Spinal Decompression, Clinical Study

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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 study is currently recruiting participants.
Verified by MedAppraise, Inc., August 2008

Sponsored by: MedAppraise, Inc.

Information provided by: MedAppraise, Inc.
ClinicalTrials.gov Identifier: NCT00732394

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



MedlinePlus related topics: Back Pain

U.S. FDA Resources

Study Type: Interventional
Study Design: Screening, Randomized, Open Label, Parallel Assignment

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.


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.

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


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


MSDR


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


Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain




Additional relevant MeSH terms:
Nervous System Diseases



ClinicalTrials.gov processed this record on November 12, 2008