40 Participants Needed
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Gamified Rehabilitation for Low Back Pain

LC
Overseen ByLauren C Mangum, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Gamified Rehab, Take-home Packet Rehab for low back pain?

Research shows that using video game technology and virtual reality for exercise can help people stick to their home exercise routines and manage their low back pain better. These gamified approaches have been found to reduce pain intensity and improve enjoyment and adherence to exercise programs.12345

Is gamified rehabilitation for low back pain safe for humans?

The studies on gamified rehabilitation for low back pain, including virtual reality interventions, do not report any specific safety concerns, suggesting it is generally safe for human use.23678

How is the Gamified Rehabilitation treatment for low back pain different from other treatments?

Gamified Rehabilitation for low back pain is unique because it uses game-like elements to make exercises more engaging, which can improve adherence and enjoyment, potentially leading to better outcomes compared to traditional exercise programs.123910

What is the purpose of this trial?

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.

Eligibility Criteria

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.
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Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Leaderboard groupExperimental Treatment1 Intervention
The group that has access to weekly leaderboards and on-demand videos.
Group II: Take-home packet groupActive Control1 Intervention
The group that has access to paper take-home packets.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials
101
Recruited
1,191,000+

Findings from Research

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.
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]
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.
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 '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.
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]

References

Video-Game-Based Exercises for Older People With Chronic Low Back Pain: A Randomized Controlledtable Trial (GAMEBACK). [2022]
Get Your Head in the Game: A Replicated Single-Case Experimental Design Evaluating the Effect of a Novel Virtual Reality Intervention in People With Chronic Low Back Pain. [2023]
A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up. [2022]
Effectiveness of smartphone apps for the self-management of low back pain in adults: a systematic review. [2023]
Efficacy of an innovative smartphone application for office workers with chronic non-specific low back pain: a pilot randomized controlled trial. [2022]
Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial. [2019]
Assessment of the Quality of Mobile Applications (Apps) for Management of Low Back Pain Using the Mobile App Rating Scale (MARS). [2021]
Completeness of Outcomes Description Reported in Low Back Pain Rehabilitation Interventions: A Survey of 185 Randomized Trials. [2019]
Gamification in Therapeutic Rehabilitation of Distal Radial and Ulnar Fracture: A Case Report. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
TEXT4myBACK: A Text Message Intervention to Improve Function in People With Low Back Pain-Protocol of a Randomized Controlled Trial. [2021]
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