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

Not Applicable

• Conditions: Chronic Low Back Pain

• Registration Number: NCT00732394
• Lead Sponsor: MedAppraise, Inc.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-08
• Study First Submitted: 2008-08-08
• Study First Submitted QC: 2008-08-08
• Last Update Submitted: 2008-08-08
• Study First Posted: 2008-08-12
• Last Update Posted: 2008-08-12
• Primary Completion: 2009-08
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To document the musculoskeletal profile of patients with low back pain	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Back2Life of Florida, Inc.; 🇺🇸 Clearwater, Florida, United States