Duration of Spinal Manipulation Effects as Influenced by Orthotics

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: foot orthotics; Device: Sham foot orthotic

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Logan College of Chiropractic/University Programs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Foot Levelers flat insoles similar to Full Length Ultra Step

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Logan College of Chiropractic
• Investigators: Principal Investigator: Katharine Conable, DC, Logan College of Chiropractic/University Programs; Principal Investigator: Anthony Rosner, PhD, International College of Applied Kinesiology

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: October 10, 2012
• First Posted (ESTIMATE): October 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2012
• Last Update Submitted That Met QC Criteria: October 10, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Low Back Pain; Chronic; Chiropractic; Applied Kinesiology; Orthotic Device; Manual Muscle Testing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LCC-12-RD0519110317