NCT02089750

Orthotic Use for Chronic Low Back Pain

Orthotic Use for Chronic Low Back Pain: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: National University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
OTHER	Orthotics
OTHER	Orthotics Plus Chiropractic Care	The six week Chiropractic Care portion of this intervention may include the use of ice packs, hot packs, massage, and chiropractic manipulations to the spine or lower extremities (utilizing High Velocity Low Amplitude and/or Flexion Distraction manipulations).
OTHER	Wait List

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-11-01
• Completion: 2016-11-01
• First posted: 2014-03-18
• Last updated: 2017-03-31

Locations

1 site across 1 country: United States