Orthotic Use for Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Device: Shoe orthotic; Device: Shoe Orthotic Wait Group

• Registration Number: NCT00976664
• Lead Sponsor: National University of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2012-04-30
• Results First Submitted QC: 2014-11-13
• Results First Posted: 2014-11-17
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orthotic group	Shoe orthotic	Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.
Shoe Orthotic Wait group	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.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Randomization, Week 6, and Week 12	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.
Visual Analog Scale (VAS)	Randomization, Week 6, and Week 12	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.

Trial Locations

Locations (1)

National University of Health Sciences; 🇺🇸 Lombard, Illinois, United States