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Completed

NCT Number: NCT01704807

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.

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Key information

Conditions

Low Back Pain Back Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Logan College of Chiropractic/University Programs

Chesterfield, Missouri, 63017, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

foot orthotics

Device

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 foot orthotic

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Logan College of Chiropractic

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 11, 2012
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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