Duration of Spinal Manipulation Effects as Influenced by Orthotics
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|ClinicalTrials.gov Identifier: NCT01704807|
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: foot orthotics Device: Sham foot orthotic||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Duration of Spinal Manipulation Effects as Influenced by Orthotics|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Active Comparator: Intervention, Custom Orthotics
Wearing custom foot orthotics
Device: foot orthotics
Experimental wore experimental orthotics throughout the study period as much of the day as possible.
Other Name: Foot Levelers, Full length ultra step foot orthotics
Sham Comparator: Sham Foot Orthotic
Wearing sham or flat shoe insoles
Device: Sham foot orthotic
Control group wore sham insoles as much of the time as possible for the duration of the study period.
Other Name: Foot Levelers flat insoles similar to Full Length Ultra Step
- Quadruple Visual Analog Pain Scale [ Time Frame: Six weeks ]Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.
- Roland-Morris Questionnaire [ Time Frame: Six weeks ]Questionnaire listing activities of daily living, impacted by low back pain.
- Number of fixated vertebral levels [ Time Frame: Six weeks ]Number of vertebral levels found to be fixated as determined by motion palpation and vertebral challenge.
- Number of tested muscles grade 4 and below [ Time Frame: Six weeks ]Number of five muscles tested bilaterally, which tested grade 4 or below in manual muscle testing.
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): NCT01704807
|United States, Missouri|
|Logan College of Chiropractic/University Programs|
|Chesterfield, Missouri, United States, 63017|
|Principal Investigator:||Katharine Conable, DC||Logan College of Chiropractic/University Programs|
|Principal Investigator:||Anthony Rosner, PhD||International College of Applied Kinesiology|