Gamified Rehab vs Take-home Packet Rehab for Non-specific Low Back Pain

Study Overview
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Brief Summary
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Two groups with non-specific low back pain will be completing the same exercise protocol. The leaderboard group will have a gamified experience and the take-home packet group will be using a paper take-home packet. Outcomes will be measured at 3 weeks, 6 weeks, with pain and disability also being measured at 12 and 18 months.

Detailed Description
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There will be two groups in this study, the leaderboard group, and the take-home packet group. The leaderboard group and the take-home packet group will be completing the same exercise program throughout the 6-weeks. The exercises included the plank, side plank (left and right side), foot elevated (left and right side), dead bug and bird dog exercise until discontinuation. The exercises will increase with repetitions every two weeks and that outline is listed below in procedures involved. The leaderboard group will have on demand video access to the exercises and the take-home packet group will have a take-home packet. The leaderboard group will also be receiving weekly leaderboards of average and top exercise durations of the leaderboard group participants. The audio description of exercise in the on-demand video group is the same script as the written description in the take-home packet.

Official Title
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The Effects of a Gamified Rehabilitation Protocol Compared to an At-Home Exercise Packet in Individuals With Low Back Pain

Conditions
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Non-specific Low Back Pain

Intervention / Treatment
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* Other: Leaderboard
* Other: Take-home packet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18-45 years old Biological sex of Male or Female Self-reported low back pain within the previous 6 months or greater than 3 episodes within the past 3 years Exclusion Criteria: Must not be currently seeing and or receiving care from an athletic trainer, physical therapist, or other rehabilitation specialist in the previous 6 months Must not have low back pain conditions such as lumbar spondylosis, herniated disc, spondylolisthesis, previous spine surgery, currently pregnant, experiencing neurological symptoms or other muscular abnormalities Unable to assume the exercise starting position Current use of lidocaine patches or prescription pain medicine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leaderboard group<br>The group that has access to weekly leaderboards and on-demand videos. | Other: Leaderboard<br>* De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group.<br>|
| Active Comparator: Take-home packet group<br>The group that has access to paper take-home packets. | Other: Take-home packet<br>* Take-home packet of exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Assessed by the numeric pain rating scale | Change from baseline to 3 weeks | 
| Change in pain | Assessed by the numeric pain rating scale | Change from baseline to 6 weeks | 
| Change in pain | Assessed by the numeric pain rating scale | Change from baseline to 12 months | 
| Change in pain | Assessed by the numeric pain rating scale | Change from baseline to 18 months | 
| Change in Disability | Assessed with the Oswestry Disability Index | Change from baseline to 3 weeks | 
| Change in Disability | Assessed with the Oswestry Disability Index | Change from baseline to 6 weeks | 
| Change in Disability | Assessed with the Oswestry Disability Index | Change from baseline to 12 months | 
| Change in Disability | Assessed with the Oswestry Disability Index | Change from baseline to 18 months | 
| Adherence | Assessed by the exercise adherence rating scale | Change from baseline to 3 weeks | 
| Adherence | Assessed by the exercise adherence rating scale | Change from baseline to 6 weeks | 
| Change in Muscle thickness of the lateral abdominal wall | Assessed with ultrasound during static positions and exercise starting positions | Change from baseline to 6 weeks |