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Orthotic Use for Chronic Low Back Pain

This study has been completed.
Foot Levelers, Inc.
Information provided by (Responsible Party):
Jerrilyn Cambron, DC, PhD, National University of Health Sciences Identifier:
First received: September 11, 2009
Last updated: March 30, 2017
Last verified: March 2017
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.

Condition Intervention
Chronic Low Back Pain
Device: Shoe orthotic
Device: Shoe Orthotic Wait Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Orthotic Use for Chronic Low Back Pain

Resource links provided by NLM:

Further study details as provided by National University of Health Sciences:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) [ Time Frame: Randomization, Week 6, and Week 12 ]
    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) [ Time Frame: Randomization, Week 6, and Week 12 ]
    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.

Enrollment: 50
Study Start Date: June 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Orthotic group
Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.
Device: Shoe orthotic
Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.
Shoe Orthotic Wait group
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.
Device: Shoe Orthotic Wait Group
This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males and females must be at least 18 years old.
  2. Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
  3. Symptoms must have been present for at least three months.

Exclusion Criteria:

  1. Use of custom-made shoe orthotics in the past year
  2. Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
  3. 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.
  4. Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
  5. Current or future litigation for low back pain.
  6. Chronic pain other then low back pain such as fibromyalgia
  7. Low back surgery in last six months.
  8. Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use.
  9. Peripheral neuropathy due to disorders such as diabetes.
  10. Low back or leg pain that is not reproducible.
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Please refer to this study by its identifier: NCT00976664

United States, Illinois
National University of Health Sciences
Lombard, Illinois, United States, 60148
Sponsors and Collaborators
National University of Health Sciences
Foot Levelers, Inc.
Principal Investigator: Jerrilyn Cambron, DC, MPH, PhD National University of Health Sciences
  More Information

Responsible Party: Jerrilyn Cambron, DC, PhD, Research and Professor in Dept of Research, National University of Health Sciences Identifier: NCT00976664     History of Changes
Other Study ID Numbers: NUHS IRB H-0904
Study First Received: September 11, 2009
Results First Received: April 30, 2012
Last Updated: March 30, 2017

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 22, 2017