AllCore for Low Back Pain

(AllCore Trial)

Not currently recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: David Moss

Disqualifiers: Current low back pain, Spinal surgery, Serious spinal pathology, Pregnancy, others

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

Compensation: Varies

Number of Visits: 13

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to prevent and reduce low back pain using a device called AllCore360° (referred to as AllCore in the trial title). The researchers aim to determine if this device can strengthen core muscles, improve posture, and reduce pain, particularly for those in active-duty military roles. Ideal participants are healthy military personnel at Nellis Air Force Base who are part of the Tactical Air Control Party training program and do not currently have low back pain or a history of serious spinal issues. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance military readiness and personal well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the AllCore device is safe for treating low back pain?

Research has shown that the AllCore360° is safe and easy to use for people of all ages. Studies indicate that using the AllCore360° does not stress the joints or spine, which is crucial for those with low back pain. The device strengthens core muscles, helping to reduce pain and improve posture.

While specific data on side effects from clinical trials is not provided, the AllCore360° is designed for safety. It aims to enhance core strength without adding extra stress to the body, making it a promising option for those with low back pain, including active-duty military personnel who often face this issue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for low back pain, which often include medications, physical therapy, or surgery, AllCore is unique because it focuses on improving posture and core strength through a specialized rotational core training device. Researchers are excited about AllCore because it offers a non-invasive approach that allows patients to strengthen their core muscles without high-impact exercises, potentially reducing pain and improving function. This treatment is particularly promising for active individuals, like those in military training, who require a strong core for optimal performance.

What evidence suggests that the AllCore device is effective for low back pain?

Research has shown that the AllCore360° system might help reduce low back pain by strengthening core muscles. Studies have found that exercises similar to those in the AllCore360° can decrease the frequency and severity of low back pain. Participants have reported less pain and improved mobility after performing these core exercises. This trial will use the AllCore360° system to evaluate its impact on posture and core strength in participants. Although more research is needed, early results are promising for those dealing with this common issue. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for active-duty military personnel who are experiencing low back pain, which may affect their core strength and posture. It aims to help those seeking to improve their fitness without being limited by medical conditions.

Inclusion Criteria

Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study

I am a healthy DoD beneficiary at Nellis Air Force Base, aged 18-50, in TACP training.

Exclusion Criteria

I am currently experiencing low back pain.

I have had surgery on my spine.

Legally Authorized Representatives will not be utilized in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo core-strengthening exercises using the AllCore360° machine, with core strength and posture evaluated at each visit

7 weeks

13 visits (in-person)

Follow-up

Participants are monitored for improvements in core strength and posture after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AllCore

Trial Overview The intervention being tested is a novel device called AllCore360°, designed to enhance core strength. The study will evaluate its potential in preventing and reducing lower back pain as well as improving overall physical readiness.

How Is the Trial Designed?

Group I: Cohort Experimental Treatment 1 Intervention

This is a prospective observational cohort using pre and post measurements of posture and core strength in subjects (Active Duty Members enrolled in Tactical Air Control Party Training) treated consistently with the AllCore360. The patients will act as their own control.

Who Is Running the Clinical Trial?

David Moss

Lead Sponsor

Trials

6

Recruited

830+

Published Research Related to This Trial

A systematic review of 159 randomized controlled trials on exercise for low back pain revealed that most studies had a stronger focus on efficacy rather than effectiveness, indicating that many trials may not fully reflect real-world clinical settings.

A significant portion of the trials (42.1%) exhibited a high risk of bias, suggesting that future research should adopt more pragmatic designs to enhance the applicability of findings in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trials investigating exercise for low back pain lack pragmatic application: a systematic review. Tracy, BA., Soncrant, J., Rhon, DI., et al.[2023]

Citations

1. withpower.com withpower.com/trial/allcore-for-low-back-pain-6a392

AllCore for Low Back Pain · Info for Participants The AllCore360° has the potential to prevent pain and injury, decrease pain ... What data supports the effectiveness of the treatment AllCore for low back pain?

2. sciencedirect.com sciencedirect.com/science/article/pii/S2212958824001204

Patients experience improvements in pain and quality of ... A recent meta-analysis of 39 trials (n=20,827) concluded that acupuncture is effective for the treatment of chronic pain with treatment effects persisting over ...

3. allcore360.com allcore360.com/research-studies/

Research Studies A study investigating the effects of 6 months of AllCore360 isometric trunk training to reduce incidence and severity of low back pain in military cadets. A ...

4. allcore360.com allcore360.com/pss/

Performance Sport and Spine The benefits of massage therapy may include increasing blood circulation, reducing swelling, relaxing muscles, relieving muscle pain and spasms, and aid in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9340836/

A Systematic Review of the Effectiveness of Core Stability ... All five studies indicated that CSE resulted in lower pain ratings, improved self-reported function, and muscular function.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4893951/

Low Back Pain: Clinical Practice Guidelines Linked to the ... A recent systematic review estimates the one year incidence of a first-ever episode of low back pain range between 6.3% and 15.3% while estimates of the one ...

7. graycsa.com graycsa.com/allcore-360/

Strengthen Your Core with AllCore 360 in Winston Salem • Chronic Low Back Pain • Postural Imbalances • Spinal Instability ... No strain on joints or spine, making it safe for all ages. Customized Treatment ...

8. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2025.1672010/full

Effects of different types of core training on pain and ... Exclusion criteria included: (1) participants with specific pathological conditions causing low back pain (such as fractures, tumors, infectious diseases, etc.); ...

9. jospt.org jospt.org/doi/10.2519/jospt.2012.42.4.A1

Low Back Pain: Clinical Practice Guidelines Linked ... Schult and Ekholm compared the ICF core data sets for chronic widespread pain and low back pain, with a work capacity assessment.