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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incrediwear Daytime | Experimental | Incrediwear back brace worn 7AM-7PM (against skin) |
|
| Incrediwear Sham Daytime | Sham Comparator | Incrediwear sham back brace worn 7AM-7PM (against skin) |
|
| Control Daytime | Placebo Comparator | Standard-issue brace (e.g. Horizon Lumbar Brace (Aspen Medical Products, LLC)) worn 7AM-7PM |
|
| Incrediwear 24 hour | Active Comparator | Incrediwear back brace worn 7AM-7PM (against skin). Incrediwear waist sleeve worn 7PM-7AM (against skin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incrediwear Daytime Back Brace | Device | Incrediwear Daytime Back Brace |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Brace and sleeve utilization | Self-reported hours worn | 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 | 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) | 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 | 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 | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akhil Chhatre, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Health Care & Surgery Center - Howard County Medical Center | Columbia | Maryland | 21044 | United States |
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| Incrediwear Sham Daytime Back Brace |
| Device |
Incrediwear Sham Daytime Back Brace |
|
| Control Daytime Back Brace | Device | Control Daytime Back Brace |
|
| Incrediwear 24 Hour Back Brace | Device | Incrediwear 24 Hour Back Brace |
|
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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