By Thomas A. Gionis, MD, JD, MBA, MHA, FICS, FRCS, and Eric Groteke, DC, CCIC
The outcome of a clinical study evaluating the effect of nonsurgical intervention on symptoms of spine patients with herniated and degenerative disc disease is presented.
This clinical outcomes study was performed to evaluate the effect of spinal decompression on symptoms and physical findings of patients with herniated and degenerative disc disease. Results showed that 86% of the 219 patients who completed the therapy reported immediate resolution of symptoms, while 84% remained pain-free 90 days post-treatment. Physical examination findings showed improvement in 92% of the 219 patients, and remained intact in 89% of these patients 90 days after treatment. This study shows that disc disease—the most common cause of back pain, which costs the American health care system more than $50 billion annually—can be cost-effectively treated using spinal decompression. The cost for successful non-surgical therapy is less than a tenth of that for surgery. These results show that biotechnological advances of spinal decompression reveal promising results for the future of effective management of patients with disc herniation and degenerative disc diseases. Long-term outcome studies are needed to determine if non-surgical treatment prevents later surgery, or merely delays it.
With
the recent advances in biotechnology, spinal decompression has evolved into
a cost-effective nonsurgical treatment for herniated and degenerative spinal
disc disease, one of the major causes of back pain. This nonsurgical treatment
for herniated and degenerative spinal disc disease works on the affected spinal
segment by significantly reducing intradiscal pressures.1 Chronic low back
pain disability is the most expensive benign condition that is medically treated
in industrial countries. It is also the number one cause of disability in persons
under age 45. After 45, it is the third leading cause of disability.2 Disc
disease costs the health care system more than $50 billion a year.
The intervertebral disc is made up of sheets of fibers that form a fibrocartilaginous structure, which encapsulates the inner mucopolysaccharide gel nucleus. The outer wall and gel act hydrodynamically. The intrinsic pressure of the fluid within the semirigid enclosed outer wall allows hydrodynamic activity, making the intervertebral disc a mechanical structure.3 As a person utilizes various normal ranges of motion, spinal discs deform as a result of pressure changes within the disc.4 The disc deforms, causing nuclear migration and elongation of annular fibers. Osteophytes develop along the junction of vertebral bodies and discs, causing a disease known as spondylosis. This disc narrows from the alteration of the nucleus pulposus, which changes from a gelatinous consistency to a more fibrous nature as the aging process continues. The disc space thins with sclerosis of the cartilaginous end plates and new bone formation around the periphery of the contiguous vertebral surfaces. The altered mechanics place stress on the posterior diarthrodial joints, causing them to lose their normal nuclear fulcrum for movement. With the loss of disc space, the plane of articulation of the facet surface is no longer congruous. This stress results in degenerative arthritis of the articular surfaces.
This is especially important in occupational repetitive injuries, which make up a majority of work-related injuries. When disc degeneration occurs, the layers of the annulus can separate in places and form circumferential tears. Several of these circumferential tears may unite and result in a radial tear where the material may herniate to produce disc herniation or prolapse. Even though a disc herniation may not occur, the annulus produces weakening, circumferential bulging, and loss of intervertebral disc height. As a result, discograms at this stage usually reveal reduced interdiscal pressure.
The early changes that have been identified in the nucleus pulposus and annulus fibrosis are probably biomechanical and relate to aging. Any additional trauma on these changes can speed up the process of degeneration. When there is a discogenic injury, physical displacement occurs, as well as tissue edema and muscle spasm, which increase the intradiscal pressures and restrict fluid migration.6 Additionally, compression injuries causing an endplate fracture can predispose the disc to degeneration in the future.
The alteration of normal kinetics is the most prevalent cause of lower back pain and disc disruption and thus it is vital to maintain homeostasis in and around the spinal disc; Yong-Hing and Kirkaldy-Willis7 have correlated this degeneration to clinical symptoms. The three clinical stages of spinal degeneration include:
Stage of Dysfunction. There is little pathology and symptoms are subtle or absent. The diagnosis of Lumbalgia and rotatory strain are commonly used.
Stage of Instability. Abnormal movement of the motion segment of instability exists and the patient complains of moderate symptoms with objective findings. Conservative care is used and sometimes surgery is indicated.
Stage of Stabilization. The third phase where there are severe degenerative changes of the disc and facets reduce motion with likely stenosis.
Spinal decompression has been shown to decompress the disc space, and in the clinical picture of low back pain is distinguishable from conventional spinal traction.8,9 According to the literature, traditional traction has proven to be less effective and biomechanically inadequate to produce optimal therapeutic results.8-11 In fact, one study by Mangion et al concluded that any benefit derived from continuous traction devices was due to enforced immobilization rather than actual traction.10 In another study, Weber compared patients treated with traction to a control group that had simulated traction and demonstrated no significant differences.11 Research confirms that traditional traction does not produce spinal decompression. Instead, decompression, that is, unloading due to distraction and positioning of the intervertebral discs and facet joints of the lumbar spine, has been proven an effective treatment for herniated and degenerative disc disease, by producing and sustaining negative intradiscal pressure in the disc space. In agreement with Nachemon’s findings and Yong-Hing and Kirkaldy-Willis,1 spinal decompression treatment for low back pain intervenes in the natural history of spinal degeneration.7,12 Matthews13 used epidurography to study patients thought to have lumbar disc protrusion. With applied forces of 120 pounds x 20 minutes, he was able to demonstrate that the contrast material was drawn into the disc spaces by osmotic changes. Goldfish14 speculates that the degenerated disc may benefit by lowering intradiscal pressure, affecting the nutritional state of the nucleus pulposus. Ramos and Martin8 showed by precisely directed distraction forces, intradiscal pressure could dramatically drop into a negative range. A study by Onel et al15 reported the positive effects of distraction on the disc with contour changes by computed tomography imaging. High intradiscal pressures associated with both herniated and degenerated discs interfere with the restoration of homeostasis and repair of injured tissue.
Biotechnological advances have fostered the design of Food and Drug Administration-approved ergonomic devices that decompress the intervertebral discs. The biomechanics of these decompression/reduction machines work by decompression at the specific disc level that is diagnosed from finding on a comprehensive physical examination and the appropriate diagnostic imaging studies. The angle of decompression to the affected level causes a negative pressure intradiscally that creates an osmotic pressure gradient for nutrients, water, and blood to flow into the degenerated and/or herniated disc thereby allowing the phases of healing to take place.
This clinical outcomes study, which was performed to evaluate the effect of spinal decompression on symptoms of patients with herniated and degenerative disc disease, showed that 86% of the 219 patients who completed therapy reported immediate resolution of symptoms, and 84% of those remained pain-free 90 days post-treatment. Physical examination findings revealed improvement in 92% of the 219 patients who completed the therapy.
The study group included 229 people, randomly chosen from 500 patients who had symptoms associated with herniated and degenerative disc disease that had been ongoing for at least 4 weeks. Inclusion criteria included pain due to herniated and bulging lumbar discs that is more than 4 weeks old, or persistent pain from degenerated discs not responding to 4 weeks of conservative therapy. All patients had to be available for 4 weeks of treatment protocol, be at least 18 years of age, and have an MRI within 6 months. Those patients who had previous back surgery were excluded. Of note, 73 of the patients had experienced one to three epidural injections prior to this episode of back pain and 22 of those patients had epidurals for their current condition. Measurements were taken before the treatments began and again at week two, four, six, and 90 days post treatment. At each testing point a questionnaire and physical examination were performed without prior documentation present in order to avoid bias. Testing included the Oswetry questionnaire, which was utilized to quantify information related to measurement of symptoms and functional status. Ten categories of questions about everyday activities were asked prior to the first session and again after treatment and 30 days following the last treatment.
Testing also consisted of a modified physical examination, including evaluation of reflexes (normal, sluggish, or absent), gait evaluation, the presence of kyphosis, and a straight leg raising test (radiating pain into the lower back and leg was categorized when raising the leg over 30 degrees or less is considered positive, but if pain remained isolated in the lower back, it was considered negative). Lumbar range of motion was measured with an ergonometer. Limitations ranging from normal to over 15 degrees in flexion and over 10 degrees in rotation and extension were positive findings. The investigator used pinprick and soft touch to determine the presence of gross sensory deficit in the lower extremities.
Of the 229 patients selected, only 10 patients did not complete the treatment protocol. Reasons for noncompletion included transportation issues, family emergencies, scheduling conflicts, lack of motivation, and transient discomfort. The patient protocol provided for 20 treatments of spinal decompression over a 6-week course of therapy. Each session consisted of a 45-minute treatment on the equipment followed by 15 minutes of ice and interferential frequency therapy to consolidate the lumbar paravertebral muscles. The patient regimen included 2 weeks of daily spinal decompression treatment (5 days per week), followed by three sessions per week for 2 weeks, concluding with two sessions per week for the remaining 2 weeks of therapy
On the first day of treatment, the applied pressure was measured as one half of the person’s body weight minus 10 pounds, followed on the second day with one half of the person’s body weight. The pressure placed for the remainder of the 18 sessions was equivalent to one half of the patient’s body weight plus an additional 10 pounds. The angle of treatment was set according to manufacturer’s protocol after identifying a specific lumbar disc correlated with MRI findings. A session would begin with the patient being fitted with a customized lower and upper harness to fit their specific body frame. The patient would step onto a platform located at the base of the equipment, which simultaneously calculated body weight and determined proper treatment pressure. The patient was then lowered into the supine position, where the investigator would align the split of table with the top of the patient’s iliac crest. A pneumatic air pump was used to automatically increase lordosis of the lumbar spine for patient comfort. The patient’s chest harness was attached and tightened to the table. An automatic shoulder support system tightened and affixed the patient’s upper body. A knee pillow was placed to maintain slight flexion of the knees. With use of the previously calculated treatment pressures, spinal decompression was then applied. After treatment, the patient received 15 minutes of interferential frequency (80 to 120 Hz) therapy and cold packs to consolidate paravertebral muscles.
During the initial 2 weeks of treatment, the patients were instructed to wear lumbar support belts and limit activities, and were placed on light duty at work. In addition, they were prescribed a nonsteroidal, to be taken 1 hour before therapy and at bedtime during the first 2 weeks of treatment. After the second week of treatment, medication was decreased and moderate activity was permitted.
Data was collected from 219 patients treated during this clinical study. Study demographics consisted of 79 female and 140 male patients. The patients treated ranged from 24 to 74 years of age (see Table 1). The average weight of the females was 146 pounds and the average weight of the men was 195 pounds. According to the Oswestry Pain Scale, patients reported their symptoms ranging from no pain (0) to severe pain (5).
The patients were further subdivided into six groups:
single lateral herniation 67 cases
single central herniation 22 cases
single lateral herniation
with disc degeneration 32 cases
single central herniation
with disc degeneration. 24 cases
more than 1 herniation
with disc degeneration 17 cases
more than 1 herniation
without disc degeneration 57 cases
According to the self-rated Oswestry Pain Scale, treatment was successful in 86% of the 219 patients included in this study (Table 2, page 39). Treatment success was defined by a reduction in pain to 0 or 1 on the pain scale. The perception of pain was none 0 to occasional 1 without any further need for medication or treatment in 188 patients. These patients reported complete resolution of pain, lumbar range of motion was normalized, and there was recovery of any sensory or motor loss. The remaining 31 patients reported significant pain and disability, despite some improvement in their overall pain and disability score.
Results on self-rated Oswestry Pain Scale after treatment.
In this study, only patients diagnosed with herniated and degenerative discs
with at least a 4-week onset were eligible. Each patient’s diagnosis
was confirmed by MRI findings. All selected patients reported 3 to 5 on the
pain scale with radiating neuritis into the lower extremities. By the second
week of treatment, 77% of patients had a greater than 50% resolution of low
back pain. Subsequent orthopedic examinations demonstrated that an increase
in spinal range of motion directly correlated with an improvement in straight
leg raises and reflex response. Table 2 shows a summary of the subjective
findings obtained during this study by category and total results post treatment.
After 90 days, only five patients (2%) were found to have relapsed from the
initial treatment program.
Percentage of patients that had improved physical exam findings post treatment.
Ninety-two percent of patients with abnormal physical findings improved post-treatment.
Ninety days later only 3% of these patients had abnormal findings. Table
3 summarizes the percentage of patients that showed improvement in physician
examination findings testing both motor and sensory system function after
treatment. Gait improved in 96% of the individuals who started with an abnormal
gait, while 96% of those with sluggish reflexes normalized. Sensory perception
improved in 93% of the patients, motor limitation diminished in 86%, 89%
had a normal straight leg raise test who initially tested abnormal, and 90%
showed improvement in their spinal range of motion.
In conclusion, nonsurgical spinal decompression provides a method for physicians to properly apply and direct the decompressive force necessary to effectively treat discogenic disease. With the biotechnological advances of spinal decompression, symptoms were restored by subjective report in 86% of patients previously thought to be surgical candidates and mechanical function was restored in 92% using objective data. Ninety days after treatment only 2% reported pain and 3% relapsed, by physical examination exhibiting motor limitations and decreased spinal range of motion. Our results indicate that in treating 219 patients with MRI-documented disc herniation and degenerative disc diseases, treatment was successful as defined by: pain reduction; reduction in use of pain medications; normalization of range of motion, reflex, and gait; and recovery of sensory or motor loss. Biotechnological advances of spinal decompression indeed reveal promising results for the future of effective management of patients with disc herniation and degenerative disc diseases. The cost for successful nonsurgical therapy is less than a tenth of that for surgery. Long-term outcome studies are needed to determine if nonsurgical treatment prevents later surgery or merely delays it.
Thomas A. Gionis, MD, JD, MBA, MHA, FICS, FRCS, is chairman of the American Board of Healthcare Law and Medicine, Chicago; a diplomate professor of surgery, American Academy of Neurological and Orthopaedic Surgeons; and a fellow of the International College of Surgeons and the Royal College of Surgeons.
Eric Groteke, DC, CCIC, is a chiropractor and is certified in manipulation under anesthesia. He is also a chiropractic insurance consultant, a certified independent chiropractic examiner, and a certified chiropractic insurance consultant. Groteke maintains chiropractic centers in northeastern Pennsylvania, in Stroudsburg, Scranton, and Wilkes-Barre.
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Westchester Spinal Decompression Center
Call 914-908-5562
1241 Mamaroneck Ave
White Plains,
NY
10605
The sooner you get the treatment you need for sciatica the better. Dr. Jonathan Donath in Westchester, uses non-surgical spinal decompression as a treatment for his patients, which can relieve nerve compression, often associated with sciatica.
NY Rehab, Pain Management & Medical Services, P.C.
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32-44 31st Street
Astoria,
NY
11106
Suffering from painful sciatica? At NYREHAB Pain Management & Medical Services P.C., in Astoria, Long Island City, Queens, NY Dr. Howard Goodman, D.C. specializes in delivering spinal decompression. He utilizes the SpinalAid exclusive core stabilization and bracing procedures to reinforce spinal strength and relieve pain to ensure long-term health and recovery for patients.
Staten Island DRX
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3204 Amboy Rd.
Staten Island,
NY
10306
Have you or a loved one struggle with nagging neck pain? Do you find yourself relying on painkillers just to get a full night of sleep or get through the work day? At Staten Island DRX there's a better way to treat chronic neck pain than drugs or surgery. A little know-technology called spinal disc decompression has helped people all around the world get safe, effective and affordable neck pain relief. Led by Dr. Robert M. Browne DC, Staten Island DRX offers some of the best conservative treatments options on the market today. Don't let neck pain hold you back any longer. Those in the Staten Island, NY area, contact Dr. Robert M. Browne today.
MedWell, L.L.C. Sports Medicine & Physical Therapy
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33 Central Ave
Midland Park,
NJ
07432
Are you fed up with that constant pain in your lower back that just wont go away? Watching your every move because the wrong one will temporarily disable you from engaging in normal activities? Although a herniated or bulging disc may be painful, many people feel that it cannot be helped and just live with it. But you don't need to live with pain, contact MedWell, L.L.C. Sports Medicine and Physical Therapy Center in Midland Park, Bergen County, NJ, and find out how we can help.
Empire Physical Medicine & Pain Management
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551 5th Avenue Ste. 525
New York,
NY
10176
Do you find the most normal activities like walking a challenge because of back pain? Spinal Decompression treatment can help ease that back pain as well as provide preventative care for future spinal injuries. An ExtenTrac Certified Practice near the Upper West Side of Manhattan, NYC is well trained and, close by to Grand Central Terminal, isn't hard to get to.
Detroit Institute for Spinal Care
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5600 W. Maple Road St, A110
West Bloomfield,
MI
48322
If you were unable to get out of bed this morning due to back pain, you are not alone. 6.5 million people on any given day are in the same situation. Dr. Eric Mintz, DC at Detroit Institute for Spinal Care is working to prevent that number from growing. .
Call 888-283-6198
224 Midland Ave.
Saddle Brook,
New Jersey
07663
The pain in your back can be so severe that you can barely move, stand, sit or sleep. The sharp pain may be caused by Spinal Stenosis, a narrowing of the spinal canal often due to aging or genetic factors, but it can be effectively treated with a combination of treatments. Dr. Peter Ferraro, DC gives patients hope to overcome pain and live a more fulfilling life.
Synergy Pain Relief
Call 888-216-3329
2011 S. Washington Street
Naperville,
IL
60565
Is back pain getting you down? Do you feel overtly exhausted or hurt every time you sit or stand, and want individual treatment for back pain? At Syergy Pain Relief Institute in Bolingbrook, Illinois, the family of doctors and pain specialists can grant you relief from pain with Spinal Decompression, today's revolutionary back pain treatment.
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632 Broadway, Ste 303 (btw. Bleecker & Houston)
NYC,
NY
10012
If agonizing back pain is making each day a struggle, then effective treatment is something you owe to yourself. At New York Integrative Medical and Rehab near the B, D, F, V, N, R, W, and 6 train in Downtown NYC, Dr. Steven Shoshany and his team of professionals can deliver quality back pain treatment that will provide you with pain relief as well as a functional lifestyle.
Spinal Relief Center USA
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13325 100th Ave NE Ste B&C
Kirkland,
Washington
98034
In the U.S, there are a number of individuals who live day-to-day with continuous low back pain. For some, this condition negatively impacts their performance in many aspects of their life. If you also suffer from this problem, you should know that living with it on a regular basis isn't your only option. Believe it or not, you can successfully treat your condition by receiving the proper care from a low back pain doctor who is qualified to eliminate your pain. At Spine Relief Center, USA in Seattle, Dr. Jeremy Meadows, DC is just the right candidate to deliver treatment that works according to your individual needs.
Back & Neck Pain Center of Greenwich, P.C.
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Greenwich,
CT
06830
Is sciatica bogging you down? Seek pain relief with Dr. Adrian Marcus at Greenwich Pain Relief in Fairfield County. This is a place where they know pain and can offer you non-surgical, non-invasive treatment options. Dr. Marcus is a Diplomate of the Academy of Medical Acupuncture.
Keller Chiropractic
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372 Kingston Ave.
Crown Heights,
NY
11213
Are you in need of back pain treatment? At Keller Chiropractic in Crown Heights, Brooklyn, NY, Dr. Melinda Keller, D.C. provides treatment for a variety of conditions causing back pain. Back pain usually originates from muscles, nerves, bones, joints or other structures in the spine. The pain may be felt in the neck, in the upper back, or in the low back, and may include symptoms other than pain, such as weakness, numbness or tingling.
Ann Arbor Institute for Spinal Care
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5740 Plymouth Rd.
Ann Arbor,
MI
48105
Suffering from back pain so intense that you can't take it anymore is an ordeal. If this sounds like your situation, you shouldn't have to live with back pain any longer - the good news is that it can be treated properly, effectively, and safely. If you need to find a chiropractor in Canton, Michigan for intense back pain, make an appointment with Dr. Jon Grenillo, DC, of the Ann Arbor Institute for Spinal Care. Dr. Grenillo is a Michigan chiropractor who works with a medically-educated staff. Using high-tech technology, it is Dr. Grenillo's goal to find the source of your pain and help you without surgery.
New York Integrative Medical and Rehab
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632 Broadway, Ste 303 (btw. Bleecker & Houston)
New York City,
NY
10012
Spinal decompression offers real hope to long time back pain sufferers. New York Integrative Medical and Rehab in New York near the B, D, F, V, N, R, W, and 6 train offers a multi-disciplinary approach to advanced spinal correction with a variety of non-surgical techniques as well as exercises and lifestyle advice. As the founder and director of New York Integrative Medical and Rehab, Dr. Steven Shoshany D.C, C.C.E.P. has a diversified educational background with specialized knowledge in Spinal Decompression, Chiropractic, and Sports Injury Management. A treatment regimen with spinal decompression can put an end to your back and neck pain.
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Spinal Decompression is a revolutionary technology that is changing the way people treat their back and neck pain. In the past those with debilitating back, neck or spine conditions had to rely on drugs or surgery for treatment. Spinal Disc Decompression is a non-invasive, non-surgical treatment technology that has revolutionized pain relief. In the hands of the right doctor it can treat many pain conditions including sciatica herniated disc, bulging discs, spinal stenosis, degenerative disc disease, fibromyalgia and more.
North East Spine & Rehab
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363 Route 111, St 107
Smithtown,
NY
11787
If you are suffering from Cervical Pain in the Smithtown, Long Island area, then Dr. Daniel Crews, DC and Dr. Kathryn Crews, DC, have a highly effective spinal positioning therapy. It is called the M3D® Therapeutic Protocol and it is a revolutionary technique that will finally give you the relief you've been searching for.
Peterson Clinic of Chiropractic
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6951 E. 71st Street
Tulsa,
OK
74133
Pain on the outside of the elbow, pain when using the arm, pain when lifting anything - even the lightest of objects - these are all signs of tennis elbow. Despite the name, this condition can happen to anyone, not only tennis players. Anyone who uses his or her arm in a repetitive motion, day after day, can develop that severe, burning pain. Prescription drugs or surgery, are an option, but they don't always help and you put yourself at risk for side effects. Dr. Michael Peterson of the Peterson Clinic of Chiropractic in Tulsa, Oklahoma, treats patients with tennis elbow and elbow pain with a combination of natural, non-invasive therapies.
Valley Spinal Decompression Center
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5363 Balboa Blvd. Suite 430
Encino,
CA
91316
Are you suffering from lumbar or lower back pain and want to find an effective and non-surgical way to treat it? Then you should consider receiving treatment from Dr. Bruce Shannahoff, DC and Valley Spinal Decompression Center at the West Valley Medical Center near Los Angeles, CA right away. The staff of medical professionals there is waiting to deliver treatment and valuable guidance that will considerably reduce your suffering and help you sustain a healthy and active lifestyle.
Spinal Correction Center of Richmond
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8536 Patterson Ave.
Richmond,
Virginia
23229
If you are one of the many people struggling with back pain, you are not alone. Back pain is one of the most common afflictions affecting adults today. The Spinal Correction Center of Richmond is committed to providing you with the highest quality chiropractic care, spinal decompression, and postural correction. With years of experience helping patients, Dr. Michael Mulvaney, DC, not only gives you the best in standard chiropractic care, he also specializes in Lumbar (Spinal) Decompression. If pain is keeping you from doing everyday activities, there is now a safe, non-surgical way to treat it.
Waterfront Institute for Spine and Joint Rehabilitation
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115 River Rd, Bld 10
Edgewater,
NJ
07020
Do you have chronic knee pain? Have you considered knee/joint replacement? Surgery can be risky and take months and even years to fully recover from. Waterfront Institute in Bergen County, New Jersey utilizes synvisc/hyalgan to treat knee pain. If you are in pain call today.