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 recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by MedAppraise, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
MedAppraise, Inc.
ClinicalTrials.gov Identifier:
NCT00732394
First received: August 8, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 Intervention
Chronic Low Back Pain
Other: MSDR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by MedAppraise, Inc.:

Primary Outcome Measures:
  • To document the musculoskeletal profile of patients with low back pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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 Names:
    • Musculoskeletal Disorder Reporting Tool
    • MSDR
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732394

Contacts
Contact: Eric K Groteke, DC 727-797-0500 egroteke@medappraise.com
Contact: Damon J Stafford, DC 727-797-0500 drdamon7@aol.com

Locations
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.
Investigators
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.
  More Information

No publications provided

Responsible Party: Damon J. Stafford, D.C., Back2Life of Florida, Inc.
ClinicalTrials.gov Identifier: NCT00732394     History of Changes
Other Study ID Numbers: TCT06-002
Study First Received: August 8, 2008
Last Updated: August 8, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014