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Duration of Spinal Manipulation Effects as Influenced by Orthotics

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
foot orthotics
Sham foot orthotic
Sponsored by
Logan College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Chronic, Orthotic Device, Applied Kinesiology, Manual Muscle Testing, Chiropractic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Logan College of Chiropractic/University Programs

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Intervention, Custom Orthotics

Sham Foot Orthotic

Arm Description

Wearing custom foot orthotics

Wearing sham or flat shoe insoles

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2012
Last Updated
October 10, 2012
Sponsor
Logan College of Chiropractic
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1. Study Identification

Unique Protocol Identification Number
NCT01704807
Brief Title
Duration of Spinal Manipulation Effects as Influenced by Orthotics
Official Title
Duration of Spinal Manipulation Effects as Influenced by Orthotics
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Logan College of Chiropractic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Chronic, Orthotic Device, Applied Kinesiology, Manual Muscle Testing, Chiropractic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention, Custom Orthotics
Arm Type
Active Comparator
Arm Description
Wearing custom foot orthotics
Arm Title
Sham Foot Orthotic
Arm Type
Sham Comparator
Arm Description
Wearing sham or flat shoe insoles
Intervention Type
Device
Intervention Name(s)
foot orthotics
Other Intervention Name(s)
Foot Levelers, Full length ultra step foot orthotics
Intervention Description
Experimental wore experimental orthotics throughout the study period as much of the day as possible.
Intervention Type
Device
Intervention Name(s)
Sham foot orthotic
Other Intervention Name(s)
Foot Levelers flat insoles similar to Full Length Ultra Step
Intervention Description
Control group wore sham insoles as much of the time as possible for the duration of the study period.
Primary Outcome Measure Information:
Title
Quadruple Visual Analog Pain Scale
Description
Pain present, best worst and average on a scale of 0 to 10, with 10 being the worst imaginable.
Time Frame
Six weeks
Title
Roland-Morris Questionnaire
Description
Questionnaire listing activities of daily living, impacted by low back pain.
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Number of fixated vertebral levels
Description
Number of vertebral levels found to be fixated as determined by motion palpation and vertebral challenge.
Time Frame
Six weeks
Title
Number of tested muscles grade 4 and below
Description
Number of five muscles tested bilaterally, which tested grade 4 or below in manual muscle testing.
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine Conable, DC
Organizational Affiliation
Logan College of Chiropractic/University Programs
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Rosner, PhD
Organizational Affiliation
International College of Applied Kinesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Logan College of Chiropractic/University Programs
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States

12. IPD Sharing Statement

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Duration of Spinal Manipulation Effects as Influenced by Orthotics

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