Status:
COMPLETED
Orthotic Use for Chronic Low Back Pain
Lead Sponsor:
National University of Health Sciences
Collaborating Sponsors:
Foot Levelers, Inc.
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to determine the change in perceived levels of pain and dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe orthotics for...
Eligibility Criteria
Inclusion
- Males and females must be at least 18 years old.
- Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
- Symptoms must have been present for at least three months.
Exclusion
- Use of custom-made shoe orthotics in the past year
- Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
- Active conservative care (such as physical therapy or chiropractic care) for the low back received in the last six months (excluding the use of oral medications or daily at-home exercises for general well-being). We do not want to over-treat the patient or have any cross-over effects within this study from previous treatment.
- Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
- Current or future litigation for low back pain.
- Chronic pain other then low back pain such as fibromyalgia
- Low back surgery in last six months.
- Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use.
- Peripheral neuropathy due to disorders such as diabetes.
- Low back or leg pain that is not reproducible.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00976664
Start Date
June 1 2009
End Date
February 1 2010
Last Update
May 3 2017
Active Locations (1)
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1
National University of Health Sciences
Lombard, Illinois, United States, 60148