An interventional study of Incrediwear Daytime Back Brace and Incrediwear Sham Daytime Back Brace in Low Back Pain and Back Pain, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Supportive care
The investigators hypothesize that the utilization of Incrediwear's Back Brace, compared to a sham brace and a standard-issue brace, will lead to better brace adherence, increased patient satisfaction, reduced pain medication usage, and improved functional disability among non-surgical chronic LBP patients.
Problem: Chronic low back pain (LBP) affects a substantial portion of the population and often leads to decreased functional ability and increased pain medication usage. While back braces have been recommended as part of LBP management, their efficacy and impact on patient outcomes remain uncertain.
Research Hypothesis: The investigators hypothesize that the utilization of Incrediwear's Back Brace, compared to a sham brace and a standard-issue brace, will lead to better brace adherence, increased patient satisfaction, reduced pain medication usage, and improved functional disability among non-surgical chronic LBP patients.
Importance of the Research: This randomized clinical trial aims to assess the efficacy of Incrediwear's Back Brace in improving patient outcomes for chronic LBP. The study will provide valuable insights into the utilization patterns and adherence of back braces, patient satisfaction with treatment protocols, and the impact of brace usage on pain medication consumption and functional disability. By evaluating these factors through a controlled trial, the investigators seek to enhance the understanding of effective LBP management strategies, potentially reducing the burden of chronic LBP on patients and healthcare systems.
The study will be conducted under the guidance of Dr. Akhil Chhatre, Principal Investigator at the Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine. The research will involve 100 non-surgical chronic LBP patients meeting specific inclusion criteria. The patients will be randomly assigned to one of four study groups, and data will be collected through phone calls over a full 4-week duration.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Incrediwear back brace worn 7AM-7PM (against skin)
Device: Incrediwear Daytime Back Brace
Incrediwear sham back brace worn 7AM-7PM (against skin)
Device: Incrediwear Sham Daytime Back Brace
Standard-issue brace (e.g. Horizon Lumbar Brace (Aspen Medical Products, LLC)) worn 7AM-7PM
Device: Control Daytime Back Brace
Incrediwear back brace worn 7AM-7PM (against skin). Incrediwear waist sleeve worn 7PM-7AM (against skin)
Device: Incrediwear 24 Hour Back Brace
Incrediwear Daytime Back Brace
Incrediwear Sham Daytime Back Brace
Control Daytime Back Brace
Incrediwear 24 Hour Back Brace
User Evaluation of Satisfaction as assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)
Satisfaction (Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 \[QUEST 2.0\] score). The score ranges from 1-5 with 1 being not satisfied at all to 5 being very satisfied
Time frame: 1 month
Brace and sleeve utilization
Self-reported hours worn
Time frame: 1 month
Pain medication name
The investigators aim to explore the effects of brace utilization on pain medication use. The investigators will document the pain medication name
Time frame: 1 month
Functional disability status as assessed by the Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI). A total score of 0-4 (no disability), 5-14 (mild disability), 15-24 (moderate disability), 25-34 (severe disability), 35-50 (completely disabled)
Time frame: 1 month
Pain as assessed by the Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) and frequency (ordinal scale). 0 = no pain and 10 = pain as bad as it could possibly be
Time frame: 1 month
Pain medication dosage used
The investigators aim to explore the effects of brace utilization on pain medication use. The investigators will document the pain medication dosage used
Time frame: 1 month
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Nov 2024, 10 months.
Of 1,187 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 10 months is close to that.
Counting every sponsor, half of 1,246 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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