Back to resultsOrthotic Use for Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shoe orthotic
Shoe Orthotic Wait Group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Males and females must be at least 18 years old.
- Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
- Symptoms must have been present for at least three months.
Exclusion Criteria:
- Use of custom-made shoe orthotics in the past year
- Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
- Active conservative care (such as physical therapy or chiropractic care) for the low back received in the last six months (excluding the use of oral medications or daily at-home exercises for general well-being). We do not want to over-treat the patient or have any cross-over effects within this study from previous treatment.
- Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
- Current or future litigation for low back pain.
- Chronic pain other then low back pain such as fibromyalgia
- Low back surgery in last six months.
- Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use.
- Peripheral neuropathy due to disorders such as diabetes.
- Low back or leg pain that is not reproducible.
Sites / Locations
- National University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Orthotic group
Shoe Orthotic Wait group
Arm Description
Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.
The group serves as a cross-over control group. Subjects are asked to avoid any new therapies for the first 6 weeks of the 12 week study and during the last 6 weeks they are fitted for the custom-made shoe orthotics.
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS)
This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.
Oswestry Disability Index (ODI)
This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.
Secondary Outcome Measures
Full Information
NCT ID
NCT00976664
First Posted
September 11, 2009
Last Updated
March 30, 2017
Sponsor
National University of Health Sciences
Collaborators
Foot Levelers, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00976664
Brief Title
Orthotic Use for Chronic Low Back Pain
Official Title
Orthotic Use for Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Health Sciences
Collaborators
Foot Levelers, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to determine the change in perceived levels of pain and dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe orthotics for a three month period. The hypothesis of this study is that custom orthotic intervention will improve the patients' low back pain and dysfunction symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orthotic group
Arm Type
Active Comparator
Arm Description
Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.
Arm Title
Shoe Orthotic Wait group
Arm Type
Other
Arm Description
The group serves as a cross-over control group. Subjects are asked to avoid any new therapies for the first 6 weeks of the 12 week study and during the last 6 weeks they are fitted for the custom-made shoe orthotics.
Intervention Type
Device
Intervention Name(s)
Shoe orthotic
Intervention Description
Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.
Intervention Type
Device
Intervention Name(s)
Shoe Orthotic Wait Group
Intervention Description
This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.
Time Frame
Randomization, Week 6, and Week 12
Title
Oswestry Disability Index (ODI)
Description
This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.
Time Frame
Randomization, Week 6, and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females must be at least 18 years old.
Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
Symptoms must have been present for at least three months.
Exclusion Criteria:
Use of custom-made shoe orthotics in the past year
Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
Active conservative care (such as physical therapy or chiropractic care) for the low back received in the last six months (excluding the use of oral medications or daily at-home exercises for general well-being). We do not want to over-treat the patient or have any cross-over effects within this study from previous treatment.
Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
Current or future litigation for low back pain.
Chronic pain other then low back pain such as fibromyalgia
Low back surgery in last six months.
Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use.
Peripheral neuropathy due to disorders such as diabetes.
Low back or leg pain that is not reproducible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrilyn Cambron, DC, MPH, PhD
Organizational Affiliation
National University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Health Sciences
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
12. IPD Sharing Statement
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Orthotic Use for Chronic Low Back Pain
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