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Duration of Spinal Manipulation Effects as Influenced by Orthotics

NCT ID: NCT01704807

Last Updated: 2012-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intervention, Custom Orthotics

Wearing custom foot orthotics

Group Type ACTIVE_COMPARATOR

foot orthotics

Intervention Type DEVICE

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

Sham Foot Orthotic

Wearing sham or flat shoe insoles

Group Type SHAM_COMPARATOR

Sham foot orthotic

Intervention Type DEVICE

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

Interventions

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foot orthotics

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

Intervention Type DEVICE

Sham foot orthotic

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

Intervention Type DEVICE

Other Intervention Names

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Foot Levelers, Full length ultra step foot orthotics Foot Levelers flat insoles similar to Full Length Ultra Step

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Logan College of Chiropractic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katharine Conable, DC

Role: PRINCIPAL_INVESTIGATOR

Logan College of Chiropractic/University Programs

Anthony Rosner, PhD

Role: PRINCIPAL_INVESTIGATOR

International College of Applied Kinesiology

Locations

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Logan College of Chiropractic/University Programs

Chesterfield, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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LCC-12-RD0519110317

Identifier Type: -

Identifier Source: org_study_id