Orthotic Use for Chronic Low Back Pain
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|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||Phase|
|Chronic Low Back Pain||Device: Shoe orthotic Device: Shoe Orthotic Wait Group||Not Applicable|
|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|
|Actual Primary Completion Date :||February 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|