Duration of Spinal Manipulation Effects as Influenced by Orthotics

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT01704807

Run by

Logan College of Chiropractic

People needed

41

Starts

2011-09-01

Expected to finish

2012-03-01

Last updated by the study team

2012-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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