Orthotic Use for Chronic Low Back Pain

Study Overview
=================
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.

Official Title
-----------------
Orthotic Use for Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Device: Shoe orthotic
* Device: Shoe Orthotic Wait Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females must be at least 18 years old. Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain. Symptoms must have been present for at least three months. Exclusion Criteria: Use of custom-made shoe orthotics in the past year Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion. 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. Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study. Current or future litigation for low back pain. Chronic pain other then low back pain such as fibromyalgia Low back surgery in last six months. Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use. Peripheral neuropathy due to disorders such as diabetes. Low back or leg pain that is not reproducible.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orthotic group<br>Subjects are asked to wear custom-made shoe orthotics for a 12 week study period. | Device: Shoe orthotic<br>* Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.<br>|
| Other: Shoe Orthotic Wait group<br>The group serves as a cross-over control group. Subjects are asked to avoid any new therapies for the first 6 weeks of the 12 week study and during the last 6 weeks they are fitted for the custom-made shoe orthotics. | Device: Shoe Orthotic Wait Group<br>* This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Randomization, Week 6, and Week 12 | 
| 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. | Randomization, Week 6, and Week 12 |