Low Back PainNCT06126887
Evaluation of Efficacy and Comfort: A Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
A study testing Incrediwear Daytime Back Brace and Incrediwear 24 Hour Back Brace in people with Low Back Pain and Back Pain, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Back Pain
- What is being tested?
- Incrediwear Daytime Back Brace and Incrediwear 24 Hour Back Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Health Care & Surgery Center - Howard County Medical Center
Columbia, Maryland, 21044
About this study
Official title: Evaluation of Efficacy and Comfort: A Randomized Clinical Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
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.
Read the 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.
- Conditions
- Low Back Pain, Back Pain
- Being tested
- Incrediwear Daytime Back Brace, Incrediwear Sham Daytime Back Brace, Control Daytime Back Brace, Incrediwear 24 Hour Back Brace
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incrediwear Daytime Back BraceDevice
Incrediwear Daytime Back Brace
Incrediwear Sham Daytime Back BraceDevice
Incrediwear Sham Daytime Back Brace
Control Daytime Back BraceDevice
Control Daytime Back Brace
Incrediwear 24 Hour Back BraceDevice
Incrediwear 24 Hour Back Brace
| Study group | Role | What they receive |
|---|---|---|
| Incrediwear Daytime | Experimental | Incrediwear back brace worn 7AM-7PM (against skin) Receives: Device: Incrediwear Daytime Back Brace |
| Incrediwear Sham Daytime | Sham comparator | Incrediwear sham back brace worn 7AM-7PM (against skin) Receives: Device: Incrediwear Sham Daytime Back Brace |
| Control Daytime | Placebo comparator | Standard-issue brace (e.g. Horizon Lumbar Brace (Aspen Medical Products, LLC)) worn 7AM-7PM Receives: Device: Control Daytime Back Brace |
| Incrediwear 24 hour | Active comparator | Incrediwear back brace worn 7AM-7PM (against skin). Incrediwear waist sleeve worn 7PM-7AM (against skin) Receives: Device: Incrediwear 24 Hour Back Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Brace and sleeve utilization
Self-reported hours worn
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start9 Jan 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akhil Chhatre, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126887
- Sponsor's protocol ID
- IRB00391930
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Comfort: A Randomized Clinical Trial on the Incrediwear Back Brace in Patients With Chronic Lower Back Pain
- ClinicalTrials.gov ID
- NCT06126887
- Acronym / sponsor ID
- IRB00391930
- Conditions
- Low Back Pain, Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Incrediwear Daytime | Experimental | Device: Incrediwear Daytime Back BraceIncrediwear back brace worn 7AM-7PM (against skin) |
| Incrediwear Sham Daytime | Sham comparator | Device: Incrediwear Sham Daytime Back BraceIncrediwear sham back brace worn 7AM-7PM (against skin) |
| Control Daytime | Placebo comparator | Device: Control Daytime Back BraceStandard-issue brace (e.g. Horizon Lumbar Brace (Aspen Medical Products, LLC)) worn 7AM-7PM |
| Incrediwear 24 hour | Active comparator | Device: Incrediwear 24 Hour Back BraceIncrediwear back brace worn 7AM-7PM (against skin). Incrediwear waist sleeve worn 7PM-7AM (against skin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incrediwear Daytime Back BraceIncrediwear Daytime Back Brace | Device | Incrediwear Daytime |
| Incrediwear Sham Daytime Back BraceIncrediwear Sham Daytime Back Brace | Device | Incrediwear Sham Daytime |
| Control Daytime Back BraceControl Daytime Back Brace | Device | Control Daytime |
| Incrediwear 24 Hour Back BraceIncrediwear 24 Hour Back Brace | Device | Incrediwear 24 hour |
Primary outcome
User Evaluation of Satisfaction as assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)
Time frame: 1 month
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
Brace and sleeve utilization
Time frame: 1 month
Self-reported hours worn
Pain medication name
Time frame: 1 month
The investigators aim to explore the effects of brace utilization on pain medication use. The investigators will document the pain medication name
Functional disability status as assessed by the Oswestry Disability Index (ODI)
Time frame: 1 month
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)
Pain as assessed by the Visual Analogue Scale (VAS)
Time frame: 1 month
Visual Analogue Scale (VAS) and frequency (ordinal scale). 0 = no pain and 10 = pain as bad as it could possibly be
Pain medication dosage used
Time frame: 1 month
The investigators aim to explore the effects of brace utilization on pain medication use. The investigators will document the pain medication dosage used
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akhil Chhatre, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incrediwear Daytime Back Brace and Incrediwear 24 Hour Back Brace in people with Low Back Pain and Back Pain, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Evaluation of Satisfaction as assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0) (time frame: 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.