Back Wrap for Lower Back Pain
Recruiting in Palo Alto (17 mi)
Overseen byKyle J Kelleran, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: State University of New York at Buffalo
Disqualifiers: Cancer, Infection, Trauma, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the Lower Back Wrap Device treatment for lower back pain?
Research shows that continuous low-level heatwrap therapy, similar to the Lower Back Wrap Device, can effectively reduce pain and disability in people with acute lower back pain, especially when used in combination with education programs.
12345How is the Lower Back Wrap Device treatment different from other treatments for lower back pain?
The Lower Back Wrap Device is unique because it offers a non-invasive, wearable solution for managing lower back pain, potentially providing continuous support and relief without the need for medication or surgery, unlike many traditional treatments.
678910Eligibility Criteria
Adults aged 20-65 with lower back pain are eligible for this study. They must be willing to use a lumbar wrap device daily and complete surveys about their symptoms. Specific inclusion and exclusion criteria details were not provided.Inclusion Criteria
I am either male or female, fitting into the study's gender ratio requirement.
Range of BMIs
Range of ethnicities
+1 more
Exclusion Criteria
Waist less than 26" or greater than 66" due to device limitations
I am currently in rehab for lower back pain.
Those with other diagnosed conditions that may preclude them from safely participating
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Intervention Phase 1
Participants use the lower back wrap for at least 20 minutes per day for 2 weeks
2 weeks
Daily surveys
Intervention Phase 2
Participants do not use the device for 2 weeks, but symptoms and function are reported
2 weeks
Daily surveys
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
Participant Groups
The trial is testing if a lumbar wrap can reduce low back pain and enhance physical function and quality of life. It's a cross-over study, meaning participants will alternate between using the wrap and not using it over two-week periods.
2Treatment groups
Experimental Treatment
Active Control
Group I: Lower back pain wrapExperimental Treatment1 Intervention
During this arm the participants will wear the low back pain wrap device
Group II: No deviceActive Control1 Intervention
No device will be used, but symptoms and function will be reported
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University at BuffaloBuffalo, NY
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Who Is Running the Clinical Trial?
State University of New York at BuffaloLead Sponsor
References
Outcomes measurement for patients with low back pain. [2019]Outcomes tracking provides a systematic method of monitoring treatment effectiveness and efficiency. A familiarity with outcome measures for the patient with low back pain is very important for clinicians working in orthopaedic settings, where patients with lumbar pain are prevalent. The clinician must be able to evaluate and choose appropriate measurement tools, and understand the clinical meaning of measurements to successfully employ these instruments. The purposes of this article are to review measurement instruments and to offer practical guidelines for selection and use of outcome measures for this population. The reliability, validity, sensitivity to change, and utility of common outcome measures are discussed. An overview of generic, disease-specific, and patient-specific tools is provided, with specific commentary on the use of the SF-36, SF-12, Oswestry, Roland Morris, and patient-specific tools. Practical guidelines for utilizing outcome measures in clinical practice and the overall benefits of outcomes tracking are highlighted.
Systematic Review of Lumbar Elastic Tape on Trunk Mobility: A Debatable Issue. [2022]To systematically review the literature to analyze the effect of lumbar elastic tape application on trunk mobility, surpassing the minimal detectable change of the used outcome measurement tool, and to analyze the additional effect of applied tension and direction of elastic tape application in low back pain and participants without low back pain.
Continuous low-level heatwrap therapy for treating acute nonspecific low back pain. [2016]To evaluate the efficacy of 8 hours of continuous low-level heatwrap therapy for the treatment of acute nonspecific low back pain (LBP).
A randomized clinical trial of continuous low-level heat therapy for acute muscular low back pain in the workplace. [2019]We sought to compare the therapeutic benefits of ThermaCare Heat Wrap combined with an education program to an education-only program on reducing pain and disability from acute work-related low back pain.
A randomized clinical trial comparing extensible and inextensible lumbosacral orthoses and standard care alone in the management of lower back pain. [2022]Single blinded, randomized clinical trial for the evaluation of lumbosacral orthoses (LSOs) in the management of lower back pain (LBP).
Long-Term Clinical and Angiographic Outcomes of Wrap-Clipping for Ruptured Blood Blister-Like Aneurysms of the Internal Carotid Artery Using Advanced Monitoring. [2020]Wrap-clipping is one of the recommended treatments for ruptured blood blister-like aneurysms (BBAs) of the internal carotid artery (ICA). However, the long-term clinical and angiographic outcomes of this procedure have not yet been elucidated. The present study examined the long-term efficacy of wrap-clipping using a polytetrafluoroethylene membrane, an ideal wrapping material, for BBAs.
Wrapping of intracranial aneurysms: Single-center series and systematic review of the literature. [2018]Circumferential wrapping of the aneurysm wall with a variety of materials is a well-known therapeutic approach for the repair of unclippable intracranial aneurysms (IAs). Wrapping materials can stimulate foreign-body inflammatory reactions and parent artery narrowing with resultant ischemic stroke. In this study, a single-center retrospective review of the outcome with wrapping of IAs is presented beside an analysis of existing literature.
Reinforcement with gauze wrapping for ruptured aneurysms of the middle cerebral artery. [2004]A 2- to 15-year follow-up study is presented of a series of 35 consecutive patients treated for ruptured aneurysms of the middle cerebral artery by reinforcement with gauze wrapping. Only one patient suffered early recurrent hemorrhage in the postoperative period, and none had a late hemorrhage. The procedure carried a relatively low mortality rate (8.6%). Morbidity was the direct sequel of preoperative conditions. Wrapping is an effective and safe treatment of these aneurysms, with a low mortality and morbidity, and freedom from occlusive infarcts.
Aneurysm wrapping: principles applicable to the neuroscience nurse. [2019]Aneurysm wrapping is an uncommon procedure used only when clipping or ligature is not feasible. This article contains a brief discussion of the various modalities of aneurysm wrapping in its early years, product options available today, characteristics and manifestations of intracranial aneurysms and a synopsis of the surgical procedure. In addition, perioperative nursing care is discussed.
Wrapping of intracranial aneurysms with gauze sponge. [2019]A gauze sponge wrapping method to prevent recurrent subarachnoid hemorrhage (SAH) after incomplete obliteration of intracranial aneurysm or a residual neck after clipping was developed and tested. The authors performed the gauze wrapping for aneurysms with incomplete obliteration by clipping alone, abnormal changes of the parent artery wall which had the possibility of regrowth or rerupture, and surgical difficulties. The residual neck of the aneurysm or the abnormal arterial wall was tightly and completely wrapped, including the parent artery, and cemented with plastic adhesive. Seventy-eight (22.3%) of 349 surgically treated aneurysms were treated by gauze wrapping (26 wrapping only, 52 clipping and wrapping). The incidence of complications such as infection, angiospasm, and normal pressure hydrocephalus, and the clinical outcome were not significantly different for the wrapping and non-wrapping groups. No recurrent SAH was observed in the wrapping group during 3 months to 8.5 years follow-up. These results suggest that wrapping with gauze sponge is useful in the treatment for ruptured aneurysms which cannot be totally obliterated.