Clinical trial NCT00732394: 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
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: MedAppraise, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


Eligibility 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

Primary outcomes:
measure: To document the musculoskeletal profile of patients with low back pain
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Back2Life of Florida, Inc.
state: Florida
Study officials:
affiliation: MedAppraise, Inc.
name: Eric K Groteke, DC
role: STUDY_CHAIR
affiliation: Crespo and Associates
name: Luis Crespo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Concentra
name: Mark Scinico, MD
role: STUDY_DIRECTOR
affiliation: Back2Life of Florida, Inc.
name: Damon J Stafford, DC
role: PRINCIPAL_INVESTIGATOR
References: