AllCore for Low Back Pain

(AllCore Trial)

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

43 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment AllCore for low back pain?

The research on cognitive behavioral treatments for chronic low back pain shows that such programs can improve daily functioning and quality of life, with results comparable to spinal surgery. This suggests that integrated approaches, like AllCore, which may include similar components, could be effective for managing low back pain. ^{1 2 3 4 5}

How does the AllCore treatment differ from other treatments for low back pain?

The AllCore treatment is unique because it focuses on core stabilization exercises, which target the deep abdominal and trunk muscles to reduce pain and improve movement in people with chronic low back pain. This approach is different from other treatments that may not specifically target these muscle groups. ^{1 6 7 8 9}

What is the purpose of this trial?

Low back pain is one of the most common chief complaints amongst adult patients in the ambulatory clinic and emergency settings and poor core strength is a known underlying cause/perpetuator. Additionally, it is one of the most common reasons active-duty military personnel seek medical care (absolute 2015; absolute 2016; absolute 2017). Moreover, musculoskeletal conditions represent a common reason service members are placed on limited duty and considered medically not fit to deploy. The AllCore360° has the potential to prevent pain and injury, decrease pain as well as reduce duty, fitness and mobility restrictions in active-duty members with low back pain.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The Sano study: justification and detailed description of a multidisciplinary biopsychosocial rehabilitation programme in patients with chronic low back pain. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Defining worthwhile and desired responses to treatment of chronic low back pain. [2013]

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

Trials investigating exercise for low back pain lack pragmatic application: a systematic review. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Daily functioning and self-management in patients with chronic low back pain after an intensive cognitive behavioral programme for pain management. [2022]

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

Isolated lumbar strengthening in the rehabilitation of chronic low back pain. [2014]

6. Japan pubmed.ncbi.nlm.nih.gov

Effects of the CORE Exercise Program on Pain and Active Range of Motion in Patients with Chronic Low Back Pain. [2022]

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

Rationale, design, and protocol for the prevention of low back pain in the military (POLM) trial (NCT00373009). [2022]

8. England pubmed.ncbi.nlm.nih.gov

The effects of the CORE programme on pain at rest, movement-induced and secondary pain, active range of motion, and proprioception in female office workers with chronic low back pain: a randomized controlled trial. [2015]

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

A meta-analysis of core stability exercise versus general exercise for chronic low back pain. [2021]