Status:
TERMINATED
Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain
Lead Sponsor:
Canandaigua VA Medical Center
Collaborating Sponsors:
Foot Levelers, Inc.
Northeast College of Health Sciences
Conditions:
Back Pain Lower Back Chronic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A randomized sham controlled trial evaluating the efficacy of the use of custom foot orthotics in veterans suffering from chronic lower back pain. The current study hypothesizes that those veterans wi...
Detailed Description
Specific Aim 1: Utilizing a gold standard sham controlled randomized trial design, we will evaluate the change in pain, back related disability and quality of life in Veterans with chronic lower back ...
Eligibility Criteria
Inclusion
- INCLUSION:
- Ages 18-65 Lower back pain ≥ 3 months in duration Pain elicited upon deep palpation of the lumbar erector spinae musculature Primary complaint of CLBP from L1 to Sacroiliac joint inclusive. Ability/willingness to use orthotics in their shoes Numeric Pain Rating Scale (NRPS) of ≥ 3
- 30 mm on the Visual Analogue Scale (VAS)
- 20% for the Modified Oswestry Disability Index (mODI)
- EXCLUSION:
- spinal surgery, spinal injections or injections in their feet within the past 6 months Inability to use orthotics in shoes Custom foot orthotics within the past 12 months Currently undergoing Chiropractic, Physical Therapy or Acupuncture treatment for their chronic lower back pain.
- evidence of cauda equina syndrome, spinal neoplasia or metastatic disease, destructive joint pathology such as rheumatoid arthritis bowel/bladder dysfunction (associated with the back pain) peripheral neuropathy or progressive lumbosacral radiculopathy, progressive myelopathy or neurogenic claudication.
- open workers compensation or no fault case.
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01865539
Start Date
May 1 2013
End Date
June 1 2016
Last Update
May 16 2022
Active Locations (1)
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1
Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center
Rochester, New York, United States, 14620