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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00732394
Recruitment Status : Unknown
Verified August 2008 by MedAppraise, Inc..
Recruitment status was:  Recruiting
First Posted : August 12, 2008
Last Update Posted : August 12, 2008
Information provided by:
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

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: MSDR Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: This is a Study is for the Purpose of Quantifying Function of the Back and Lower Extremities, and to Assess the Inter-Regional Biomechanical Relationships of the Neck, Upper Extremities, Back, and Lower Extremities in Patients Suffering From Chronic Low Back Pain.
Study Start Date : August 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Intervention Details:
    Other: 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 Name: Musculoskeletal Disorder Reporting Tool

Primary Outcome Measures :
  1. To document the musculoskeletal profile of patients with low back pain [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00732394

Contact: Eric K Groteke, DC 727-797-0500
Contact: Damon J Stafford, DC 727-797-0500

United States, Florida
Back2Life of Florida, Inc. Recruiting
Clearwater, Florida, United States, 33761
Contact: Tammy Cravotta    727-797-0500      
Contact: Matt Erickson, DC    727-797-0500      
Sponsors and Collaborators
MedAppraise, Inc.
Study Chair: Eric K Groteke, DC MedAppraise, Inc.
Principal Investigator: Luis Crespo, MD Crespo and Associates
Study Director: Mark Scinico, MD Concentra
Principal Investigator: Damon J Stafford, DC Back2Life of Florida, Inc.

Additional Information:
MSDR  This link exits the site

Responsible Party: Damon J. Stafford, D.C., Back2Life of Florida, Inc. Identifier: NCT00732394     History of Changes
Other Study ID Numbers: TCT06-002
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: August 12, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms