Overview

This trial is active, not recruiting.

Condition chronic low back pain
Treatments orthotics, orthotics plus chiropractic care, wait list
Sponsor National University of Health Sciences
Collaborator University of Illinois at Chicago
Start date March 2014
End date November 2015
Trial size 225 participants
Trial identifier NCT02089750, NUHS IRB_H-1203

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.
orthotics
(Active Comparator)
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.
orthotics
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)
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.
orthotics
wait list

Primary Outcomes

Measure
Numeric Pain Rating Scale (NPRS)
time frame: This primary outcome measure will be collected at the Randomization Visit and Week 6.
Modified Oswestry Disability Index (MODI)
time frame: This primary outcome measure will be collected at the Randomization Visit and Week 6.

Secondary Outcomes

Measure
Numeric Pain Rating Scale (NPRS)
time frame: 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.
Modified Oswestry Disability Index (MODI)
time frame: 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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Orthotic Use for Chronic Low Back Pain: A Randomized Controlled Trial
Principal investigator Jerrilyn Cambron, DC, MPH, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by National University of Health Sciences.