N/A
Completed N=50
Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain
Source: ClinicalTrials.gov NCT00553540 ↗Enrolled (actual)
50
Serious AEs
—
Results posted
Nov 2019
Primary outcomePrimary: Change in Low Back Pain — 2.58; 1.80 units on a scale
Summary
The purpose of this study is to determine whether orthopedic spinal supports are effective in the treatment of low back pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Low Back Pain |
2.58; 1.80 | — |
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
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. Informational only — not medical advice.