Clinical trial NCT05573932: Gamified Rehab vs Take-home Packet Rehab for Non-specific Low Back Pain
Official title: The Effects of a Gamified Rehabilitation Protocol Compared to an At-Home Exercise Packet in Individuals With Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-specific Low Back Pain
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain
timeFrame: Change from baseline to 3 weeks
measure: Change in pain
timeFrame: Change from baseline to 6 weeks
measure: Change in pain
timeFrame: Change from baseline to 12 months
measure: Change in pain
timeFrame: Change from baseline to 18 months
measure: Change in Disability
timeFrame: Change from baseline to 3 weeks
measure: Change in Disability
timeFrame: Change from baseline to 6 weeks
measure: Change in Disability
timeFrame: Change from baseline to 12 months
measure: Change in Disability
timeFrame: Change from baseline to 18 months
measure: Adherence
timeFrame: Change from baseline to 3 weeks
measure: Adherence
timeFrame: Change from baseline to 6 weeks
measure: Change in Muscle thickness of the lateral abdominal wall
timeFrame: Change from baseline to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: READY Laboratory, Education Complex
state: Florida
Study officials:
References: