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Orthotic Use for Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Orthotics

Orthotics Plus Chiropractic Care

Wait List

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Low Back Pain, Chiropractic, Shoe Orthotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least 18 years old
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
Symptoms must have been present for at least three months

Exclusion Criteria:

Use of custom-made orthotics in the past 6 months
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).
Current or future litigation for any healthcare concern
Not fluent or literate in the English language. We will not be able to provide multiple translators within this study
Brain disorders (e.g., dementia, Alzheimers Disease , etc.) that would lead to difficulty in questionnaire completion
Chronic pain other than low back pain, such as fibromyalgia or multiple sclerosis
Clinically significant chronic inflammatory spinal arthritis
Spinal pathology or fracture
Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome
History of bleeding disorder
Known arterial aneurysm
Previous lumbar spine surgery
Severe skeletal deformity of the foot
Peripheral neuropathy due to disorders such as diabetes
Low back pain that is not reproducible
Current pregnancy
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

Sites / Locations

National University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Arm Label

Orthotics

Orthotics Plus Chiropractic Care

Wait List

Arm Description

Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.

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.

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.

Outcomes

Primary Outcome Measures

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.

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."

Secondary Outcome Measures

Numeric Pain Rating Scale (NPRS)

Modified Oswestry Disability Index (MODI)

Full Information

NCT ID

NCT02089750

First Posted

March 14, 2014

Last Updated

March 30, 2017

Sponsor

National University of Health Sciences

Collaborators

University of Illinois at Chicago, Foot Levelers, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02089750

Brief Title

Orthotic Use for Chronic Low Back Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Health Sciences

Collaborators

University of Illinois at Chicago, Foot Levelers, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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. 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. To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12 months following the 12 week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

Low Back Pain, Chiropractic, Shoe Orthotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Orthotics

Arm Type

Active Comparator

Arm Description

Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.

Arm Title

Orthotics Plus Chiropractic Care

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Wait List

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Orthotics

Intervention Type

Other

Intervention Name(s)

Orthotics Plus Chiropractic Care

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Wait List

Primary Outcome Measure Information:

Title

Numeric Pain Rating Scale (NPRS)

Description

Time Frame

This primary outcome measure will be collected at the Randomization Visit and Week 6.

Title

Modified Oswestry Disability Index (MODI)

Description

Time Frame

This primary outcome measure will be collected at the Randomization Visit and Week 6.

Secondary Outcome Measure Information:

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 18 years old 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 Symptoms must have been present for at least three months Exclusion Criteria: Use of custom-made orthotics in the past 6 months 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). Current or future litigation for any healthcare concern Not fluent or literate in the English language. We will not be able to provide multiple translators within this study Brain disorders (e.g., dementia, Alzheimers Disease , etc.) that would lead to difficulty in questionnaire completion Chronic pain other than low back pain, such as fibromyalgia or multiple sclerosis Clinically significant chronic inflammatory spinal arthritis Spinal pathology or fracture Progressive neurologic deficits due to nerve root or spinal cord compression, including symptoms/signs of cauda equina syndrome History of bleeding disorder Known arterial aneurysm Previous lumbar spine surgery Severe skeletal deformity of the foot Peripheral neuropathy due to disorders such as diabetes Low back pain that is not reproducible Current pregnancy 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerrilyn Cambron, DC, MPH, PhD

Organizational Affiliation

National University of Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University of Health Sciences

City

Lombard

State/Province

Illinois

ZIP/Postal Code

60148

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28465224

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.

Results Reference

derived

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Orthotic Use for Chronic Low Back Pain

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