NCT05573932

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

October 13, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

September 26, 2022

Last Update Submit

November 27, 2023

Conditions

Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (2)

Leaderboard group

EXPERIMENTAL

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

Other: Leaderboard

Take-home packet group

ACTIVE COMPARATOR

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

Other: Take-home packet

Interventions

LeaderboardOTHER

De-identified leaderboard showing average durations of exercises completed by all participants in leaderboard group.

Leaderboard group
Take-home packetOTHER

Take-home packet of exercises.

Take-home packet group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

READY Laboratory, Education Complex

Orlando, Florida, 32816, United States

Location

Related Publications (1)

  • 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.

    PMID: 38899776DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 10, 2022

Study Start

October 13, 2022

Primary Completion

June 4, 2023

Study Completion

June 1, 2025

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)