Chronic Low Back Pain
Conditions
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 a three month period. The hypothesis of this study is that custom orthotic intervention will improve the patients' low back pain and dysfunction symptoms.
Interventions
DEVICEShoe orthotic
Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.
DEVICEShoe Orthotic Wait Group
This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.
Sponsors
Foot Levelers, Inc.
National University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females must be at least 18 years old. 2. Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain. 3. Symptoms must have been present for at least three months.
Exclusion criteria
1. Use of custom-made shoe orthotics in the past year 2. Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion. 3. 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. 4. Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study. 5. Current or future litigation for low back pain. 6. Chronic pain other then low back pain such as fibromyalgia 7. Low back surgery in last six months. 8. Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use. 9. Peripheral neuropathy due to disorders such as diabetes. 10. Low back or leg pain that is not reproducible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | Randomization, Week 6, and Week 12 | This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain. |
| Oswestry Disability Index (ODI) | Randomization, Week 6, and Week 12 | This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table. |
Countries
United States
Participant flow
Recruitment details
We recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area.
Pre-assignment details
143 people were screened by phone, eligible patients (58) attended a baseline visit. Subjects were eligible if they were 18+ years of age and symptomatic with pain between T12-S1 joints with or without radiating pain for at least 3 months. Patients were randomized to a treatment group receiving custom-made orthotics or a wait-list control group.
Participants by arm
| Arm | Count |
|---|---|
| Orthotic Group This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks. | 25 |
| Wait Group This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Orthotic Group | Wait Group | Total |
|---|---|---|---|
| Age, Customized Age, Customized | 51 years STANDARD_DEVIATION 16 | 53 years STANDARD_DEVIATION 16 | 52 years STANDARD_DEVIATION 16 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Oswestry Disability Index (ODI)
This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.
Time frame: Randomization, Week 6, and Week 12
Population: Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthotic Group | Oswestry Disability Index (ODI) | Randomization | 10.0 units on a scale | Standard Deviation 4.9 |
| Orthotic Group | Oswestry Disability Index (ODI) | Week 6 | 6.2 units on a scale | Standard Deviation 5.2 |
| Orthotic Group | Oswestry Disability Index (ODI) | Week 12 | 6.1 units on a scale | Standard Deviation 5.3 |
| Wait Group | Oswestry Disability Index (ODI) | Randomization | 10.4 units on a scale | Standard Deviation 5.8 |
| Wait Group | Oswestry Disability Index (ODI) | Week 6 | 10.2 units on a scale | Standard Deviation 5.4 |
| Wait Group | Oswestry Disability Index (ODI) | Week 12 | 8.9 units on a scale | Standard Deviation 5.5 |
p-value: 0.002Wilcoxon (Mann-Whitney)
p-value: 0.0336Wilcoxon (Mann-Whitney)
Primary
Visual Analog Scale (VAS)
This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.
Time frame: Randomization, Week 6, and Week 12
Population: Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Orthotic Group | Visual Analog Scale (VAS) | Randomization | 5.0 units on a scale | Standard Deviation 2.2 |
| Orthotic Group | Visual Analog Scale (VAS) | Week 6 | 2.8 units on a scale | Standard Deviation 2.6 |
| Orthotic Group | Visual Analog Scale (VAS) | Week 12 | 2.7 units on a scale | Standard Deviation 2.5 |
| Wait Group | Visual Analog Scale (VAS) | Randomization | 4.3 units on a scale | Standard Deviation 1.9 |
| Wait Group | Visual Analog Scale (VAS) | Week 6 | 4.1 units on a scale | Standard Deviation 2.3 |
| Wait Group | Visual Analog Scale (VAS) | Week 12 | 2.9 units on a scale | Standard Deviation 2.3 |
p-value: 0.0007Wilcoxon (Mann-Whitney)
p-value: 0.3913Wilcoxon (Mann-Whitney)