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

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.

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

Study Overview

• Status: Unknown
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: MSDR

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric K Groteke, DC; Phone Number: 727-797-0500; Email: egroteke@medappraise.com
• Study Contact Backup: Name: Damon J Stafford, DC; Phone Number: 727-797-0500; Email: drdamon7@aol.com

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States, 33761
      • Recruiting
      • Back2Life of Florida, Inc.
      • Contact: Tammy Cravotta; Phone Number: 727-797-0500
      • Contact: Matt Erickson, DC; Phone Number: 727-797-0500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To document the musculoskeletal profile of patients with low back pain	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ANTICIPATED): August 1, 2009
• Study Completion (ANTICIPATED): January 1, 2010

Study Registration Dates

• First Submitted: August 8, 2008
• First Submitted That Met QC Criteria: August 8, 2008
• First Posted (ESTIMATE): August 12, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 12, 2008
• Last Update Submitted That Met QC Criteria: August 8, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: TCT06-002