Back Wrap for Lower Back Pain

Overseen By Dipesh Patel, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Cancer, Infection, Trauma, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

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. ^{1 2 3 4 5}

How 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. ^{6 7 8 9 10}

Research Team

Kyle J Kelleran, PhD

Principal Investigator

University at Buffalo

Eligibility 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

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

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

Treatment Details

Interventions

• Lower Back Wrap Device

Trial Overview 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.

Participant Groups

Group I: Lower back pain wrap Experimental Treatment 1 Intervention

During this arm the participants will wear the low back pain wrap device

Group II: No device Active Control 1 Intervention

No device will be used, but symptoms and function will be reported

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Findings from Research

Tracking outcomes is essential for monitoring the effectiveness of treatments in patients with low back pain, and clinicians must be familiar with various measurement tools to evaluate treatment success.

The article reviews the reliability and validity of common outcome measures, such as the SF-36 and Oswestry Disability Index, providing practical guidelines for their selection and use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes measurement for patients with low back pain. Resnik, L., Dobrykowski, E.[2019]

A systematic review of 8 studies found no significant evidence that lumbar elastic tape application improves trunk mobility in individuals with or without low back pain, as none of the changes exceeded the minimal detectable change.

The review suggests a need for better quality and more reliable measurement tools in future research, as the current studies did not provide conclusive results regarding the effectiveness of elastic tape application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Lumbar Elastic Tape on Trunk Mobility: A Debatable Issue. van Amstel, RN., Noten, K., van den Boomen, LN., et al.[2022]

In a study involving 219 participants with acute nonspecific low back pain, 8 hours of continuous low-level heatwrap therapy significantly improved pain relief, muscle stiffness, and flexibility compared to a placebo.

The heatwrap therapy not only provided effective pain management but also reduced disability, with mild and infrequent adverse events reported, indicating it is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous low-level heatwrap therapy for treating acute nonspecific low back pain. Nadler, SF., Steiner, DJ., Erasala, GN., et al.[2016]

In a study of 43 patients with acute work-related low back pain, those who received ThermaCare Heat Wrap combined with an education program experienced significantly reduced pain intensity and improved disability scores compared to those who only received education.

The heat therapy was applied for three consecutive days, and the benefits were observed during treatment and continued through follow-up visits, indicating its effectiveness in managing pain and enhancing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of continuous low-level heat therapy for acute muscular low back pain in the workplace. Tao, XG., Bernacki, EJ.[2019]

The study involving 98 participants with lower back pain found that an inextensible lumbosacral orthosis (iLSO) significantly improved self-rated disability scores compared to standard care and an extensible lumbosacral orthosis (eLSO), suggesting that increased trunk stiffness and motion restriction may enhance treatment outcomes.

Participants using the iLSO had 4.7 times higher odds of achieving a 50% or greater improvement in disability scores, indicating its potential effectiveness in managing lower back pain compared to standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing extensible and inextensible lumbosacral orthoses and standard care alone in the management of lower back pain. Morrisette, DC., Cholewicki, J., Logan, S., et al.[2022]

In a study of 9 patients treated with wrap-clipping for ruptured blood blister-like aneurysms, the procedure showed no permanent morbidity and all patients had excellent clinical outcomes, with a modified Rankin scale score of 0 after a mean follow-up of 61 months.

The use of advanced monitoring techniques, such as fluorescence video angiography and endoscopy, ensured the effectiveness of the wrap-clipping procedure, with only one case of aneurysm regrowth that was successfully repaired, and no other recurrences or complications observed over a mean follow-up period of 37 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Clinical and Angiographic Outcomes of Wrap-Clipping for Ruptured Blood Blister-Like Aneurysms of the Internal Carotid Artery Using Advanced Monitoring. Hanihara, M., Yoshioka, H., Kanemaru, K., et al.[2020]

In a study of 15 patients who underwent microsurgical wrapping of intracranial aneurysms (IAs), there was a 20% incidence of delayed cerebrovascular complications, including ischemic stroke and granuloma formation, highlighting potential risks associated with this treatment.

The literature review of 197 cases showed a 12% rebleeding rate in patients with ruptured aneurysms after wrapping, indicating that while the risk is lower than untreated ruptured aneurysms, it remains significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wrapping of intracranial aneurysms: Single-center series and systematic review of the literature. Perrini, P., Montemurro, N., Caniglia, M., et al.[2018]

In a follow-up study of 35 patients treated for ruptured middle cerebral artery aneurysms with gauze wrapping, only one patient experienced early recurrent hemorrhage, and there were no late hemorrhages, indicating the procedure's safety.

The treatment showed a low mortality rate of 8.6% and minimal morbidity, suggesting that gauze wrapping is an effective method for managing these aneurysms without causing occlusive infarcts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reinforcement with gauze wrapping for ruptured aneurysms of the middle cerebral artery. Taylor, JC., Choudhury, AR.[2004]

Aneurysm wrapping is a rare surgical procedure used when traditional methods like clipping or ligature cannot be performed, highlighting its role as a critical alternative in specific cases.

The article reviews the evolution of aneurysm wrapping techniques, current product options, and emphasizes the importance of perioperative nursing care to ensure patient safety and effective recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aneurysm wrapping: principles applicable to the neuroscience nurse. Rutledge, B.[2019]

A gauze sponge wrapping method was developed to prevent recurrent subarachnoid hemorrhage (SAH) in patients with incomplete obliteration of intracranial aneurysms, showing no recurrent SAH in the wrapping group during follow-up periods ranging from 3 months to 8.5 years.

In a study of 349 surgically treated aneurysms, 78 were treated with gauze wrapping, and the incidence of complications was not significantly different between the wrapping and non-wrapping groups, indicating that this method is safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wrapping of intracranial aneurysms with gauze sponge. Morioka, M., Marubayashi, T., Masumitsu, T., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcomes measurement for patients with low back pain. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Lumbar Elastic Tape on Trunk Mobility: A Debatable Issue. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Continuous low-level heatwrap therapy for treating acute nonspecific low back pain. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of continuous low-level heat therapy for acute muscular low back pain in the workplace. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing extensible and inextensible lumbosacral orthoses and standard care alone in the management of lower back pain. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Long-Term Clinical and Angiographic Outcomes of Wrap-Clipping for Ruptured Blood Blister-Like Aneurysms of the Internal Carotid Artery Using Advanced Monitoring. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Wrapping of intracranial aneurysms: Single-center series and systematic review of the literature. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Reinforcement with gauze wrapping for ruptured aneurysms of the middle cerebral artery. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

Aneurysm wrapping: principles applicable to the neuroscience nurse. [2019]

10. Japan pubmed.ncbi.nlm.nih.gov

Wrapping of intracranial aneurysms with gauze sponge. [2019]