Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients
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|ClinicalTrials.gov Identifier: NCT03478007|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : November 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Device: Intervention Technology Device: Intervention Technology Plus Coaching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients|
|Actual Study Start Date :||August 21, 2019|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
No Intervention: Usual Treatment
Usual standard of care (exercises)
Experimental: Intervention Technology Only
Exercises with technology alone
Device: Intervention Technology
Subjects will perform their exercises using the provided monitoring device. They will be able to contact the investigators with questions regarding the use of the monitoring device, however, no encouragement or coaching will be provided
Experimental: Intervention Technology Plus Coaching
Exercises with technology plus coaching
Device: Intervention Technology Plus Coaching
Subjects will perform their exercises using the provided monitoring device. They will also be coached by a trained health coach through a weekly call.
- Change in Back Disability Related Quality of Life [ Time Frame: Baseline and 8 weeks ]Participants will fill out the Modified Oswestry Disability Index, a 10 section questionnaire with 6 possible answers within each section. Statement 1 is graded as 0 points; statement 6 is graded as 5 points. A total score of 50 is possible and would indicate 100% disability. A score of 0-20% indicates minimal disability.
- Change in Overall Pain [ Time Frame: Baseline and 8 weeks ]Participants will fill out the pain Numerical Rating Scale survey, a 4 question survey used to rate intensity of pain from a scale of 0 ("no pain") to 10 ("worst possible pain"). Pain is categorized as mile (1-3), moderate (4-6) or severe (7-10).
- Degree of Compliance [ Time Frame: 4 and 8 weeks ]Compliance collected through written diaries (control group) or electronically recorded compliance monitoring. Compliance will be defined on whether or not the subject completed the assigned exercises each day.
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): NCT03478007
|Contact: Stacy Loushin, BSemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Kenton R Kaufman, Ph.D||Mayo Clinic|