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

NCT ID: NCT05573932

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-13

Study Completion Date

2025-06-30

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.

Conditions

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Non-specific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Leaderboard group

The group that has access to weekly leaderboards and on-demand videos.

Group Type EXPERIMENTAL

Leaderboard

Intervention Type OTHER

De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group.

Take-home packet group

The group that has access to paper take-home packets.

Group Type ACTIVE_COMPARATOR

Take-home packet

Intervention Type OTHER

Take-home packet of exercises.

Interventions

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Leaderboard

De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group.

Intervention Type OTHER

Take-home packet

Take-home packet of exercises.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Central Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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READY Laboratory, Education Complex

Orlando, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38899776 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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00004656

Identifier Type: -

Identifier Source: org_study_id