Clinical trial NCT02089750: Orthotic Use for Chronic Low Back Pain
Official title: Orthotic Use for Chronic Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Low Back Pain
Chiropractic
Shoe Orthotics
Lead sponsor: National University of Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: Foot Levelers, Inc.
First posted: 2014-03-18
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: This primary outcome measure will be collected at the Randomization Visit and Week 6.
measure: Modified Oswestry Disability Index (MODI)
timeFrame: This primary outcome measure will be collected at the Randomization Visit and Week 6.
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: This outcome will also be collected at secondary time points which include additional bi-weekly time points during care at Weeks 2, 4, 8, 10, and 12; as well as, 3, 6, and 12 months post-care.
measure: Modified Oswestry Disability Index (MODI)
timeFrame: This outcome will also be collected at secondary time points which include additional bi-weekly time points during care at Weeks 2, 4, 8, 10, and 12; as well as, 3, 6, and 12 months post-care.
Other outcomes:
Locations:
city: Lombard
country: United States
facility: National University of Health Sciences
state: Illinois
Study officials:
affiliation: National University of Health Sciences
name: Jerrilyn Cambron, DC, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cambron JA, Dexheimer JM, Duarte M, Freels S. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Sep;98(9):1752-1762. doi: 10.1016/j.apmr.2017.03.028. Epub 2017 Apr 30.