Orthotic Use for Chronic Low Back Pain

National University of Health Sciences

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Wait List; Other: Orthotics Plus Chiropractic Care; Other: Orthotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02089750

NUHS IRB_H-1203

Details and patient eligibility

About

The goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer subjects who have chronic low back pain.

The hypothesis of this study is that custom-made shoe will improve patients' low back pain and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will further improve patients' low back pain and dysfunction while maintaining that improvement during the one year study follow-up period.

Specific Aims:

1. To determine the changes in perceived pain levels (Numeric Pain Rating Scale) and dysfunction (Oswestry Disability Index) in patients with chronic low back pain after six weeks of custom-made shoe orthotic use with or without chiropractic care as compared to no care.
2. To determine the changes in perceived pain levels and dysfunction in patients with chronic low back pain after twelve weeks of custom-made shoe orthotic use.
3. To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12 months following the 12 week treatment period.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least 18 years old
2. Subjects must be symptomatic with current pain between T12 and the SI joints with or without radiating pain at an average score of 4 or higher on the NPRS scale
3. Symptoms must have been present for at least three months

Exclusion criteria

1. Use of custom-made orthotics in the past 6 months
2. Ongoing active conservative care (such as physical therapy or chiropractic care) for the low back, leg, or foot received in the past 6 months (excluding the use of oral medications or daily at-home exercises for general well-being).
3. Current or future litigation for any healthcare concern
4. Not fluent or literate in the English language. We will not be able to provide multiple translators within this study
5. Brain disorders (e.g., dementia, Alzheimers Disease , etc.) that would lead to difficulty in questionnaire completion
6. Chronic pain other than low back pain, such as fibromyalgia or multiple sclerosis
7. Clinically significant chronic inflammatory spinal arthritis
8. Spinal pathology or fracture
9. Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome
10. History of bleeding disorder
11. Known arterial aneurysm
12. Previous lumbar spine surgery
13. Severe skeletal deformity of the foot
14. Peripheral neuropathy due to disorders such as diabetes
15. Low back pain that is not reproducible
16. Current pregnancy
17. Other conditions that may affect the subjects' ability to participate throughout the duration of the study or exclude patients from participation in the study, including contraindications to orthotic use or chiropractic spinal manipulations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups

Orthotics

Active Comparator group

Description:

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

Treatment:

Other: Orthotics

Orthotics Plus Chiropractic Care

Active Comparator group

Description:

Subjects are asked to wear custom-made shoe orthotics for a 12 week study period in addition to receiving Chiropractic Care 1-4 times per week during the first 6 weeks of the 12 week study period.

Treatment:

Other: Orthotics Plus Chiropractic Care

Other: Orthotics

Wait List

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 six weeks they are fitted for the custom-made shoe orthotics.

Treatment:

Other: Wait List

Other: Orthotics