Sitting Ellipticals for Chronic Lower Back Pain

(Cubii Trial)

Overseen By Kendal Toy, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Back surgery, Inflammatory joint disease, Severe osteoporosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the potential benefits of non-weightbearing stationary ellipticals for individuals with chronic lower back pain (CLBP). It seeks to determine if these machines can enhance pain relief, mental health, and muscle strength, and whether incorporating a virtual environment during exercise affects outcomes. Participants will engage in 60-minute sessions to assess the impact on their condition. The trial seeks individuals who have experienced CLBP for over 12 weeks but have not undergone back surgery or have serious joint diseases. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatment options for CLBP.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that using non-weightbearing stationary ellipticals is safe for patients with chronic lower back pain?

Research shows that stationary elliptical machines, which don't require weight-bearing, are generally safe for people with long-term health issues. Studies have found that these machines can be used without serious side effects. Most participants feel comfortable and secure while using them. This suggests that this type of exercise could safely help manage chronic lower back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using sitting ellipticals for chronic lower back pain because it offers a low-impact exercise option that integrates seamlessly with traditional physiotherapy. Unlike standard treatments that often focus solely on manual therapy and exercises targeting the lower back, sitting ellipticals engage the body without putting weight on the joints, potentially reducing pain and improving mobility. This method could provide patients with a more comfortable and accessible way to stay active, which is crucial for managing and alleviating chronic pain.

What evidence suggests that using non-weightbearing stationary ellipticals might be an effective treatment for chronic lower back pain?

Research has shown that exercise can help reduce chronic lower back pain (CLBP). Studies have found that exercise is more effective than doing nothing or just following usual care for this condition. In this trial, one group of participants will receive routine protocol-based physiotherapy care. Another group will receive the same physiotherapy care combined with non-weightbearing stationary elliptical machines, such as the Cubii. These machines might provide gentle exercise that can help with pain, disability, and overall well-being. Early evidence suggests these machines are beneficial because they allow movement without stressing the joints or spine. Although specific data on ellipticals for CLBP is limited, exercise remains recommended for managing chronic pain. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 70 with chronic lower back pain lasting more than 12 weeks, located between the rib cage and buttocks. It's not for those with certain spine conditions, leg pain below the knee, history of lumbar issues or back surgery, inflammatory diseases, severe osteoporosis, recent ankle/foot injuries preventing cycling, current physiotherapy participation or metabolic/neuromuscular diseases.

Exclusion Criteria

Pregnancy

I have pain extending below my knee due to a diagnosed disc hernia or fracture in my lower back.

I have had back surgery, joint disease, or severe osteoporosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 60-minute training sessions using non-weightbearing stationary ellipticals and virtual reality to assess effects on chronic low back pain.

8 weeks

Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physiotherapy Protocol
• Using Non-Weightbearing Stationary Elliptical Machines

Trial Overview The study tests if using a non-weightbearing stationary elliptical machine (Cubii) can improve well-being in people with chronic low back pain. This includes checking vital signs, pain levels, disability status, medication use for pain relief (analgesics), mental health state, abdominal muscle strength and how well participants stick to the exercise program.

How Is the Trial Designed?

Group I: NSLBP treated with Physiotherapy + Sitting ellipticals Experimental Treatment 2 Interventions

32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert together with planned training using sitting ellipticals

Group II: NSLBP treated with Physiotherapy Experimental Treatment 1 Intervention

32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Fitness Cubed Inc.

Collaborator

Trials

2

Recruited

90+

Published Research Related to This Trial

The 12-week device-driven abdominal trunk muscle strengthening program was safe for elderly participants, with no reports of increased back pain or new abdominal discomfort during the treatment.

Participants showed significant improvements in abdominal muscle strength and reductions in chronic low back pain, as well as enhanced physical function, measured by various scales including the numerical rating scale (NRS) and the Roland-Morris Disability Questionnaire (RDQ).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Abdominal Trunk Muscle Strengthening Using an Innovative Device in Elderly Patients With Chronic Low Back Pain: A Pilot Study. Kato, S., Demura, S., Kurokawa, Y., et al.[2020]

An 8-week exercise program using the Belly-bike ergometer significantly improved muscle flexibility and strength in 33 university students with chronic lower back pain.

Participants also showed notable improvements in functional tests related to back muscle flexibility, indicating that the Belly-bike can effectively help reduce lower back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of exercise using an ergometer with swaying saddle on chronic lower back pain. Byeon, SJ., Kim, KH.[2020]

A randomized controlled trial involving 110 patients with chronic low back pain showed that both whole-body electromyostimulation (WB-EMS) and conventional back-strengthening exercises significantly reduced pain intensity, with no significant difference in effectiveness between the two methods.

Both training methods also improved maximum isometric strength of trunk muscles similarly, indicating that WB-EMS can be a time-efficient alternative for patients who may struggle with traditional exercise due to time constraints or fear of movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Whole-Body Electromyostimulation versus Recognized Back-Strengthening Exercise Training on Chronic Nonspecific Low Back Pain: A Randomized Controlled Study. Weissenfels, A., Wirtz, N., Dörmann, U., et al.[2022]

Both stabilization and movement control exercise protocols effectively reduced pain and disability in individuals with non-specific chronic low back pain over a 4-week period, with no significant difference in overall effectiveness between the two types of exercises.

Movement control exercises specifically improved the flexion relaxation ratio of the iliocostalis lumbarum muscle, indicating a better normalization of muscle activation patterns compared to stabilization exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of movement control and stabilization exercises in people with extension related non -specific low back pain- a pilot study. Salamat, S., Talebian, S., Bagheri, H., et al.[2018]

A network meta-analysis of 89 studies involving 5578 adults with non-specific chronic low back pain found that Pilates is the most effective exercise for reducing pain, while resistance and stabilization/motor control exercises are best for improving physical function.

The analysis suggests that exercise training modalities, including Pilates, resistance training, and aerobic exercise, are generally more effective than therapist hands-on treatments for managing chronic low back pain, although the overall quality of the evidence is low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Owen, PJ., Miller, CT., Mundell, NL., et al.[2022]

In a study involving 13 patients with non-specific low back pain, exercises like the front plank with brace and modified curl-up were found to be the most effective for activating the rectus abdominis, with normalized EMG values around 48% to 50%.

All exercises were generally well tolerated by participants, except for the lateral plank, indicating that most of the tested exercises can be safely included in rehabilitation programs for patients with low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and Muscle Activity of Core Muscle Exercises in Chronic Low-back Pain. Calatayud, J., Escriche-Escuder, A., Cruz-Montecinos, C., et al.[2020]

A qualitative study involving 18 participants with nonspecific chronic low back pain revealed that stigma significantly affects their experience in exercise programs, impacting their willingness to seek care and participate in rehabilitation.

Stigma was found to originate from various sources, including healthcare providers and social circles, which can hinder recovery and suggests a need for public education and support to improve outcomes for individuals with low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stigma experienced by people with nonspecific chronic low back pain: a qualitative study. Slade, SC., Molloy, E., Keating, JL.[2022]

Whole-body electromyostimulation (WB-EMS) significantly reduced chronic low back pain (LBP) intensity in a study of 30 patients aged 40-70 over a 12-week period, while the control group showed no change.

The WB-EMS group also demonstrated significant improvements in maximum isometric trunk strength, indicating that this method not only alleviates pain but also enhances physical strength related to the back.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of whole-body electromyostimulation on chronic nonspecific low back pain in adults: a randomized controlled study. Weissenfels, A., Teschler, M., Willert, S., et al.[2022]

This study will assess the effectiveness of an individualized exercise rehabilitation program for non-specific chronic low back pain (NSCLBP) by comparing it to a standard program, involving 150 patients in Melbourne, Australia.

The trial aims to identify factors that influence the success of exercise programs for NSCLBP, focusing on outcomes like pain reduction, functional ability, and exercise adherence, while also incorporating participant feedback to improve future exercise prescriptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of preferred-exercise prescription compared to usual exercise prescription on outcomes for people with non-specific low back pain: a randomized controlled trial [ACTRN12608000524392]. Slade, SC., Keating, JL.[2023]

A review of 16 studies involving 1,351 overweight and obese individuals with chronic low back pain found that resistance exercise, aquatic exercise, and Pilates were most effective in reducing pain and improving quality of life and physical function.

Resistance and aquatic exercise programs had the highest adherence rates, suggesting they may be more sustainable and beneficial for long-term management of chronic low back pain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Benefits for Chronic Low Back Pain in Overweight and Obese Individuals. Wasser, JG., Vasilopoulos, T., Zdziarski, LA., et al.[2018]

In a study involving 26 patients with chronic low back pain, ratings of perceived exertion (RPE) were found to accurately predict exercise intensity during hydrotherapy when workloads were between 55% and 85% of age-predicted maximum heart rate.

At lower exercise intensities (below 55% of maximum heart rate), the relationship between RPE and exercise intensity was inconsistent, suggesting that pain levels may affect how patients perceive exertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived and measured levels of exertion of patients with chronic back pain exercising in a hydrotherapy pool. Barker, KL., Dawes, H., Hansford, P., et al.[2019]

In a 12-month study involving 229 participants with chronic back pain, those in a pedometer-based walking intervention reported a higher number of adverse events (350) compared to the usual care group (250), with musculoskeletal injuries being the most common.

Despite the increased reporting of musculoskeletal events, the study concludes that individuals with chronic back pain can safely participate in walking programs, suggesting the need for counseling on injury prevention and gradual increases in activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events experienced by participants in a back pain walking intervention: A descriptive study. Krein, SL., Abdul-Wahab, Y., Kadri, R., et al.[2016]

Walking/running is slightly more effective than doing nothing for treating chronic low back pain, but it is less effective than other interventions, according to a review of 19 trials with 2362 participants.

There is high-certainty evidence that walking/running can reduce pain and disability in the short and medium term compared to minimal or no intervention, but it does not perform as well as alternative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking, Cycling, and Swimming for Nonspecific Low Back Pain: A Systematic Review With Meta-analysis. Pocovi, NC., de Campos, TF., Christine Lin, CW., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05724160

Using Non-Weightbearing Stationary Elliptical Machines for ... A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05724160/using-non-weightbearing-stationary-elliptical-machines-for-patients-with-chronic-low-back-pain?page=40&state=MA&city=Boston

Using Non-Weightbearing Stationary Elliptical Machines ... Assess the effect of non-weightbearing stationary ellipticals on clinical outcomes inclduing vital signs, pain, disability, analgesic use, ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05724160?keyword=%22Low%20Back%22

Using Non-Weightbearing Stationary Elliptical Machines ... The aims of the present study are:~1. to assess the effect of non-weightbearing stationary ellipticals (Cubii, Fitness Cubed Inc.) on clinical outcomes ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7377601/

Pain Outcomes with an Elliptical Regimen (POWER) Study A systematic review of the effects of exercise and physical activity on non-specific chronic low back pain. In: Healthcare 2016. Jun (Vol. 4, No ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8477273/

Exercise therapy for chronic low back pain - PubMed Central We found moderate‐certainty evidence that exercise treatment is more effective for treatment of chronic low back pain compared to no treatment, usual care or ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3367158/

Impact of Elliptical Trainer Ergonomic Modifications on ... The purpose of this study was to compare, for people with disabilities and chronic conditions, perceptions of safety, comfort, workout, and usability of 4 ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0030634

Lower Back Pain (DBCOND0030634) Using Non-Weightbearing Stationary Elliptical Machines for Patients with Chronic Low Back Pain, No drug interventions, other, Not Available, completed.