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

NCT00732394 | Unknown DMC

• 1 other identifier: TCT06-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• To document the musculoskeletal profile of patients with low back pain

  1 year

Secondary Outcomes (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.

  1 year

Interventions

MSDR OTHER

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.

Also known as: Musculoskeletal Disorder Reporting Tool

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MedAppraise, Inc.: lead

Study Sites (1)

Back2Life of Florida, Inc.

Clearwater, Florida, 33761, United States

RECRUITING

Related Links

• MSDR

Study Officials

• Eric K Groteke, DC

  MedAppraise, Inc.

  STUDY CHAIR

• Luis Crespo, MD

  Crespo and Associates

  PRINCIPAL INVESTIGATOR

• Mark Scinico, MD

  Concentra

  STUDY DIRECTOR

• Damon J Stafford, DC

  Back2Life of Florida, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric K Groteke, DC

CONTACT

727-797-0500; egroteke@medappraise.com

Damon J Stafford, DC

CONTACT

727-797-0500; drdamon7@aol.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: January 1, 2010
• Last Updated: August 12, 2008

Record last verified: 2008-08

Locations

US (1)