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N/A N=50 Randomized Treatment

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

Low Back Pain

Enrolled (actual)
50
Serious AEs
Results posted
Nov 2019
Primary outcome: Primary: Change in Low Back Pain — 2.58; 1.80 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Back supports (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Cleveland Clinic Florida
Primary completion
Aug 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Low Back Pain
2.58; 1.80

Summary

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

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00553540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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