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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leaderboard group | Experimental | The group that has access to weekly leaderboards and on-demand videos. |
|
| Take-home packet group | Active Comparator | The group that has access to paper take-home packets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leaderboard | Other | De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| READY Laboratory, Education Complex | Orlando | Florida | 32816 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38899776 | Derived | Devorski L, Suppiah A, Fukuda DH, Stout J, Ingersoll CD, Mangum LC. Gamified delivery of at-home rehabilitation for individuals with nonspecific low back pain: a randomized controlled trial. Disabil Rehabil. 2025 Mar;47(6):1416-1422. doi: 10.1080/09638288.2024.2368694. Epub 2024 Jun 20. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 24, 2025 | |
| Reset | Apr 10, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2022 | Sep 28, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 9, 2022 | Sep 28, 2022 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2025 | Apr 10, 2025 |
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Participants will be randomized into the two separate groups using a random number generator and allocation will be concealed in opaque envelopes prior to data collection.
| Take-home packet | Other | Take-home packet of exercises. |
|
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 |