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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

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MSDR
Sponsored by
MedAppraise, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Back2Life of Florida, Inc.Recruiting

Outcomes

Primary Outcome Measures

To document the musculoskeletal profile of patients with low back pain

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.

Full Information

First Posted
August 8, 2008
Last Updated
August 8, 2008
Sponsor
MedAppraise, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00732394
Brief 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
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

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
MedAppraise, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
MSDR
Other Intervention Name(s)
Musculoskeletal Disorder Reporting Tool
Intervention Description
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 Information:
Title
To document the musculoskeletal profile of patients with low back pain
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric K Groteke, DC
Phone
727-797-0500
Email
egroteke@medappraise.com
First Name & Middle Initial & Last Name or Official Title & Degree
Damon J Stafford, DC
Phone
727-797-0500
Email
drdamon7@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric K Groteke, DC
Organizational Affiliation
MedAppraise, Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luis Crespo, MD
Organizational Affiliation
Crespo and Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Scinico, MD
Organizational Affiliation
Concentra
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Damon J Stafford, DC
Organizational Affiliation
Back2Life of Florida, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Back2Life of Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Cravotta
Phone
727-797-0500
First Name & Middle Initial & Last Name & Degree
Matt Erickson, DC
Phone
727-797-0500

12. IPD Sharing Statement

Learn more about this trial

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

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