Non-specific Low Back PainNCT05573932
Gamified Rehab vs Take-home Packet Rehab for Non-specific Low Back Pain
A study testing Leaderboard and Take-home packet in people with Non-specific Low Back Pain, run by University of Central Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- Leaderboard and Take-home packet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
READY Laboratory, Education Complex
Orlando, Florida, 32816
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-specific Low Back Pain
- Being tested
- Leaderboard, Take-home packet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeaderboardOther
De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group.
Take-home packetOther
Take-home packet of exercises.
| Study group | Role | What they receive |
|---|---|---|
| Leaderboard group | Experimental | The group that has access to weekly leaderboards and on-demand videos. Receives: Other: Leaderboard |
| Take-home packet group | Active comparator | The group that has access to paper take-home packets. Receives: Other: Take-home packet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Assessed by the numeric pain rating scale
Measured: Change from baseline to 3 weeks
Change in pain
Assessed by the numeric pain rating scale
Measured: Change from baseline to 6 weeks
Change in pain
Assessed by the numeric pain rating scale
Measured: Change from baseline to 12 months
Change in pain
Assessed by the numeric pain rating scale
Measured: Change from baseline to 18 months
Change in Disability
Assessed with the Oswestry Disability Index
Measured: Change from baseline to 3 weeks
Change in Disability
Assessed with the Oswestry Disability Index
Measured: Change from baseline to 6 weeks
Change in Disability
Assessed with the Oswestry Disability Index
Measured: Change from baseline to 12 months
Change in Disability
Assessed with the Oswestry Disability Index
Measured: Change from baseline to 18 months
Adherence
Assessed by the exercise adherence rating scale
Measured: Change from baseline to 3 weeks
Adherence
Assessed by the exercise adherence rating scale
Measured: 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
Measured: Change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start13 Oct 2022
- Primary completion4 Jun 2023
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573932
- Sponsor's protocol ID
- 00004656
- Status last verified
- Nov 2023
- First submitted
- 26 Sep 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devorski L, Suppiah A, Fukuda DH, Stout J, Ingersoll CD, Mangum LC. Gamified delivery of at-home rehabilitation for individuals with nonspecific low back pain: a randomized controlled trial. Disabil Rehabil. 2025 Mar;47(6):1416-1422. doi: 10.1080/09638288.2024.2368694. Epub 2024 Jun 20.
PubMed 38899776
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Gamified Rehabilitation Protocol Compared to an At-Home Exercise Packet in Individuals With Low Back Pain
- ClinicalTrials.gov ID
- NCT05573932
- Acronym / sponsor ID
- 00004656
- Conditions
- Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leaderboard group | Experimental | Other: LeaderboardThe group that has access to weekly leaderboards and on-demand videos. |
| Take-home packet group | Active comparator | Other: Take-home packetThe group that has access to paper take-home packets. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeaderboardDe-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group. | Other | Leaderboard group |
| Take-home packetTake-home packet of exercises. | Other | Take-home packet group |
Primary outcome
Change in pain
Time frame: Change from baseline to 3 weeks
Assessed by the numeric pain rating scale
Change in pain
Time frame: Change from baseline to 6 weeks
Assessed by the numeric pain rating scale
Change in pain
Time frame: Change from baseline to 12 months
Assessed by the numeric pain rating scale
Change in pain
Time frame: Change from baseline to 18 months
Assessed by the numeric pain rating scale
Change in Disability
Time frame: Change from baseline to 3 weeks
Assessed with the Oswestry Disability Index
Change in Disability
Time frame: Change from baseline to 6 weeks
Assessed with the Oswestry Disability Index
Change in Disability
Time frame: Change from baseline to 12 months
Assessed with the Oswestry Disability Index
Change in Disability
Time frame: Change from baseline to 18 months
Assessed with the Oswestry Disability Index
Adherence
Time frame: Change from baseline to 3 weeks
Assessed by the exercise adherence rating scale
Adherence
Time frame: Change from baseline to 6 weeks
Assessed by the exercise adherence rating scale
Change in Muscle thickness of the lateral abdominal wall
Time frame: Change from baseline to 6 weeks
Assessed with ultrasound during static positions and exercise starting positions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 38899776Devorski L, Suppiah A, Fukuda DH, Stout J, Ingersoll CD, Mangum LC. Gamified delivery of at-home rehabilitation for individuals with nonspecific low back pain: a randomized controlled trial. Disabil Rehabil. 2025 Mar;47(6):1416-1422. doi: 10.1080/09638288.2024.2368694. Epub 2024 Jun 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leaderboard and Take-home packet in people with Non-specific Low Back Pain, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain (time frame: Change from baseline to 3 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.