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

Not Applicable

Active, not recruiting

• Conditions: Non-specific Low Back Pain
• Interventions: Other: Leaderboard; Other: Take-home packet

• Registration Number: NCT05573932
• Lead Sponsor: University of Central Florida

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.

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Study Start: 2022-10-13
• Primary Completion: 2023-06-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leaderboard group	Leaderboard	The group that has access to weekly leaderboards and on-demand videos.
Take-home packet group	Take-home packet	The group that has access to paper take-home packets.

Primary Outcome Measures

Name	Time	Method
Change in Disability	Change from baseline to 18 months	Assessed with the Oswestry Disability Index
Change in pain	Change from baseline to 18 months	Assessed by the numeric pain rating scale
Adherence	Change from baseline to 6 weeks	Assessed by the exercise adherence rating scale
Change in Muscle thickness of the lateral abdominal wall	Change from baseline to 6 weeks	Assessed with ultrasound during static positions and exercise starting positions

Trial Locations

Locations (1)

READY Laboratory, Education Complex; 🇺🇸 Orlando, Florida, United States