Duration of Spinal Manipulation Effects as Influenced by Orthotics

Logan College of Chiropractic41 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Low Back Pain

Interventions

foot orthoticsDEVICE

Experimental wore experimental orthotics throughout the study period as much of the day as possible.

Sham foot orthoticDEVICE

Control group wore sham insoles as much of the time as possible for the duration of the study period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Logan College of Chiropractic/University Programs

Chesterfield, Missouri, United States

Outcomes

Primary Outcomes

Quadruple Visual Analog Pain Scale

Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.

Time frame: Six weeks

Roland-Morris Questionnaire

Questionnaire listing activities of daily living, impacted by low back pain.

Time frame: Six weeks

Secondary Outcomes

Number of fixated vertebral levels

Number of vertebral levels found to be fixated as determined by motion palpation and vertebral challenge.

Time frame: 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.

Time frame: Six weeks

Data from ClinicalTrials.gov

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