Orthotic Use for Chronic Low Back Pain
|ClinicalTrials.gov Identifier: NCT00976664|
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : November 17, 2014
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment|
|Chronic Low Back Pain||Device: Shoe orthotic Device: Shoe Orthotic Wait Group|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Orthotic Use for Chronic Low Back Pain|
|Study Start Date :||June 2009|
|Primary Completion Date :||February 2010|
|Study Completion Date :||February 2010|
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.
- Visual Analog Scale (VAS) [ Time Frame: 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) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|