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Completed

NCT Number: NCT00553540

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Back supports

Device

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 names: Moller Back Support System

Primary outcomes

  1. Change in Low Back Pain

    Time frame: 6 months

    numeric pain scale was used to determine pain at 1 week intervals starting from week 1 to week 24. Pain scores were determined by the numeric pain score of 1 to 10 (1 being the least painful to 10 being the highest level of pain) then summed up and averaged at 24 time points at 1 week intervals starting from week 1 to week 24.

Sponsors and collaborators

Lead sponsor

Cleveland Clinic Florida

Other

Collaborators

  • Integral Orthopedics Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 5, 2007
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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