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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSDR | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To document the musculoskeletal profile of patients with low back pain | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric K Groteke, DC | Contact | 727-797-0500 | egroteke@medappraise.com | |
| Damon J Stafford, DC | Contact | 727-797-0500 | drdamon7@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Eric K Groteke, DC | MedAppraise, Inc. | Study Chair |
| Luis Crespo, MD | Crespo and Associates | Principal Investigator |
| Mark Scinico, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Back2Life of Florida, Inc. | Recruiting | Clearwater | Florida | 33761 | United States |
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| Concentra |
| Study Director |
| Damon J Stafford, DC | Back2Life of Florida, Inc. | Principal Investigator |