Chronic Low Back Pain
Conditions
Brief summary
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
Interventions
OTHERMSDR
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.
Sponsors
MedAppraise, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To document the musculoskeletal profile of patients with low back pain | 1 year |
Secondary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactEric K Groteke, DC
Backup ContactDamon J Stafford, DC
Outcome results
None listed