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

First Received on August 8, 2008. No Changes Posted

Sponsor:	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

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:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

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:

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

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
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2012