64 Participants Needed

Sitting Ellipticals for Chronic Lower Back Pain

(Cubii Trial)

SA
KM
KT
Overseen ByKendal Toy, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to assess the effect of non-weightbearing stationary ellipticals (Cubii, Fitness Cubed, Inc.) on patient well-being with chronic lower back pain (CLBP). The main questions it aims to answer are:1. Assess the effect of non-weightbearing stationary ellipticals on clinical outcomes inclduing vital signs, pain, disability, analgesic use, mental health, abdominal muscle strength, and compliance in patients with CLBP.2. Assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the programParticipants will participate in 60 minute training sessions to see if there are effects to their 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 safety data exists for using sitting ellipticals for chronic lower back pain?

The provided research does not directly address the safety of sitting ellipticals for chronic lower back pain. However, it includes studies on various exercise interventions for back pain, such as core muscle exercises, whole-body electromyostimulation, and other exercise programs. These studies generally report positive effects on pain reduction and quality of life, with some exercises being well-tolerated. The safety and tolerability of these exercises suggest that similar low-impact, non-weightbearing exercises like sitting ellipticals may also be safe, but specific safety data for sitting ellipticals is not provided in the research.12345

Is using non-weightbearing stationary elliptical machines a promising treatment for chronic lower back pain?

Yes, using non-weightbearing stationary elliptical machines, like Cubii, is a promising treatment for chronic lower back pain because exercise is generally effective for reducing pain and improving muscle strength and flexibility.678910

What data supports the idea that Sitting Ellipticals for Chronic Lower Back Pain is an effective treatment?

The available research shows that exercise is generally effective in reducing pain and improving function for people with chronic lower back pain. Although the specific studies do not mention Sitting Ellipticals directly, they highlight that exercise, in general, is beneficial for this condition. This suggests that Sitting Ellipticals, as a form of exercise, could also be effective. However, there is no direct comparison to other treatments or specific data points for Sitting Ellipticals in the provided information.67111213

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.
See 4 more

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?
2Treatment groups
Experimental Treatment
Group I: NSLBP treated with Physiotherapy + Sitting ellipticalsExperimental Treatment2 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 PhysiotherapyExperimental Treatment1 Intervention
32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert.

Find a Clinic Near You

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

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.
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]
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.
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.
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]

Citations

Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. [2022]
Stigma experienced by people with nonspecific chronic low back pain: a qualitative study. [2022]
Effects of whole-body electromyostimulation on chronic nonspecific low back pain in adults: a randomized controlled study. [2022]
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]. [2023]
Effect of movement control and stabilization exercises in people with extension related non -specific low back pain- a pilot study. [2018]
Adverse events experienced by participants in a back pain walking intervention: A descriptive study. [2016]
Exercise Benefits for Chronic Low Back Pain in Overweight and Obese Individuals. [2018]
Tolerability and Muscle Activity of Core Muscle Exercises in Chronic Low-back Pain. [2020]
Comparison of Whole-Body Electromyostimulation versus Recognized Back-Strengthening Exercise Training on Chronic Nonspecific Low Back Pain: A Randomized Controlled Study. [2022]
10.Korea (South)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. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Walking, Cycling, and Swimming for Nonspecific Low Back Pain: A Systematic Review With Meta-analysis. [2022]
The effects of exercise using an ergometer with swaying saddle on chronic lower back pain. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Perceived and measured levels of exertion of patients with chronic back pain exercising in a hydrotherapy pool. [2019]
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