Clinical trial NCT06126887: Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
Official title: Evaluation of Efficacy and Comfort: A Randomized Clinical Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Back Pain
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female, age \> 18
* Has undergone treatment for an initial episode of nonspecific low back pain (LBP) lasting \> 1 month, with one of the following causative "Principle Diagnoses":
* Disc herniation
* Facet arthropathy
* Compression fracture
* Spondylolisthesis
* Sacroiliac joint dysfunction
* Scoliosis
* Mild to moderate central spinal stenosis
* Lumbar spondylosis
* Degenerative changes, not otherwise specified
* Utilize pain medication (including Step I or II analgesics, NSAIDs, Benzodiazepines) at least weekly for their LBP
* Subject report a VAS pain score at the time of consent greater than three (\>3) out of ten (10)
* Recommended a back brace for LBP management
* Provide written consent for participation
* Subject available for phone calls after 6PM

Exclusion Criteria:

* Severe central spinal stenosis
* Focal lower extremity weakness
* LBP radiating beyond the knee and/or accompanied by neurological signs (including sciatica)
* Spinal operation within 5 years preceding the study date
* Secondary LBP due to a work accident (e.g. workers comp)
* History of spinal arthrodesis
* LBP with an inflammatory, tumor, or infectious cause
* Contraindications to: Step I or II analgesics, NSAIDs, Benzodiazepines
* Diagnosed peripheral arterial disease
* Diabetes
* Higher functions do not enable proper comprehension of protocol or reliable data recording

Primary outcomes:
measure: User Evaluation of Satisfaction as assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)
timeFrame: 1 month
measure: Brace and sleeve utilization
timeFrame: 1 month
measure: Pain medication name
timeFrame: 1 month
measure: Functional disability status as assessed by the Oswestry Disability Index (ODI)
timeFrame: 1 month
measure: Pain as assessed by the Visual Analogue Scale (VAS)
timeFrame: 1 month
measure: Pain medication dosage used
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Johns Hopkins Health Care & Surgery Center - Howard County Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Akhil Chhatre, MD
role: PRINCIPAL_INVESTIGATOR
References: