Duration of Spinal Manipulation Effects as Influenced by Orthotics

Study Overview
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Brief Summary
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Purpose of study: To assess the effects of wearing custom orthotics as opposed to placebo foot inserts on the duration of chiropractic correction of spinal fixations and muscle imbalances using applied kinesiology techniques.

Detailed Description
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Participants with chronic lower back pain of greater than one month duration will be randomized to receive custom foot orthotics or placebo flat inserts. Both groups will receive chiropractic treatment 5 times over the course of 4 weeks following receipt of orthotics. Subjects and treating doctor will be blind to the insert type. Patients will report present, average, best and worst pain at each visit, and complete a Roland-Morris questionnaire. Secondary outcome measures will be number of fixated vertebral levels identified by motion palpation and challenge and number of muscles testing grade 4 and below from a list of 5 muscles to be tested bilaterally before and after each treatment.

Official Title
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Duration of Spinal Manipulation Effects as Influenced by Orthotics

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: foot orthotics
* Device: Sham foot orthotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current low back pain episode present for one month or more No change in the past month in prescription medications affecting musculoskeletal pain Able to speak and understand English adequately to complete study forms Score on Roland-Morris questionnaire of 7.5 or higher or Average score on Chiropractic pain Index (Now, Average, and Worst scales from the Quadruple VAS pain scale) of 4 or higher. Exclusion Criteria: Use of foot orthotics within the past 12 months Previous lumbar spine surgery Ongoing treatment for lower back pain by other health care providers other than stable prescription medications affecting musculoskeletal pain. Clinically significant chronic inflammatory spinal arthritis Severe osteoporosis for which spinal manipulation is contraindicated Spinal pathology or fracture Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome History of bleeding disorder Known arterial aneurysm Pending/current litigation pertaining to back pain, including workers compensation claims Current pregnancy Lack of means of contacting which might preclude successful completion of study requirements Does not speak , read or understand English to an extent which would affect the subject's capacity to participate in informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention, Custom Orthotics<br>Wearing custom foot orthotics | Device: foot orthotics<br>* Experimental wore experimental orthotics throughout the study period as much of the day as possible.<br>* Other names: Foot Levelers, Full length ultra step foot orthotics;|
| Sham Comparator: Sham Foot Orthotic<br>Wearing sham or flat shoe insoles | Device: Sham foot orthotic<br>* Control group wore sham insoles as much of the time as possible for the duration of the study period.<br>* Other names: Foot Levelers flat insoles similar to Full Length Ultra Step;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadruple Visual Analog Pain Scale | Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable. | Six weeks | 
| Roland-Morris Questionnaire | Questionnaire listing activities of daily living, impacted by low back pain. | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of fixated vertebral levels | Number of vertebral levels found to be fixated as determined by motion palpation and vertebral challenge. | Six weeks | 
| Number of tested muscles grade 4 and below | Number of five muscles tested bilaterally, which tested grade 4 or below in manual muscle testing. | Six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Chronic, Orthotic Device, Applied Kinesiology, Manual Muscle Testing, Chiropractic