Orthotic Use for Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Orthotics
* Other: Orthotics Plus Chiropractic Care
* Other: Wait List


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Orthotics<br>Subjects are asked to wear custom-made shoe orthotics for a 12 week study period. | Other: Orthotics<br> <br> |
| Active Comparator: Orthotics Plus Chiropractic Care<br>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. | Other: Orthotics<br> <br> Other: Orthotics Plus Chiropractic Care<br>* 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).<br>|
| Other: Wait List<br>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. | Other: Orthotics<br> <br> Other: Wait List<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Chiropractic, Shoe Orthotics