Orthotic Use for Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089750
• Other study ID #: NUHS IRB_H-1203
• Status: Completed
• Phase: N/A
• First received: March 14, 2014
• Last updated: March 30, 2017
• Start date: March 2014
• Est. completion date: November 2016

Study information

• Verified date: March 2017
• Source: National University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: November 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• 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).
• Wait List

Locations

Country	Name	City	State
United States	National University of Health Sciences	Lombard	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
National University of Health Sciences	Foot Levelers, Inc., University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale (NPRS)	The Numeric Pain Rating Scale (NPRS) is a numeric scale from 0-10, wherein patients can select (by circling or otherwise selecting) the one number along that line that best describes the pain being inquired about during the specified time period. The NPRS is one of the most frequently used methods for the measurement of clinical pain.	This primary outcome measure will be collected at the Randomization Visit and Week 6.
Primary	Modified Oswestry Disability Index (MODI)	The Modified Oswestry Disability Index, a condition specific questionnaire covering 10 areas of daily living and expressing the degree of disability as a percentage. The measured areas include: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment. Each category is scored on a continuum from 0 to 5 points, for a possible total score of 50 out of 50, popularly described as "100% disability."	This primary outcome measure will be collected at the Randomization Visit and Week 6.
Secondary	Numeric Pain Rating Scale (NPRS)		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.
Secondary	Modified Oswestry Disability Index (MODI)		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.