Low Back Pain-
You're Not Alone

Low back pain affects 540 million people worldwide and is the leading cause of disability. An estimated 80% of the adults in the U.S. and 50% in Europe suffer intractable back pain at some point in their life and most find no relief.

Worldwide, disability from chronic back pain has risen more than 50 percent since 1990. Low back pain (LBP) is a challenging condition to treat and one of the most common health problems adults today. Back pain is the leading cause of visits to orthopedic surgeons and the second leading cause of visits to general practitioners.

Common Situation

Disc degeneration is happening to all of us; for most of us it causes pain, for some - chronic pain!

  • Annulus tissue (disc) becomes delaminated, fissured, or micro-damaged; causing pain!

  • Spinal joint becomes unstable; causing pain!

  • Disc bulges against nerves; causing pain!

Risk Factors Related to Low Back Pain (US)

Anyone can have back pain, but some things that increase your risk are:

  • Age. You are most likely to have your first episode of back pain when you are in your late 20s to early 30s.

  • Poor Physical Fitness. Back pain is more common in people who are not fit.

  • Being Overweight (Obesity). Too much weight can stress the back and cause pain.

  • Heredity/Genetic. Studies have shown that there is a link between heredity and back pain.

  • Your Job. If you lift, push, or pull, while twisting your spine, you may get back pain. If you work at a desk all day, you may also get back pain.

  • Smoking. Your body may not be able to get enough nutrients to the discs in your back if you smoke. Smoker’s cough may also cause back pain. People who smoke are slow to heal, so the limited healing capacity of these tissues is further inhibited.

 

Risk Factors Related to Low Back Pain (Outside the US)

While many of the same risk factors that affect the US adult also affect adults in the rest-of-the-world, there are a few differences.

  • Obesity. Although, this is less of a factor outside the US.

  • Soft Tissue Damage. Causes include twisting too hard, bending over for too long, lifting something overly heavy and sleeping in an odd position. More common outside the US.

  • Dietary Issues. A diet low in natural calcium, magnesium, potassium and other essential nutrients can lead to poor development of the spine.

Low Back Pain: Now What?

Initially, Intralink-Spine, Inc. (ILS) suggests that you try various types of medications (avoiding opioids) and exercise to relieve your low back pain before undergoing the GENT treatment. While ILS strongly suggests you consult your Primary Care Provider (PCP) or Pain Management Specialist (PMS), some early non-surgical alternatives to consider are:

 

  • Hot/Cold Packs: Hot or cold packs can soothe sore, stiff backs. Heat reduces muscle spasms and pain. Cold helps reduce swelling and numbs deep pain. Using hot or cold packs may relieve pain, but this treatment does not fix the cause of chronic low back pain.

  • Exercise: Proper exercise can help ease chronic pain, but should not be used for acute back pain. A licensed doctor or physical therapist is needed to tell you the best types of exercise to do.

  • Medications: Consult your PCP or PMS before using any medications.

  • Physical Therapy: Many, usually at the physician’s request, will seek relief via the use of physical therapy.

 

Surgical options:

  • Epidural Steroid Injections (ESI): Your PCP or PMS may suggest steroid or numbing shots (epidural steroid injections-ESI) to lessen back pain. In an ESI, medication is injected into the space around the lumbar nerve roots. This area is called the epidural space. Some doctors inject only a steroid. Most doctors, however, combine a steroid with a long-lasting numbing medication. Generally, an ESI is given only when other treatments aren't working. But, ESI’s are not always successful in relieving pain. If they do work, they only provide temporary relief.

  • Neuromodulation: Uses electrical signals to block the pain; however, like ESI’s it does not fix the cause. And, most implanted devices require frequent or daily recharging to maintain their function.

  • Fusion:  A spinal fusion surgery is designed to “stop the motion” at a painful vertebral segment, which in turn should decrease pain generated from the joint. A spine fusion surgery involves using bone graft to cause two vertebral bodies to grow together into one long bone. Spinal fusion is major surgery, usually lasting several hours.

 

Note: ILS does not recommend, endorse, or in any way provide advice toward a patient treatment pathway. Please consult your PCP or a trained/licensed professional before undertaking any treatment for low back pain.

 

Time To Consider A New Option For The Treatment Of Low Back Pain: Réjuve

Consult your PCP or PMS to ask about the GENT treatment for low back pain. GENT is not right for everyone, so make sure to consult with your PCP or PMS to ensure GENT is the right low back pain treatment for you. If he/she is unfamiliar with the new GENT treatment, then ask him/her to contact ILS via the website (www.IntralinkSpine.com) for information and availability of GENT.

 

Note: The GENT treatment, while approved for use in the EU, has not been approved by the FDA for use in the US or by Health Canada. Use outside the EU is prohibited.

GENT (GENipin nano-Tethers)

 

 

Single, micro-invasive treatment that has the potential to improve joint stability and motion (over fusion), while providing long-term pain relief (unlike steroid injections).

GENT reduces pain by:

  • Strengthening annulus against tearing and delamination

  • Increasing joint stability

  • Reducing disc bulge

 

GENT provides a network of load-supporting polymers, or nano-tethers throughout the degraded tissue matrix which make the tissue mechanically stronger and the spinal joint more stable.

 

GENT has shown to offer:

  • Long-term results*

  • Rapid results*

  • Improved movement*

  • Reduction in pain*

 

*More clinical data needed to confirm effects.

 

GENT: What to Expect

GENT is an injectable medical device intended to treat intervertebral disc degeneration and associated low back pain.  The novel product is composed of a self-polymerizing and self-attaching monomer that is injected as a liquid in a buffered solution into the spinal disc tissue to form tethering polymers that securely bond to the the surface of collagen fibrils throughout the outer region of the disc. By adding these tethering polymers to the tissue matrix, GENT mechanically stabilizes the spinal joint and strengthens the disc tissue to counteract the effects of degenerative disc disease, thereby potentially reducing low back pain.  

 

You should notice an improvement in your low back area within days of the treatment.

 

Consult your PCP or PMS regarding follow up visits and consultations. Ask questions of your PCP or PMS about anything that you don’t understand or want to know more about.

 

Ready to Stabilize and Strengthen Your Back And Enjoy A Better Life…

Contact your Primary Care Provider or Pain Management Specialist to ask about the GENT medical device treatment for low back pain.

 

Note: The GENT treatment, while approved for use in the EU, has not been approved by the FDA for use in the US or by Health Canada. Use outside the EU is prohibited.

© 2020 by Intralink-Spine Inc. 

Attention: The GENTIS medical device is not available for sale in the US, Canada, or EU. Clinical studies are being conducted In Australia.