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

Primary Purpose

Non-specific Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leaderboard
Take-home packet
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Low Back Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • READY Laboratory, Education ComplexRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Leaderboard group

Take-home packet group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in pain
Assessed by the numeric pain rating scale
Change in pain
Assessed by the numeric pain rating scale
Change in pain
Assessed by the numeric pain rating scale
Change in pain
Assessed by the numeric pain rating scale
Change in Disability
Assessed with the Oswestry Disability Index
Change in Disability
Assessed with the Oswestry Disability Index
Change in Disability
Assessed with the Oswestry Disability Index
Change in Disability
Assessed with the Oswestry Disability Index
Adherence
Assessed by the exercise adherence rating scale
Adherence
Assessed by the exercise adherence rating scale
Change in Muscle thickness of the lateral abdominal wall
Assessed with ultrasound during static positions and exercise starting positions

Secondary Outcome Measures

Full Information

First Posted
September 26, 2022
Last Updated
October 14, 2022
Sponsor
University of Central Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05573932
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Central Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Leaderboard group
Arm Type
Experimental
Arm Description
The group that has access to weekly leaderboards and on-demand videos.
Arm Title
Take-home packet group
Arm Type
Active Comparator
Arm Description
The group that has access to paper take-home packets.
Intervention Type
Other
Intervention Name(s)
Leaderboard
Intervention Description
De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group.
Intervention Type
Other
Intervention Name(s)
Take-home packet
Intervention Description
Take-home packet of exercises.
Primary Outcome Measure Information:
Title
Change in pain
Description
Assessed by the numeric pain rating scale
Time Frame
Change from baseline to 3 weeks
Title
Change in pain
Description
Assessed by the numeric pain rating scale
Time Frame
Change from baseline to 6 weeks
Title
Change in pain
Description
Assessed by the numeric pain rating scale
Time Frame
Change from baseline to 12 months
Title
Change in pain
Description
Assessed by the numeric pain rating scale
Time Frame
Change from baseline to 18 months
Title
Change in Disability
Description
Assessed with the Oswestry Disability Index
Time Frame
Change from baseline to 3 weeks
Title
Change in Disability
Description
Assessed with the Oswestry Disability Index
Time Frame
Change from baseline to 6 weeks
Title
Change in Disability
Description
Assessed with the Oswestry Disability Index
Time Frame
Change from baseline to 12 months
Title
Change in Disability
Description
Assessed with the Oswestry Disability Index
Time Frame
Change from baseline to 18 months
Title
Adherence
Description
Assessed by the exercise adherence rating scale
Time Frame
Change from baseline to 3 weeks
Title
Adherence
Description
Assessed by the exercise adherence rating scale
Time Frame
Change from baseline to 6 weeks
Title
Change in Muscle thickness of the lateral abdominal wall
Description
Assessed with ultrasound during static positions and exercise starting positions
Time Frame
Change from baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren C Mangum, PhD
Phone
4078232795
Email
lauren.mangum@ucf.edu
Facility Information:
Facility Name
READY Laboratory, Education Complex
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren C Mangum, PhD, ATC
Phone
407-823-2795
Email
lauren.mangum@ucf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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