A Comparative Study: Non-Surgical Spinal Decompression and Spinal Manipulative Therapy- Utilizing a Quantifiable Musculoskeletal Functional Assessment Risk Analysis Tool (MSDR®) in Patients With Chronic Low Back Pain
NCT ID: NCT00732394
Last Updated: 2008-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2008-08-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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MedAppraise, Inc.
INDUSTRY
Responsible Party
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Back2Life of Florida, Inc.
Principal Investigators
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Eric K Groteke, DC
Role: STUDY_CHAIR
MedAppraise, Inc.
Luis Crespo, MD
Role: PRINCIPAL_INVESTIGATOR
Crespo and Associates
Mark Scinico, MD
Role: STUDY_DIRECTOR
Concentra
Damon J Stafford, DC
Role: PRINCIPAL_INVESTIGATOR
Back2Life of Florida, Inc.
Locations
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Back2Life of Florida, Inc.
Clearwater, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Tammy Cravotta
Role: primary
Matt Erickson, DC
Role: backup
Related Links
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Other Identifiers
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TCT06-002
Identifier Type: -
Identifier Source: org_study_id