Lower Back PainNCT06749912
Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
A study testing Low back pain wrap in people with Lower Back Pain and Lower Back Pain Chronic, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The goal of this counterbalanced cross-over study is to determine whether a recovery lumbar wrap effectively reduces lower back pain and improves outcomes related to physical function and quality of life in adults with LBP in adults 20-65 years old. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Lower Back Pain, Lower Back Pain Chronic, Acute Low Back Pain
- What is being tested?
- Low back pain wrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 23 May 2025
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 - 65
- Males and Females (50-50 split or close)
- Range of ethnicities
- Range of BMIs
Who cannot join
- Those with diagnosed cancer, infection, trauma, or LBP requiring surgical intervention
- Those currently undergoing rehabilitation treatment for LBP
- Those with other diagnosed conditions that may preclude them from safely participating
- Pregnant women
- Waist less than 26" or greater than 66" due to device limitations
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this counterbalanced cross-over study is to determine whether a recovery lumbar wrap effectively reduces lower back pain and improves outcomes related to physical function and quality of life in adults with LBP in adults 20-65 years old. This study will also explore whether improvements in other health metrics that are typically related to, or seen in, lower back pain research (i.e. stiffness, mobility, physical activity, validated clinical scoring methods, etc.) are improved with the use of the product.
The main question this study aims to answer is:
Read more
- Does the lumbar wrap effectively reduce low back pain symptoms and improve outcomes related to physical function and quality of life in adults with lower back pain.
Participants experiencing lower back pain will be asked to use the lower back wrap for at least 20-minutes per day for a 2-week period, counterbalanced with a 2-week period of no device use. Participants will fill out small daily surveys about their symptoms and complete a pre-, middle-, and post- survey and functional screening to determine efficacy of the device.
Read the detailed description
Participants with both acute and chronic low back pain will be recruited from the emergency department, research registry, social media, and e-mails. Participants will be screened for inclusion and exclusion criteria and consented. This study utilizes a counterbalanced cross-over design. Each participant will complete both conditions: 1) Intervention (wrap), or 2) Control (Nothing). A counterbalanced assignment approach will be used to determine the starting condition for each participant (Phase 1). After completion of Phase 1, each participant will complete the remaining condition for Phase 2.
Each phase of the intervention will take 2 weeks, for a total of 4 weeks (2 weeks in Phase 1, 2 weeks in Phase 2). When participants are in the Intervention phase of the study, they will be asked to use the lower back wrap at least once per day for the standard treatment length (20 minutes). To support ecological validity, participants will be able to use the device ad libitum (several times throughout the day) as desired. The Researchers will administer simple daily surveys to log compliance to treatment.
A pre-, mid-, and post- survey and functional screening will be conducted to gather additional information about the participant and device efficacy and use.
- Being tested
- Low back pain wrap
- Keywords
- Low back pain, acute low back pain, symptom reduction, pain sensation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low back pain wrapDevice
The low back pain wrap device includes heat, vibration, and red light to assist with reducing pain sensation, improving function.
| Study group | Role | What they receive |
|---|---|---|
| Lower back pain wrap | Experimental | During this arm the participants will wear the low back pain wrap device Receives: Device: Low back pain wrap |
| No device | No intervention | No device will be used, but symptoms and function will be reported |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Patients will report their level of pain daily and reflect on their pain over the past over the past 1-week at the start of the study and past 2-weeks during the follow-up surveys
Pain Scale: 1-10, higher score = more pain.
Measured: From enrollment to the end of treatment at 4 weeks
Function survey
Function will be assessed daily and every 2-weeks by survey.
Measured: From enrollment to the end of treatment at 4 weeks
Function test
Function will be assessed every 2-weeks by a function screening via 5-repitition sit-to-stand.
Function Scale: 5 point scale from "not at all" to "very much" indicating how much pain interfered with day-to-day activities.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (5)
Medication usage
Daily screening and every 2-weeks the participants will be asked about what prescription and over-the-counter medications, along with cannabis and THC, were used to help mediate the pain.
Measured: From enrollment to the end of treatment at 4 weeks
Other pain and rehabilitation use
Participants will be surveyed daily and every 2-weeks about any other type of rehabilitation they used to help mediate their pain.
Measured: From enrollment to the end of treatment at 4 weeks
Device use- Frequency
Frequency of use will be recorded daily during the 2-week device intervention period
Frequency scale: 0-5+ on a 6 point scale indicating how often the device was used per day.
Measured: For the 2-week device use period.
Device use- Duration
Duration of use will be recorded daily during the 2-week device intervention period
Scale: 2 point- default (20-minutes) or more. Free response in branching logic to insert amount of time if more than default.
Measured: For the 2-week device use period.
Device use- Type
Type of use will be recorded daily during the 2-week device intervention period.
Scale 1- How worn, gives options for under/over clothes \& activity, resting, sitting, standing, ADLs, free response.
Measured: For the 2-week device use period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start2 Dec 2024
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Kelleran, State University of New York at Buffalo
- Investigators
- Kyle J Kelleran, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749912
- Sponsor's protocol ID
- STUDY00008828
- Status last verified
- Aug 2025
- First submitted
- 9 Dec 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
- ClinicalTrials.gov ID
- NCT06749912
- Acronym / sponsor ID
- STUDY00008828
- Keywords
- Low back pain, acute low back pain, symptom reduction, pain sensation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 27 Dec 2024 (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 goal of this counterbalanced cross-over study is to determine whether a recovery lumbar wrap effectively reduces lower back pain and improves outcomes related to physical function and quality of life in adults with LBP in adults 20-65 years old. This study will also explore whether improvements in other health metrics that are typically related to, or seen in, lower back pain research (i.e. stiffness, mobility, physical activity, validated clinical scoring methods, etc.) are improved with the use of the product.
The main question this study aims to answer is:
- Does the lumbar wrap effectively reduce low back pain symptoms and improve outcomes related to physical function and quality of life in adults with lower back pain.
Participants experiencing lower back pain will be asked to use the lower back wrap for at least 20-minutes per day for a 2-week period, counterbalanced with a 2-week period of no device use. Participants will fill out small daily surveys about their symptoms and complete a pre-, middle-, and post- survey and functional screening to determine efficacy of the device.
Detailed description
Participants with both acute and chronic low back pain will be recruited from the emergency department, research registry, social media, and e-mails. Participants will be screened for inclusion and exclusion criteria and consented. This study utilizes a counterbalanced cross-over design. Each participant will complete both conditions: 1) Intervention (wrap), or 2) Control (Nothing). A counterbalanced assignment approach will be used to determine the starting condition for each participant (Phase 1). After completion of Phase 1, each participant will complete the remaining condition for Phase 2.
Each phase of the intervention will take 2 weeks, for a total of 4 weeks (2 weeks in Phase 1, 2 weeks in Phase 2). When participants are in the Intervention phase of the study, they will be asked to use the lower back wrap at least once per day for the standard treatment length (20 minutes). To support ecological validity, participants will be able to use the device ad libitum (several times throughout the day) as desired. The Researchers will administer simple daily surveys to log compliance to treatment.
A pre-, mid-, and post- survey and functional screening will be conducted to gather additional information about the participant and device efficacy and use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower back pain wrap | Experimental | Device: Low back pain wrapDuring this arm the participants will wear the low back pain wrap device |
| No device | No intervention | –No device will be used, but symptoms and function will be reported |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 20 - 65
- Males and Females (50-50 split or close)
- Range of ethnicities
- Range of BMIs
Key exclusion criteria (5 listed)
- Those with diagnosed cancer, infection, trauma, or LBP requiring surgical intervention
- Those currently undergoing rehabilitation treatment for LBP
- Those with other diagnosed conditions that may preclude them from safely participating
- Pregnant women
- Waist less than 26" or greater than 66" due to device limitations
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 |
|---|---|---|
| Low back pain wrapThe low back pain wrap device includes heat, vibration, and red light to assist with reducing pain sensation, improving function. | Device | Lower back pain wrap |
Primary outcome
Pain
Time frame: From enrollment to the end of treatment at 4 weeks
Patients will report their level of pain daily and reflect on their pain over the past over the past 1-week at the start of the study and past 2-weeks during the follow-up surveys Pain Scale: 1-10, higher score = more pain.
Function survey
Time frame: From enrollment to the end of treatment at 4 weeks
Function will be assessed daily and every 2-weeks by survey.
Function test
Time frame: From enrollment to the end of treatment at 4 weeks
Function will be assessed every 2-weeks by a function screening via 5-repitition sit-to-stand. Function Scale: 5 point scale from "not at all" to "very much" indicating how much pain interfered with day-to-day activities.
5 secondary outcomes
Medication usage
Time frame: From enrollment to the end of treatment at 4 weeks
Other pain and rehabilitation use
Time frame: From enrollment to the end of treatment at 4 weeks
Device use- Frequency
Time frame: For the 2-week device use period.
Device use- Duration
Time frame: For the 2-week device use period.
Device use- Type
Time frame: For the 2-week device use period.
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 13 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Kyle J Kelleran, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low back pain wrap in people with Lower Back Pain and Lower Back Pain Chronic, run by State University of New York at Buffalo 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 4 inclusion and 5 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 13 Aug 2025. 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. 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?
Pain (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 3 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 13 Aug 2025.