Recruiting

Spinal Decompression & SMT

Sponsor:

MedAppraise, Inc.

Code:

NCT00732394

Conditions

Chronic Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

MSDR

Study Details

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

Conditions

Chronic Low Back Pain

Study ID

NCT00732394

Start date

Aug, 2008

Status verified date

Aug, 2008

Completion date

Jan, 2010

Anticipated

Primary completion date

Aug, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Eric K Groteke, DC

727-797-0500egroteke@medappraise.com

Damon J Stafford, DC

727-797-0500drdamon7@aol.com

Locations

Back2Life of Florida, Inc.

Recruiting

Clearwater, Florida, United States, 33761

Contacts

Tammy Cravotta

727-797-0500

Matt Erickson, DC

727-797-0500

More Information

Sponsor

MedAppraise, Inc.

Last update posted

Aug 12, 2008

Last verified

Aug, 2008

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MedAppraise, Inc. on 2008-08-12.