Orthotic Use for Chronic Low Back Pain
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Orthotic Use for Chronic Low Back Pain|
- Visual Analog Scale (VAS) [ Time Frame: Randomization, Week 6, and Week 12 ] [ Designated as safety issue: No ]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) [ Time Frame: Randomization, Week 6, and Week 12 ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Orthotic group
Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.
Device: Shoe orthotic
Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.
Shoe Orthotic Wait group
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
This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976664
|United States, Illinois|
|National University of Health Sciences|
|Lombard, Illinois, United States, 60148|
|Principal Investigator:||Jerrilyn Cambron, DC, MPH, PhD||National University of Health Sciences|