Gamified Rehabilitation for Low Back Pain

Overseen By Lauren C Mangum, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Central Florida

Must not be taking: Lidocaine patches, Prescription pain medicine

Disqualifiers: Lumbar spondylosis, Herniated disc, Spondylolisthesis, Previous spine surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help people with non-specific low back pain through exercise. Participants will use either a gamified rehab program (Gamified Rehab) featuring leaderboards and videos or a traditional paper-based rehab packet (Take-home Packet Rehab). The goal is to determine which method better reduces pain and disability over time. Suitable candidates have recently experienced low back pain or have had multiple episodes in the past few years. As an unphased trial, this study provides a unique opportunity for participants to explore innovative rehabilitation methods that could enhance their quality of life.

Do I have to stop taking my current medications for the trial?

Yes, you must stop using lidocaine patches or prescription pain medicine to participate in the trial.

What prior data suggests that this gamified rehabilitation protocol is safe for low back pain?

Research has shown that gamified rehabilitation is generally safe and well-received. For instance, one study on hand rehabilitation found that using games serves as a safe alternative to traditional physical therapy. Another study on virtual reality exercises, similar to gamified methods, demonstrated improvements in pain and movement without major safety concerns. Surveys indicate that gamified methods often lead to positive changes in muscle activity and heart rate, which are good indicators of safety.

No specific reports of negative effects from gamified rehabilitation for low back pain exist. However, using technology in rehabilitation has yielded promising results in managing pain and encouraging adherence to exercise routines, suggesting it is a safe option for many patients.

For the take-home exercise program, specific safety data is unavailable, but traditional exercise plans for low back pain are usually safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about gamified rehabilitation for low back pain because it introduces a fun and interactive approach to recovery, unlike traditional physical therapy. This method uses on-demand videos and leaderboards to engage patients, potentially increasing their motivation and adherence to the rehab program. Compared to standard take-home paper packets, this digital approach can offer real-time feedback and a more personalized rehabilitation experience. By making rehab more engaging, it could lead to better outcomes and a more enjoyable healing process for patients.

What evidence suggests that this trial's treatments could be effective for low back pain?

Research has shown that game-like activities in rehabilitation can reduce pain and improve the quality of life for individuals with muscle and joint problems. In this trial, participants in the "Leaderboard group" will engage in gamified rehab, featuring weekly leaderboards and on-demand videos. Studies have found that virtual reality exercises can significantly lessen pain, reduce disability, and increase movement for those with long-term low back pain. Meanwhile, the "Take-home packet group" will use paper take-home packets for rehabilitation. A review of research found that smartphone apps for rehabilitation noticeably decreased pain and disability. Additionally, doing rehab exercises at home with motion sensors and virtual reality has shown promise for managing pain and improving movement. Overall, gamified rehab offers a fun and effective way to manage low back pain. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-45 who have had low back pain in the last 6 months or at least three episodes of it in the past three years. It's not for those currently treated by rehab specialists, with specific back conditions like herniated discs, previous spine surgery, pregnancy, neurological symptoms, inability to exercise properly, or using certain pain medications.

Inclusion Criteria

I identify as either male or female.

I have experienced low back pain recently or multiple times in the past 3 years.

Exclusion Criteria

I do not have low back pain from conditions like herniated disc or previous spine surgery, and I am not pregnant.

I haven't seen a rehab specialist like a physical therapist in the last 6 months.

I cannot get into the starting position for exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 6-week exercise program with either a gamified experience or a take-home packet

6 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in pain, disability, and muscle thickness

18 months

Assessments at 3 weeks, 6 weeks, 12 months, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Gamified Rehab
• Take-home Packet Rehab

Trial Overview The study compares two ways to manage non-specific low back pain: a gamified rehab experience with leaderboards versus a traditional take-home packet. Participants will follow the same exercises and their progress will be tracked over time up to 18 months.

How Is the Trial Designed?

Group I: Leaderboard group Experimental Treatment 1 Intervention

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

Group II: Take-home packet group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

Published Research Related to This Trial

The 'Relieve my back' smartphone application significantly reduced pain intensity and disability in office workers with chronic low back pain after six weeks of use, compared to a control group that received a placebo version.

Participants using the application also experienced a notable improvement in their quality of life, as measured by the Short-Form Health Survey, indicating its potential as an effective management tool for low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an innovative smartphone application for office workers with chronic non-specific low back pain: a pilot randomized controlled trial. Almhdawi, KA., Obeidat, DS., Kanaan, SF., et al.[2022]

A systematic review of six studies involving 2100 participants found that smartphone apps can lead to a significant decrease in pain intensity and disability for adults managing low back pain, but results are inconsistent and not all studies showed benefits.

Current evidence is inconclusive regarding the effectiveness of smartphone apps for low back pain self-management without professional support, highlighting the need for further research and better regulation of app content to ensure alignment with evidence-based guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of smartphone apps for the self-management of low back pain in adults: a systematic review. Didyk, C., Lewis, LK., Lange, B.[2023]

The selfBACK app, designed for self-management of low back pain, was tested in a pilot study with 51 participants, showing a small but significant improvement in pain-related disability after 6 weeks of use, as measured by the Roland-Morris Disability Questionnaire (RMDQ).

Recruitment and screening procedures for the study were found to be feasible, with an acceptable ratio of participants screened to those enrolled, indicating that the methods could be effectively used in a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up. Sandal, LF., Øverås, CK., Nordstoga, AL., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9789284/

Gamification in Musculoskeletal Rehabilitation - PMC The exergame-based program was an effective intervention for reducing pain and increasing health-related quality of life. Afzal et al. [20•], 84 ...

2. rehab.jmir.org rehab.jmir.org/2023/1/e43985

Effects of Virtual Reality Exercises on Chronic Low Back Pain VR exercises had statistically significant effects on improving pain, low back disability, and range of motion in all groups.

3. withpower.com withpower.com/trial/phase-low-back-pain-9-2022-81219

Gamified Rehabilitation for Low Back Pain A systematic review of six studies involving 2100 participants found that smartphone apps can lead to a significant decrease in pain intensity and disability ...

4. mdpi.com mdpi.com/2227-7080/13/5/186

Remote Rehabilitation and Virtual Reality Interventions ... Motion sensor-based remote rehabilitation and VR interventions show promising results in pain management, mobility, and adherence for individuals with CLBP.

5. tandfonline.com tandfonline.com/doi/abs/10.1080/09638288.2024.2368694

Gamified delivery of at-home rehabilitation for individuals ... To measure the change in pain and disability during and after a 6-week gamified delivery of home exercise compared to a take-home packet.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714418302088

Virtual immersive gaming to optimize recovery (VIGOR) in ... In a survey, it is found that the muscle activities and heart rate of the patient in rehabilitation process increase positively in gamified methods as compared ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38899776/

Gamified delivery of at-home rehabilitation for individuals ... Core exercises completed until failure may improve disability and pain at 6-weeks and positively influence perceived patient improvement.