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Lower back pain research at Otrimed Clinical Research Center

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LOW BACK PAIN
Degenerative Disc Disease and Low back pain:

Degenerative disc disease is the leading cause of chronic Low Back Pain. The ageing process, repetitive minor trauma or major trauma may lead to internal disc disruption and this, in turn, initiates the process of degenerative disc disease. Internal disc disruption or fissure is characterized by degradation of the nuclear matrix and the development of fissure in the disc1. Prevalence of chronic low back pain is 8.1% (according to the 2008 survey).


How is it caused?

Initially the fissure is radial and then it may extend circumferentially in the annulus. Grade III is when the fissure or tear extends for 2/3rd of the annulus (outer third layer of the disc). Grade III tear causes most of the pain. Normally, Grade I, II tear is not associated with pain. Stress profilometry is a study in which a probe is used to measure stress across the disc. In a normal disc, stresses across are uniform. However, in painful degenerative discs with tear, the stress is reduced in the center of the disc, but it is significantly increased in the posterior portion of the disc leading to tear or fissure50. The increased pressure in the posterior disc causes protrusion and intradiscal tear. Protrusion causes mechanical pain and tear causes chemical sensitivity (chemical nociception) 52by releasing chemicals (cytokines), which cause immense inflammation leading to muscle spasm and pain.

Trauma (major or repetitive minor) leads to fracture of Endplates. This also triggers chemical process in the nucleus leading to loss of water, reduction of nuclear pressure, increasing pressure in the posterior of the disc causing pain. These changes lead to cell death of the cartilage.


Normal Anatomy of disc:

Normal Anatomy of Disc
 Anatomy of Disc


Stages of Disc Degeneration leading to disc herniation:

Current treatment options of painful degenerative disc disease are:

  1. Anti-inflammatory medicine
  2. Muscle Relaxants
  3. Antiseizure medicine
  4. Opioid Medicine
  5. Physical Therapy
  6. Chiropractic treatment
  7. Yoga
  8. TENS unit
  9. Spine Injections, such as Epidural steroid injections, Facet joint block
  10. Spinal Cord Stimulation, Morphine pump
  11. Surgery (discectomy, instrumented fusion, laser assisted surgery etc.)

Significant number of patient continues to suffer from back pain despite all these intervention. Chronic use of anti-inflammatory medication results in high blood pressure, kidney failure, GERD etc. Opioids are inherently risky because of its addiction causing property. Surgery has a high failure rate.
Consequently a lot of patients seek for alternative and at times unproven treatment for seeking relief from pain.
At Otrimed Clinical research, we are conducting two ground breaking research for treating low back pain.


1. The CASCADE (Low back pain from degenerative disc disease) study is looking at a potential new treatment (an investigational product) for people with degenerative disc disease. The investigational product is made from certain type of adult stem cell. Stem cells are immature cells produced by the human body that have the ability to develop into many different types of cells. The stem cells that are looked at in this study are called mesenchymal precursor cells. The cells being used in the study have been carefully collected from bone marrow samples from healthy human adult donors and grown in a laboratory under strict condition. Participants will receive a single injection of investigational product. However, since this is a double blind study, neither participant nor the physician who follows up the patient will know exactly what was administered. There are 2 in 3 chances of receiving the investigational product. The injection will be assigned randomly. Everyone who participates in the study will receive either stem cells (investigational product), an investigational product combined with Hyaluronic acid, or a saline solution, which look like an investigational product. There are 2 in 3 chances of receiving the investigational product and 1 in 3 chances of receiving saline.


2. Chronic Low back pain Study: Since majority of the low back pain cannot be attributed to single cause they are often called nonspecific back pain. The purpose of this research is to compare the effects of the investigational drug Tanezumab* with another drug called tramadol and a placebo to find out which is better for treating chronic low back pain. Tramadol is a drug that is approved by the USA FDA to treat moderate to severe pain in adult and children over 12 years. Tanezumab* is an investigational drug. An investigational drug is one that is not approved for sale in this country by the US FDA. A placebo looks like the study drug but does not contain any drug. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. Tanezumab* is a humanized monoclonal antibody that selectively targets nerve growth factor (NGF), a regulator of pain processing and sensitivity. NGF levels increase as a result of injury or inflammation and in chronic pain states. Tanezumab* selectively binds to NGF, thereby inhibiting this protein from activating pain-signaling neurons

* http://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_lilly_preparing_to_resume_phase_3_chronic_pain_program_for_tanezumab


CALL US TODAY!

SEE IF YOU QUALIFY FOR AN INVESTIGATIONAL RESEARCH STUDY!
To speak with an experience coordinator or nurse regarding our research studies or for an Emergency

Please call the Main Number at: 859-757-1359

Our hours are flexible and convenient, and someone will call you back as soon as possible.
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OTRIMED CLINICAL RESEARCH CENTER
162 Barnwood Drive, Edgewood, KY 41017
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