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

This study has been completed.
Integral Orthopedics Inc.
Information provided by (Responsible Party):
The Cleveland Clinic ( Cleveland Clinic Florida ) Identifier:
First received: November 2, 2007
Last updated: April 11, 2017
Last verified: June 2008
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
Intervention Model: Parallel Assignment
Masking: No masking
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 The Cleveland Clinic:

Primary Outcome Measures:
  • Pain [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Oswestry Disability Index; SF-36 Quality of Life Measurement Scale [ Time Frame: 6 months ]

Enrollment: 50
Study Start Date: October 2006
Study Completion Date: August 2009
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 / back supports in addition to physical therapy and posture education for low back pain
Device: Back supports
The spinal / back 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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00553540

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

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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cleveland Clinic Florida Identifier: NCT00553540     History of Changes
Other Study ID Numbers: IOI
Study First Received: November 2, 2007
Last Updated: April 11, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
low backpain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on April 24, 2017