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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: November 13, 2014
Last verified: November 2014
  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
Device: Shoe Orthotic Wait Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.
Investigators
Principal Investigator: Jerrilyn Cambron, DC, MPH, PhD National University of Health Sciences
  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
Results First Received: April 30, 2012
Last Updated: November 13, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014