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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00732394
• Date of registration: 08/08/2008
• Primary sponsor: MedAppraise, Inc.
• Public title: 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
• Scientific 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.
• Date of first enrolment: August 2008
• Target sample size: 200
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00732394
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Countries of recruitment

United States

Contacts

• Name: Tammy Cravotta

• Name: Eric K Groteke, DC

• Name: Damon J Stafford, DC
• Affiliation: Back2Life of Florida, Inc.

• Name: Mark Scinico, MD
• Affiliation: Concentra

• Name: Luis Crespo, MD
• Affiliation: Crespo and Associates

• Name: Eric K Groteke, DC
• Affiliation: MedAppraise, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Low Back Pain

Intervention(s)

Other: MSDR

Primary Outcome(s)

To document the musculoskeletal profile of patients with low back pain [Time Frame: 1 year]

Secondary Outcome(s)

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]

Secondary ID(s)

TCT06-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors