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Completed

NCT Number: NCT02089750

Orthotic Use for Chronic Low Back Pain

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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University of Health Sciences

Lombard, Illinois, 60148, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthotics

Other

Orthotics Plus Chiropractic Care

Other

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

Other

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

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

    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.

  2. Modified Oswestry Disability Index (MODI)

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

    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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

National University of Health Sciences

Other

Collaborators

  • Foot Levelers, Inc.
  • University of Illinois at Chicago

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 18, 2014
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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