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Orthotic Use for Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT02089750
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 31, 2017
Sponsor:
Collaborators:
University of Illinois at Chicago
Foot Levelers, Inc.
Information provided by (Responsible Party):
Jerrilyn Cambron, DC, PhD, National University of Health Sciences

Tracking Information
First Submitted Date  ICMJE March 14, 2014
First Posted Date  ICMJE March 18, 2014
Last Update Posted Date March 31, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
  • 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.
  • 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."
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Orthotic Use for Chronic Low Back Pain
Official Title  ICMJE Orthotic Use for Chronic Low Back Pain: A Randomized Controlled Trial
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:

  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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • Other: Orthotics
  • Other: 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: Wait List
Study Arms  ICMJE
  • Active Comparator: Orthotics
    Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.
    Intervention: Other: Orthotics
  • Active Comparator: Orthotics Plus Chiropractic Care
    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.
    Interventions:
    • Other: Orthotics
    • Other: Orthotics Plus Chiropractic Care
  • Wait List
    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.
    Interventions:
    • Other: Orthotics
    • Other: Wait List
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 14, 2014)
225
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02089750
Other Study ID Numbers  ICMJE NUHS IRB_H-1203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jerrilyn Cambron, DC, PhD, National University of Health Sciences
Study Sponsor  ICMJE National University of Health Sciences
Collaborators  ICMJE
  • University of Illinois at Chicago
  • Foot Levelers, Inc.
Investigators  ICMJE
Principal Investigator: Jerrilyn Cambron, DC, MPH, PhD National University of Health Sciences
PRS Account National University of Health Sciences
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP