Back Pain Lower Back Chronic Clinical Trial
Official title:
Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain
NCT number | NCT01865539 |
Other study ID # | MIRB00558 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | June 2016 |
Verified date | April 2022 |
Source | Canandaigua VA Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 51 |
Est. completion date | June 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Canandaigua VA Medical Center | Foot Levelers, Inc., New York Chiropractic College |
United States,
Sahar T, Cohen MJ, Uval-Ne'eman V, Kandel L, Odebiyi DO, Lev I, Brezis M, Lahad A. Insoles for prevention and treatment of back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine (Phila Pa 1976). 2009 Apr 20;34(9):924-33. doi: 10.1097/BRS.0b013e31819f29be. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) | Visual Analog Scales (VAS): VAS is rated from 0 to 100mm with 0 being no pain at all and 100mm being the worst pain imaginable. The test has shown test-retest reliability, intra-examiner reliability and inter-examiner reliability. | 24 weeks. | |
Secondary | Modified Oswestry Disability Index (mODI) | The back pain specific, self-rating scale evaluates the degree of functional impairment that a patient is experiencing in a number of activities of daily living. Oswestry is scored on a scale of 0-50 with 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled | 24 weeks. | |
Secondary | Patient Reported Outcome Measurement Information System (PROMIS) Physical Function | For PROMIS measures, higher scores equals more of the concept being measured (more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. Specifically for PROMIS Physical function 50 indicates the reference population, therefore a score of 40 would be lower physical function. | 24 weeks. |
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