Clinical trial NCT06749912: Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
Official title: Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Back Pain
Lower Back Pain Chronic
Acute Low Back Pain
Keywords: Low back pain
acute low back pain
symptom reduction
pain sensation
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 20 - 65
* Males and Females (50-50 split or close)
* Range of ethnicities
* Range of BMIs

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Function survey
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Function test
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Medication usage
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Other pain and rehabilitation use
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Device use- Frequency
timeFrame: For the 2-week device use period.
measure: Device use- Duration
timeFrame: For the 2-week device use period.
measure: Device use- Type
timeFrame: For the 2-week device use period.
Other outcomes:
measure: Device use satisfaction
timeFrame: At the end of the 2-week device use period.
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Kyle J Kelleran, PhD
role: PRINCIPAL_INVESTIGATOR
References: