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Orthotic Use for Chronic Low Back Pain

CompletedNot applicableNCT02089750
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Orthotic Use for Chronic Low Back Pain: A Randomized Controlled Trial
Interventions
  • Other: Orthotics
  • Other: Orthotics Plus Chiropractic Care
  • Other: Wait List
Sponsor
National University of Health Sciences
Collaborators
University of Illinois at Chicago; Foot Levelers, Inc.
Start date
2014-03
Primary completion
2015-11
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02089750