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

Non-specific Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05573932
• Other study ID #: 00004656
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: June 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Low Back Pain

Intervention

Other:
• Leaderboard
De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group.
• Take-home packet
Take-home packet of exercises.

Locations

Country	Name	City	State
United States	READY Laboratory, Education Complex	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	Assessed by the numeric pain rating scale	Change from baseline to 3 weeks
Primary	Change in pain	Assessed by the numeric pain rating scale	Change from baseline to 6 weeks
Primary	Change in pain	Assessed by the numeric pain rating scale	Change from baseline to 12 months
Primary	Change in pain	Assessed by the numeric pain rating scale	Change from baseline to 18 months
Primary	Change in Disability	Assessed with the Oswestry Disability Index	Change from baseline to 3 weeks
Primary	Change in Disability	Assessed with the Oswestry Disability Index	Change from baseline to 6 weeks
Primary	Change in Disability	Assessed with the Oswestry Disability Index	Change from baseline to 12 months
Primary	Change in Disability	Assessed with the Oswestry Disability Index	Change from baseline to 18 months
Primary	Adherence	Assessed by the exercise adherence rating scale	Change from baseline to 3 weeks
Primary	Adherence	Assessed by the exercise adherence rating scale	Change from baseline to 6 weeks
Primary	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