Chronic Low Back PainNCT00732394
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
A study testing MSDR in people with Chronic Low Back Pain, run by MedAppraise, Inc. at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- MSDR
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- ->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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Back2Life of Florida, Inc.
Clearwater, Florida, 33761
Tammy Cravotta, 727-797-0500
Matt Erickson, DC, 727-797-0500
About this study
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.
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
- Being tested
- MSDR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSDROther
Also called Musculoskeletal Disorder Reporting Tool
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the musculoskeletal profile of patients with low back pain
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedAppraise, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric K Groteke, DC, Study chair, MedAppraise, Inc.Luis Crespo, MD, Principal investigator, Crespo and AssociatesMark Scinico, MD, Study director, ConcentraDamon J Stafford, DC, Principal investigator, Back2Life of Florida, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732394
- Sponsor's protocol ID
- TCT06-002
- Status last verified
- Aug 2008
- First submitted
- 8 Aug 2008
- Last updated
- 12 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00732394
- Acronym / sponsor ID
- TCT06-002
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MedAppraise, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSDRAlso: Musculoskeletal Disorder Reporting ToolThe 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. | Other | – |
Primary outcome
To document the musculoskeletal profile of patients with low back pain
Time frame: 1 year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2008.
- MSDRLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric K Groteke, DC study chair
MedAppraise, Inc.
Luis Crespo, MD principal investigator
Crespo and Associates
Mark Scinico, MD study director
Concentra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSDR in people with Chronic Low Back Pain, run by MedAppraise, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric K Groteke, DC (727-797-0500, egroteke@medappraise.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To document the musculoskeletal profile of patients with low back pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2008.