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Orthotic Use for Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Foot Levelers, Inc.
Information provided by (Responsible Party):
Jerrilyn Cambron, DC, PhD, National University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00976664
First received: September 11, 2009
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Orthotic Use for Chronic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

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

Primary Outcome Measures:
  • The primary outcome measures in this study are the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI), measured at the randomization visit and the final three month visit. [ Time Frame: June 2009 - February 2010 ] [ Designated as safety issue: No ]

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 Device: Shoe orthotic
Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.
No Intervention: Wait group Device: Shoe orthotic
Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 SI 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976664

Locations
United States, Illinois
National University of Health Sciences
Lombard, Illinois, United States, 60148
Sponsors and Collaborators
National University of Health Sciences
Foot Levelers, Inc.
  More Information

No publications provided

Responsible Party: Jerrilyn Cambron, DC, PhD, Research and Professor in Dept of Research, National University of Health Sciences
ClinicalTrials.gov Identifier: NCT00976664     History of Changes
Other Study ID Numbers: NUHS IRB H-0904
Study First Received: September 11, 2009
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013