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

Chronic Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00732394
• Other study ID #: TCT06-002
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2008
• Last updated: August 8, 2008
• Start date: August 2008
• Est. completion date: January 2010

Study information

• Verified date: August 2008
• Source: MedAppraise, Inc.
• Contact: Eric K Groteke, DC
• Phone: 727-797-0500
• Email: egroteke[@]medappraise.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Back2Life of Florida, Inc.	Clearwater	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MedAppraise, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To document the musculoskeletal profile of patients with low back pain		1 year	No
Secondary	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	No

External Links

•   MSDR