Orthotic Use for Chronic Low Back Pain

National University of Health Sciences

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Device: Shoe orthotic; Device: Shoe Orthotic Wait Group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00976664

NUHS IRB H-0904

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Orthotic group

Active Comparator group

Description:

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

Treatment:

Device: Shoe orthotic

Shoe Orthotic Wait group

Other group

Description:

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.

Treatment:

Device: Shoe Orthotic Wait Group