A Randomized Prospective Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Cleveland Clinic Florida.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Integral Orthopedics Inc.
Information provided by:
Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT00553540
First received: November 2, 2007
Last updated: June 30, 2008
Last verified: June 2008
  Purpose

The purpose of this study is to determine whether orthopedic spinal supports are effective in the treatment of low back pain.


Condition Intervention
Low Back Pain
Device: Back supports

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain

Resource links provided by NLM:


Further study details as provided by Cleveland Clinic Florida:

Primary Outcome Measures:
  • Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oswestry Disability Index; SF-36 Quality of Life Measurement Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2006
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Patients in this group will receive physical therapy and posture education for low back pain
Active Comparator: Test Group
Patients in this group will receive spinal supports in addition to physical therapy and posture education for low back pain
Device: Back supports
The spinal supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs.
Other Name: Moller Back Support System

Detailed Description:

Back pain is a common and expensive medical condition. Although rarely life-threatening, back disorders are a major cause of pain, disability, and social cost affecting the quality of life in most patients. Although primary care providers routinely treat back pain, little is known about how often primary care providers manage occupation-related symptoms and how outcomes compare with other treatment modalities. Treatment outcomes utilizing a non-operative treatment paradigm have not been adequately studied. This paradigm consists of treating patients sequentially with analgesics, physical therapy, use of back supports, caudal epidural steroid injections, or surgical referral. The use of spinal supports as a complimentary treatment along with physical therapy and posture education is promising.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must present with clinical symptoms of low back pain and evaluated by the study physician
  • Visual Analog Score (VAS) for Pain >6 in response to the following question: Circle one number (from 0 = no pain to 10 = worst pain) "How would you rate the worst pain you experienced in last week."
  • Patients must have x-ray and or an MRI film for diagnostic evaluation based on physician judgment.
  • Age >18; both male and female
  • Pain duration >3 months

Exclusion Criteria:

  • Prior use of opioids, physical therapy, epidural injections for back pain or ongoing chiropractor care and or acupuncture treatment
  • Moderate to severe arthritis of the spine/ knee or hip that might severely compromise ambulation and or posture
  • Patients with diagnosed lumbar canal stenosis
  • Serious concomitant medical illness (i.e., heart disease)
  • Obese patients (twice the width of the Moller Orthopedic Back Support)
  • Patients with moderate to severe scoliosis
  • Past or present existence of a movement disorder, e.g., Parkinsonism, or any neurological disease that might affect ambulation and or postural changes History of osteoporosis
  • Severe psychiatric disorder
  • Prior spine surgery
  • Multiple vertebral compression fractures with kyphosis
  • Past or present workmen's compensation claim, SSI disability, or ongoing litigation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553540

Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Cleveland Clinic Florida
Integral Orthopedics Inc.
Investigators
Study Director: Vinod K Podichetty, MD,MS Cleveland Clinic Florida
Principal Investigator: David Westerdahl, MD Cleveland Clinic Florida
  More Information

Publications:
Andersson GBJ. The epidemiology of spinal disorders. In: Frymoyer JW, Ducker TB, Hadler NM, et al, eds. The Adult Spine: Principles and Practice. Philadelphia: Lippincott-Raven, 1997:93-141.
Frymoyer JW, Durett CL. The economics of spinal disorders. In: Frymoyer JW, Ducker TB, Hadler NM, et al, eds. The Adult Spine: Principles and Practice. Philadelphia: Lippincott-Raven, 1997:143-150.
Bernard BP. Introduction. In: Bernard BP, ed. Musculoskeletal Disorders and Workplace Factors. Cincinnati: National Institute for Occupational Safety and Health, Centers for Disease Control, U.S. Department of Health and Human Services, 1997.

Responsible Party: Vinod Podichetty, Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT00553540     History of Changes
Other Study ID Numbers: IOI
Study First Received: November 2, 2007
Last Updated: June 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Cleveland Clinic Florida:
backache
low backpain
sciatica

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014