Duration of Spinal Manipulation Effects as Influenced by Orthotics

NCT01704807 | Completed Phase 1

• 1 other identifier: LCC-12-RD0519110317
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Chronic; Orthotic Device; Applied Kinesiology; Manual Muscle Testing; Chiropractic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of fixated vertebral levels

  Six weeks

• Number of tested muscles grade 4 and below

  Six weeks

Study Arms (2)

Intervention, Custom Orthotics

ACTIVE COMPARATOR

Wearing custom foot orthotics

Device: foot orthotics

Sham Foot Orthotic

SHAM COMPARATOR

Wearing sham or flat shoe insoles

Device: Sham foot orthotic

Interventions

foot orthotics DEVICE

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

Also known as: Foot Levelers, Full length ultra step foot orthotics

Intervention, Custom Orthotics

Sham foot orthotic DEVICE

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

Also known as: Foot Levelers flat insoles similar to Full Length Ultra Step

Sham Foot Orthotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Logan College of Chiropractic: lead

Study Sites (1)

Logan College of Chiropractic/University Programs

Chesterfield, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Katharine Conable, DC

  Logan College of Chiropractic/University Programs

  PRINCIPAL INVESTIGATOR

• Anthony Rosner, PhD

  International College of Applied Kinesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: October 11, 2012
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

US (1)