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Duration of Spinal Manipulation Effects as Influenced by Orthotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01704807
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Information provided by (Responsible Party):
Logan College of Chiropractic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: foot orthotics Device: Sham foot orthotic Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. Roland-Morris Questionnaire [ Time Frame: Six weeks ]
    Questionnaire listing activities of daily living, impacted by low back pain.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01704807

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United States, Missouri
Logan College of Chiropractic/University Programs
Chesterfield, Missouri, United States, 63017
Sponsors and Collaborators
Logan College of Chiropractic
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Principal Investigator: Katharine Conable, DC Logan College of Chiropractic/University Programs
Principal Investigator: Anthony Rosner, PhD International College of Applied Kinesiology
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Responsible Party: Logan College of Chiropractic Identifier: NCT01704807    
Other Study ID Numbers: LCC-12-RD0519110317
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Logan College of Chiropractic:
Low Back Pain
Orthotic Device
Applied Kinesiology
Manual Muscle Testing
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms