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
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Other: Orthotics Other: Orthotics Plus Chiropractic Care Other: Wait List||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Orthotic Use for Chronic Low Back Pain: A Randomized Controlled Trial|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2016|
Active Comparator: Orthotics
Subjects are asked to wear custom-made shoe orthotics for a 12 week study period.
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.
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).
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: Wait List
- 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."
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089750
|United States, Illinois|
|National University of Health Sciences|
|Lombard, Illinois, United States, 60148|
|Principal Investigator:||Jerrilyn Cambron, DC, MPH, PhD||National University of Health Sciences|