Spinal Decompression In New York City, DRX 9000
www.drshoshany.com
Spinal decompression-What should patients expect with Spinal decompression treatment
I have been using spinal decompression in my NYC Chiropractic Clinic for over 6 years and have treated several hundred patients with spinal decompression. I also wanted to share patient outcomes(names withheld for patient privacy.)
Will every patient experience a positive outcome with spinal decompression and the DRX 9000?
Spinal decompression is a great tool that I utilize in my treatment protocol for patients that have Sciatica, Herniated discs, and spinal stenosis. It is by no means a guaranteed patient outcome. Studies conducted by the Mayo Clinic and a John Hopkins professor report a 75%-88% positive outcome.Visit my website to see those studies at www.drshoshany.com
There is always going to be a group of patients that meet all the criteria and seem to be perfect for treatment and they do not respond. In my years of practice and utilizing spinal decompression I have also seen patients that respond amazingly well to the treatment.
I can think of one recent case:
She came in severely antalgic (lean to one side) on disability from work and having to have her sister bathe her in the tub because she couldn't stand for more than 5 minutes without shooting pain down her leg. She brought in her recent MRI, a nerve test that confirmed nerve involvement. She already had three epidural injections,(they will not do more after 3 usually) and was told she needed a microdisectomy.
She is only 39!Surgery was not an option.
I accepted her case and made it clear that this is not a guaranteed success and she told me the surgeon said the same thing.It was both a financial commitment and time commitment. She improved so much that now she is back to work, no longer taking bathes with her sister and recently joined a kickboxing class. She was diligent with her treatment protocol that involved spinal decompression, SOT blocking,Physical therapy on the SpineForce, Custom made corrective orthotics and home exercise.
I really feel that a patient must involve themselves after the treatment is complete and become aware of the core muscles(not just the abdominal's.) This refers to the muscles that run up the back and strech down the butt and front and inner thighs.This group of muscles is where much of the body's strength comes from,you use it to kick a ball, lift a heavy box, and even stand up straight.
She is the perfect example of a positve outcome. This treatmet was non-invasive and produced excellent pain relief when nothing else was working.
When should I know treatment on spinal decompression is working?
The treatment protocol that has been shown to be the most effective calls for approximatly 20 visits over a 6 week period.
I have seen patients respond by the fifth visit and I have also had patients that completed treatment and really didn't feel results until weeks after the decompression sessions have stopped.
This reminds me of the first patient that I had that started on the DRX 9000.
He is a well nourished male with foot drop on his right foot and calf pain.
He had a MRI that confirmed presence of a disc herniation on his L5- S1 disc putting pressure on his nerve root and a NCV confirming nerve involvement.
He was diligent with his appointments and showed little progress throughout treatment. I was confused as to why he was not responding but we both where determined to make this treatment work.
He finished all his vists and still not much improvement expect a "looser back" he still had a foot drop and calf pain.Three weeks later I get a call and he was elated that all his symptoms have disappeared several weeks after we completed treatment.
I was relieved that he was better, and ordered a post MRI but instructed him to wait at least 3 months( blood supply to the disc is slow) and it showed a significant decrease in disc herniation size and a increase in canal height and increase in disc height! The point I am trying to make is that some patients respond quickly, some don't respond until after treatment is complete and some do not respond at all.
Another recent example is a young girl that tried Physical therapy, Epidurals, Chiropractic, Acupuncture and Vicodin, Cortisone.. basically everything expect surgery.
This was her last resort,
Today was her 20 visit, She went from being a overly medicated unhappy 34 year old women to a functional person that has returned to her normal activities without pain.
www.drshoshany.com
I wanted to post a clinical study below that was done on DRX 9000
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain
Further study details as provided by NEMA Research, Inc.:
Study Start Date: December 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Male or female, greater than 18 years of age
Able to understand possible risks and benefits and provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
LBP with an intensity level of greater than 4 on an eleven point numerical pain rating scale (VRS) of 0-10 (with 0 - no pain and 10 - worst possible pain)
Completed the necessary diagnostic and medical history evaluations as described in the protocol to confirm the patient's diagnosis and eligibility for the study and DRX9000 treatment protocol.
Willing and able to complete a six week 20 session of DRX9000 outpatient treatments and a minimum of 6 months follow-up
Exclusion Criteria:
Pregnancy
Evidence of neurological motor deficits on clinical examination
Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
Evidence of severe central stenosis with neurological deficits or nerve root entrapment
Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury
Previous spine fusion surgery, insertion of hardware or artificial disc
Hemiplegia or paraplegia
History of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm
Unwillingness to postpone other types of therapy for LBP during the 6 week treatment sessions
Known alcohol abuse or drug abuse
Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)
Body weight greater than 300 pounds (136 kg)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414596
Locations
United States, California
Vibrance Medical Group
Beverly Hills, California, United States, 90212
United States, Florida
Active Health and Wellness Center
Tampa, Florida, United States, 33614
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108
Sponsors and Collaborators
NEMA Research, Inc.
Investigators
Principal Investigator: John Leslie, MD Mayo Clinic Arizona
Study Director: Charlotte Richmond, PhD NEMA Research, Inc.
Study Chair: Joseph V Pergolizzi, MD Naples Anesthesia and Pain Associates
More Information
click here for more information about the DRX9000
Nema Research website
Study ID Numbers: P-AXW01
First Received: December 19, 2006
Last Updated: February 14, 2008
ClinicalTrials.gov Identifier: NCT00414596
Health Authority: United States: Institutional Review Board
Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain
Additional relevant MeSH terms:
Nervous System Diseases
ClinicalTrials.gov processed this record on December 02, 2008
Another study underway
To administer the MSDR® (Musculoskeletal Disorder Reporting) instrument to document the musculoskeletal profile of patients with chronic low back pain, a prospective, non-randomized, multicenter treatment trial
Condition Intervention
Chronic Low Back Pain
Other: MSDR
MedlinePlus related topics: Back Pain
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening, Randomized, Open Label, Parallel Assignment
Official Title: This is a Study is for the Purpose of Quantifying Function of the Back and Lower Extremities, and to Assess the Inter-Regional Biomechanical Relationships of the Neck, Upper Extremities, Back, and Lower Extremities in Patients Suffering From Chronic Low Back Pain.
Further study details as provided by MedAppraise, Inc.:
Primary Outcome Measures:
To document the musculoskeletal profile of patients with low back pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
To determine if a particular lower back diagnosis or MSDR® score can predict which patients will respond particularly well to the DRX9000™ treatment protocol and spinal manipulative therapy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
Other: MSDR
The MSDR® questionnaire establishes an individual's musculoskeletal functional status using information gathered from 1) a questionnaire the patient fills out regarding medical history, chronic medical conditions, and health risk factors; 2) anatomic pain survey completed by the patient; and 3) evaluation by a trained researcher of various patient biometric parameters related to range of motion. Stratifying an individual into a risk category with this evidence-based assessment tool then permits an assessment of which patients respond long term to therapy.
MSDR® demonstrates the ability to benchmark specific musculoskeletal findings (both clinical and sub-clinical) to ICD-9 Diagnoses supported by diagnostic, radiographic and/or MRI findings where clinically indicated.
Eligibility
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Must have Informed Consent Signed
Lumbar Disc Herniations under 5mm without Sequestered Fragments
Lumbar Disc Bulging
Lumbar Degenerative Disc Disease (mild and moderate severity)
Non-pregnant Females and Males suffering from Chronic Low Back Pain from 18 to 65 years of age
Segmental Dysfunction Secondary to Dyskinesia
Unresolved Nerve Entrapment Syndrome
Patients must be able to comply with study protocol
Joint Fixation Syndrome
Premenopausal Female Patients, excluding patients who have undergone a hysterectomy, oophorectomy, or tubal ligation, must have one of the following methods of contraception and must have a negative serum or urine b-HCG pregnancy test performed within 48 hours before initiating protocol specified treatment.
Exclusion Criteria:
Contraindications to Spinal Manipulative Therapy
Lumbar Canal Stenosis resulting in significant neurological comprimise
Any Spinal Cord Compression resulting in significant neurological comprimise
Cauda Equina Syndrome
Infection
Osteomyelitis
->65 years of age
History of Back or Neck Surgery
Acute Arthritis
Signs or Symptoms of Arterial Aneurysm
History of Active Cancer with Bone Metastasis
Widespread Staphyloccal and/or Strepococcal Infection
Acute Gout
Serious unstable medical illness such as cardiovascular, renal, respiratory, endocrine, gastrointestinal, or psychiatric.
Unstable Spondylosis, Spondylolisthesis, or Spondylolysis
Prior adverse experience with Spinal Manipulation Therapy
Uncontrolled Diabetic Neuropathy
Gonorreal Spinal Arthritis
Tuberculosis to the Bone
Maligancy with Metatasis to Bone
Excessive Spinal Osteoporosis
Osteomalacia
Ankylosis
Syphlitic Articular or Peri-Articular Lesions
Active Low Back Injury Resulting from a Motor Vehicle Accident or Work Related Injury
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732394
Contacts
Contact: Eric K Groteke, DC 727-797-0500 egroteke@medappraise.com
Contact: Damon J Stafford, DC 727-797-0500 drdamon7@aol.com
Locations
United States, Florida
Back2Life of Florida, Inc. Recruiting
Clearwater, Florida, United States, 33761
Contact: Tammy Cravotta 727-797-0500
Contact: Matt Erickson, DC 727-797-0500
Sponsors and Collaborators
MedAppraise, Inc.
Investigators
Study Chair: Eric K Groteke, DC MedAppraise, Inc.
Principal Investigator: Luis Crespo, MD Crespo and Associates
Study Director: Mark Scinico, MD Concentra
Principal Investigator: Damon J Stafford, DC Back2Life of Florida, Inc.
More Information
MSDR
Responsible Party: Back2Life of Florida, Inc. ( Damon J. Stafford, D.C. )
Study ID Numbers: TCT06-002
First Received: August 8, 2008
Last Updated: August 8, 2008
ClinicalTrials.gov Identifier: NCT00732394
Health Authority: United States: Institutional Review Board
Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain
Spinal decompression-What should patients expect with Spinal decompression treatment
I have been using spinal decompression in my NYC Chiropractic Clinic for over 6 years and have treated several hundred patients with spinal decompression. I also wanted to share patient outcomes(names withheld for patient privacy.)
Will every patient experience a positive outcome with spinal decompression and the DRX 9000?
Spinal decompression is a great tool that I utilize in my treatment protocol for patients that have Sciatica, Herniated discs, and spinal stenosis. It is by no means a guaranteed patient outcome. Studies conducted by the Mayo Clinic and a John Hopkins professor report a 75%-88% positive outcome.Visit my website to see those studies at www.drshoshany.com
There is always going to be a group of patients that meet all the criteria and seem to be perfect for treatment and they do not respond. In my years of practice and utilizing spinal decompression I have also seen patients that respond amazingly well to the treatment.
I can think of one recent case:
She came in severely antalgic (lean to one side) on disability from work and having to have her sister bathe her in the tub because she couldn't stand for more than 5 minutes without shooting pain down her leg. She brought in her recent MRI, a nerve test that confirmed nerve involvement. She already had three epidural injections,(they will not do more after 3 usually) and was told she needed a microdisectomy.
She is only 39!Surgery was not an option.
I accepted her case and made it clear that this is not a guaranteed success and she told me the surgeon said the same thing.It was both a financial commitment and time commitment. She improved so much that now she is back to work, no longer taking bathes with her sister and recently joined a kickboxing class. She was diligent with her treatment protocol that involved spinal decompression, SOT blocking,Physical therapy on the SpineForce, Custom made corrective orthotics and home exercise.
I really feel that a patient must involve themselves after the treatment is complete and become aware of the core muscles(not just the abdominal's.) This refers to the muscles that run up the back and strech down the butt and front and inner thighs.This group of muscles is where much of the body's strength comes from,you use it to kick a ball, lift a heavy box, and even stand up straight.
She is the perfect example of a positve outcome. This treatmet was non-invasive and produced excellent pain relief when nothing else was working.
When should I know treatment on spinal decompression is working?
The treatment protocol that has been shown to be the most effective calls for approximatly 20 visits over a 6 week period.
I have seen patients respond by the fifth visit and I have also had patients that completed treatment and really didn't feel results until weeks after the decompression sessions have stopped.
This reminds me of the first patient that I had that started on the DRX 9000.
He is a well nourished male with foot drop on his right foot and calf pain.
He had a MRI that confirmed presence of a disc herniation on his L5- S1 disc putting pressure on his nerve root and a NCV confirming nerve involvement.
He was diligent with his appointments and showed little progress throughout treatment. I was confused as to why he was not responding but we both where determined to make this treatment work.
He finished all his vists and still not much improvement expect a "looser back" he still had a foot drop and calf pain.Three weeks later I get a call and he was elated that all his symptoms have disappeared several weeks after we completed treatment.
I was relieved that he was better, and ordered a post MRI but instructed him to wait at least 3 months( blood supply to the disc is slow) and it showed a significant decrease in disc herniation size and a increase in canal height and increase in disc height! The point I am trying to make is that some patients respond quickly, some don't respond until after treatment is complete and some do not respond at all.
Another recent example is a young girl that tried Physical therapy, Epidurals, Chiropractic, Acupuncture and Vicodin, Cortisone.. basically everything expect surgery.
This was her last resort,
Today was her 20 visit, She went from being a overly medicated unhappy 34 year old women to a functional person that has returned to her normal activities without pain.
www.drshoshany.com
I wanted to post a clinical study below that was done on DRX 9000
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Pilot Study to Evaluate The Effectiveness And Safety Of Axiom Worldwide Drx9000™ Spinal Decompression System For Treatment of Low Back Pain
Further study details as provided by NEMA Research, Inc.:
Study Start Date: December 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Male or female, greater than 18 years of age
Able to understand possible risks and benefits and provide written informed consent (ICF) to the IRB approved clinical multimodal protocol
LBP with an intensity level of greater than 4 on an eleven point numerical pain rating scale (VRS) of 0-10 (with 0 - no pain and 10 - worst possible pain)
Completed the necessary diagnostic and medical history evaluations as described in the protocol to confirm the patient's diagnosis and eligibility for the study and DRX9000 treatment protocol.
Willing and able to complete a six week 20 session of DRX9000 outpatient treatments and a minimum of 6 months follow-up
Exclusion Criteria:
Pregnancy
Evidence of neurological motor deficits on clinical examination
Evidence of spinal cord compression, metastatic cancer, tumor, hematoma, infection or compression fracture
Evidence of severe central stenosis with neurological deficits or nerve root entrapment
Litigation for health-related claim (in process or pending), Worker's Compensation, or Personal Injury
Previous spine fusion surgery, insertion of hardware or artificial disc
Hemiplegia or paraplegia
History of severe cardiovascular or metabolic disease, or abdominal aortic aneurysm
Unwillingness to postpone other types of therapy for LBP during the 6 week treatment sessions
Known alcohol abuse or drug abuse
Height less than 4 feet 10 inches (147 cm) or greater than 6 feet 8 inches (203 cm)
Body weight greater than 300 pounds (136 kg)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414596
Locations
United States, California
Vibrance Medical Group
Beverly Hills, California, United States, 90212
United States, Florida
Active Health and Wellness Center
Tampa, Florida, United States, 33614
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108
Sponsors and Collaborators
NEMA Research, Inc.
Investigators
Principal Investigator: John Leslie, MD Mayo Clinic Arizona
Study Director: Charlotte Richmond, PhD NEMA Research, Inc.
Study Chair: Joseph V Pergolizzi, MD Naples Anesthesia and Pain Associates
More Information
click here for more information about the DRX9000
Nema Research website
Study ID Numbers: P-AXW01
First Received: December 19, 2006
Last Updated: February 14, 2008
ClinicalTrials.gov Identifier: NCT00414596
Health Authority: United States: Institutional Review Board
Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain
Additional relevant MeSH terms:
Nervous System Diseases
ClinicalTrials.gov processed this record on December 02, 2008
Another study underway
To administer the MSDR® (Musculoskeletal Disorder Reporting) instrument to document the musculoskeletal profile of patients with chronic low back pain, a prospective, non-randomized, multicenter treatment trial
Condition Intervention
Chronic Low Back Pain
Other: MSDR
MedlinePlus related topics: Back Pain
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening, Randomized, Open Label, Parallel Assignment
Official Title: This is a Study is for the Purpose of Quantifying Function of the Back and Lower Extremities, and to Assess the Inter-Regional Biomechanical Relationships of the Neck, Upper Extremities, Back, and Lower Extremities in Patients Suffering From Chronic Low Back Pain.
Further study details as provided by MedAppraise, Inc.:
Primary Outcome Measures:
To document the musculoskeletal profile of patients with low back pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
To determine if a particular lower back diagnosis or MSDR® score can predict which patients will respond particularly well to the DRX9000™ treatment protocol and spinal manipulative therapy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
Other: MSDR
The MSDR® questionnaire establishes an individual's musculoskeletal functional status using information gathered from 1) a questionnaire the patient fills out regarding medical history, chronic medical conditions, and health risk factors; 2) anatomic pain survey completed by the patient; and 3) evaluation by a trained researcher of various patient biometric parameters related to range of motion. Stratifying an individual into a risk category with this evidence-based assessment tool then permits an assessment of which patients respond long term to therapy.
MSDR® demonstrates the ability to benchmark specific musculoskeletal findings (both clinical and sub-clinical) to ICD-9 Diagnoses supported by diagnostic, radiographic and/or MRI findings where clinically indicated.
Eligibility
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Must have Informed Consent Signed
Lumbar Disc Herniations under 5mm without Sequestered Fragments
Lumbar Disc Bulging
Lumbar Degenerative Disc Disease (mild and moderate severity)
Non-pregnant Females and Males suffering from Chronic Low Back Pain from 18 to 65 years of age
Segmental Dysfunction Secondary to Dyskinesia
Unresolved Nerve Entrapment Syndrome
Patients must be able to comply with study protocol
Joint Fixation Syndrome
Premenopausal Female Patients, excluding patients who have undergone a hysterectomy, oophorectomy, or tubal ligation, must have one of the following methods of contraception and must have a negative serum or urine b-HCG pregnancy test performed within 48 hours before initiating protocol specified treatment.
Exclusion Criteria:
Contraindications to Spinal Manipulative Therapy
Lumbar Canal Stenosis resulting in significant neurological comprimise
Any Spinal Cord Compression resulting in significant neurological comprimise
Cauda Equina Syndrome
Infection
Osteomyelitis
->65 years of age
History of Back or Neck Surgery
Acute Arthritis
Signs or Symptoms of Arterial Aneurysm
History of Active Cancer with Bone Metastasis
Widespread Staphyloccal and/or Strepococcal Infection
Acute Gout
Serious unstable medical illness such as cardiovascular, renal, respiratory, endocrine, gastrointestinal, or psychiatric.
Unstable Spondylosis, Spondylolisthesis, or Spondylolysis
Prior adverse experience with Spinal Manipulation Therapy
Uncontrolled Diabetic Neuropathy
Gonorreal Spinal Arthritis
Tuberculosis to the Bone
Maligancy with Metatasis to Bone
Excessive Spinal Osteoporosis
Osteomalacia
Ankylosis
Syphlitic Articular or Peri-Articular Lesions
Active Low Back Injury Resulting from a Motor Vehicle Accident or Work Related Injury
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732394
Contacts
Contact: Eric K Groteke, DC 727-797-0500 egroteke@medappraise.com
Contact: Damon J Stafford, DC 727-797-0500 drdamon7@aol.com
Locations
United States, Florida
Back2Life of Florida, Inc. Recruiting
Clearwater, Florida, United States, 33761
Contact: Tammy Cravotta 727-797-0500
Contact: Matt Erickson, DC 727-797-0500
Sponsors and Collaborators
MedAppraise, Inc.
Investigators
Study Chair: Eric K Groteke, DC MedAppraise, Inc.
Principal Investigator: Luis Crespo, MD Crespo and Associates
Study Director: Mark Scinico, MD Concentra
Principal Investigator: Damon J Stafford, DC Back2Life of Florida, Inc.
More Information
MSDR
Responsible Party: Back2Life of Florida, Inc. ( Damon J. Stafford, D.C. )
Study ID Numbers: TCT06-002
First Received: August 8, 2008
Last Updated: August 8, 2008
ClinicalTrials.gov Identifier: NCT00732394
Health Authority: United States: Institutional Review Board
Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain
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