Duration of Spinal Manipulation Effects as Influenced by Orthotics

Phase 1

Completed

• Conditions: Low Back Pain
• Interventions: Device: foot orthotics; Device: Sham foot orthotic

• Registration Number: NCT01704807
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-09
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-09-24
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-10
• Last Update Submitted: 2012-10-10
• Study First Posted: 2012-10-11
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention, Custom Orthotics	foot orthotics	Wearing custom foot orthotics
Sham Foot Orthotic	Sham foot orthotic	Wearing sham or flat shoe insoles

Primary Outcome Measures

Name	Time	Method
Quadruple Visual Analog Pain Scale	Six weeks	Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.
Roland-Morris Questionnaire	Six weeks	Questionnaire listing activities of daily living, impacted by low back pain.

Secondary Outcome Measures

Name	Time	Method
Number of fixated vertebral levels	Six weeks	Number of vertebral levels found to be fixated as determined by motion palpation and vertebral challenge.
Number of tested muscles grade 4 and below	Six weeks	Number of five muscles tested bilaterally, which tested grade 4 or below in manual muscle testing.

Trial Locations

Locations (1)

Logan College of Chiropractic/University Programs; 🇺🇸 Chesterfield, Missouri, United States