Orthotic Use for Chronic Low Back Pain

NCT00976664 | Completed Results

• 1 other identifier: NUHS IRB H-0904
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  Randomization, Week 6, and Week 12

• 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.

  Randomization, Week 6, and Week 12

Study Arms (2)

Orthotic group

ACTIVE COMPARATOR

Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.

Device: Shoe orthotic

Shoe Orthotic Wait group

OTHER

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

Interventions

Shoe orthotic DEVICE

Shoe orthotics are devices worn in the shoe to modify the patient's stance and gait.

Orthotic group

Shoe Orthotic Wait Group DEVICE

This group receives the custom-made shoe orthotics at week 6 of the 12 week treatment program rather than week 1.

Shoe Orthotic Wait group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Health Sciences: lead
• Foot Levelers, Inc.: collaborator

Study Sites (1)

National University of Health Sciences

Lombard, Illinois, 60148, United States

Location

MeSH Terms

Interventions

Foot Orthoses

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Limitations and Caveats

Subjects and clinicians were not blind to group. Subjects came from 1 region of the US, majority were white and \~50 years old. One type of orthotic was used as the only form of care. Several subjects felt discomfort/stiffness rather than pain.

Results Point of Contact

• Title: Dr. Jerrilyn Cambron
• Organization: National University of Health Sciences

jcambron@nuhs.edu

630-889-6536

Study Officials

• Jerrilyn Cambron, DC, MPH, PhD

  National University of Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Professor in Dept of Research

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 3, 2017
• Results First Posted: November 17, 2014

Record last verified: 2017-03

Locations

US (1)