Status:
UNKNOWN
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
Lead Sponsor:
MedAppraise, Inc.
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00732394
Start Date
August 1 2008
End Date
January 1 2010
Last Update
August 12 2008
Active Locations (1)
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1
Back2Life of Florida, Inc.
Clearwater, Florida, United States, 33761