Back Pain Lower Back Chronic
Conditions
Keywords
Chronic lower back pain, Custom foot orthotics, Veterans
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 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.
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 pain who utilize either a custom foot orthotic or a sham orthotic. As part of this aim the investigators will build on the teams strength of recruiting and enrolling Veteran's with chronic lower back pain into a randomized trial. The investigators will collect baseline pain and disability measures utilizing validated tools. Once the patients are enrolled, utilizing the gold standard placebo controlled design the investigators will randomize patients to receive either a custom foot orthotic or a sham orthotic. The Veterans will then be assessed at 5, 12 and 24-weeks post baseline to evaluate differences in pain and disability. Based on previous studies on the effectiveness of custom foot orthotics the investigators hypothesize that that Veteran's who receive the custom orthotic will experience less pain and disability as compared to those who receive the sham orthotics. Specific Aim 2: To evaluate baseline characteristics of Veterans with chronic lower back pain predictive of responsiveness to custom foot orthotics including age, BMI, psychosocial characteristics and arch classification. Focusing on the Veterans who receive the custom foot orthotic, the investigators next examine the important characteristics that may predict those Veterans who are most likely to benefit from wearing custom foot orthotics. Assessing potential confounders or facilitators of effectiveness of the custom foot orthotic will allow the investigators to best describe potential mechanisms of responsiveness. The investigators have chosen previously described confounders to responsiveness to treatment of chronic lower back pain, specifically age, body mass index and psychosocial characteristics. This methodology is particularly important in a sham controlled trial to assess if effectiveness or lack of thereof, is a factor of the intervention or from other confounding variables. The investigators have also chosen to evaluate the arch classification based on the measurement of the Veterans arch; again this allows for specific recommendations concerning use of this product. Based on previous studies on the effectiveness of custom foot orthotics in addition to previous studies evaluating chronic lower back pain the investigators hypothesize that those Veterans who are older, have a higher BMI and greater fear avoidance belief scores will show less responsiveness to the custom foot orthotics as compared to those younger Veterans who have a lower BMI and lower fear avoidance belief scores. In addition based on previous biomechanical literature, the investigators feel that those Veterans with a lower arch will show the greatest responsiveness to the custom foot orthotic.
Interventions
DEVICECustom Foot Orthotic
Custom foot orthotic with custom design pads
DEVICESham Orthotic
Leather insert without the custom design pads
Sponsors
Foot Levelers, Inc.
Northeast College of Health Sciences
Canandaigua VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 24 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Oswestry Disability Index (mODI) | 24 weeks. | 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 |
| Patient Reported Outcome Measurement Information System (PROMIS) Physical Function | 24 weeks. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Custom Foot Orthotic Custom foot orthotic
Custom Foot Orthotic: Custom foot orthotic with custom design pads | 21 |
| Sham Orthotic Will be a sham orthotic that will be the same as the actual orthotic without the custom support pads.
Sham Orthotic: Leather insert without the custom design pads | 30 |
| Total | 51 |
Baseline characteristics
| Characteristic | Sham Orthotic | Custom Foot Orthotic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 21 Participants | 51 Participants |
| Age, Continuous | 55.1 years STANDARD_DEVIATION 10.5 | 58.2 years STANDARD_DEVIATION 8.1 | 56.4 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 30 participants | 21 participants | 51 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 26 Participants | 20 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 30 |
| other Total, other adverse events | 0 / 21 | 0 / 30 |
| serious Total, serious adverse events | 0 / 21 | 0 / 30 |
Outcome results
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.
Time frame: 24 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom Foot Orthotic | Visual Analog Scale (VAS) | 57.7 units on a scale | Standard Deviation 15.6 |
| Sham Orthotic | Visual Analog Scale (VAS) | 59.2 units on a scale | Standard Deviation 14.9 |
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
Time frame: 24 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom Foot Orthotic | Modified Oswestry Disability Index (mODI) | 40.3 units on a scale | Standard Deviation 13.2 |
| Sham Orthotic | Modified Oswestry Disability Index (mODI) | 37.1 units on a scale | Standard Deviation 12.2 |
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.
Time frame: 24 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom Foot Orthotic | Patient Reported Outcome Measurement Information System (PROMIS) Physical Function | 38.3 units on a scale | Standard Deviation 3.9 |
| Sham Orthotic | Patient Reported Outcome Measurement Information System (PROMIS) Physical Function | 40.9 units on a scale | Standard Deviation 4.1 |