Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain
TerminatedNot applicableNCT01865539
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 with chronic lower back pain who receive the custom foot orthotics will show greater improvements in pain and disability associated with the chronic lower back pain than those who receive the sham orthotic.
Study details
- Official title
- Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain
- Conditions
- Interventions
- Device: Custom Foot Orthotic
- Device: Sham Orthotic
- Sponsor
- Canandaigua VA Medical Center
- Collaborators
- Foot Levelers, Inc.; Northeast College of Health Sciences
- Start date
- 2013-05
- Primary completion
- 2016-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01865539