Orthotic Use for Chronic Low Back Pain

NCT ID: NCT00976664

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orthotic group

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

Group Type: ACTIVE_COMPARATOR

Shoe orthotic

Intervention Type: DEVICE

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.

Group Type: OTHER

Shoe Orthotic Wait Group

Intervention Type: DEVICE

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

Interventions

Shoe orthotic

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foot Levelers, Inc.

INDUSTRY

Sponsor Role: collaborator

National University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jerrilyn Cambron, DC, PhD

Research and Professor in Dept of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerrilyn Cambron, DC, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Health Sciences

Locations

National University of Health Sciences

Lombard, Illinois, United States

Countries

United States

Other Identifiers

NUHS IRB H-0904

Identifier Type: -

Identifier Source: org_study_id