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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-specific Low Back Pain
• Intervention / Treatment: Other: Leaderboard; Other: Take-home packet

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • READY Laboratory, Education Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leaderboard group; The group that has access to weekly leaderboards and on-demand videos.	Other: Leaderboard; De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group.
Active Comparator: Take-home packet group; The group that has access to paper take-home packets.	Other: Take-home packet; Take-home packet of exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): June 4, 2023
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 00004656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No