Orthotic Use for Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Orthotic Use for Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976664
• Other study ID #: NUHS IRB H-0904
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: November 13, 2014
• Start date: June 2009
• Est. completion date: February 2010

Study information

• Verified date: November 2014
• Source: National University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	National University of Health Sciences	Lombard	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
National University of Health Sciences	Foot Levelers, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No