Davis, an interventional pain fellowship at University of Louisville, (Veterans Administration) and neurophysiology/ sleep fellowship at Emory University. Dr. Steinberg is the founder of the Headache and Pain center of South Florida with a focus on patient-centric care.

©2020 Jeffrey Steinberg, MD; No part may be reproduced without first obtaining

written permission from the author.