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Sitting Ellipticals for Chronic Lower Back Pain (Cubii Trial)

N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults aged 18 to 70 years and CLBP (>12 wk) located between the costal margins and inferior gluteal folds.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Cubii Trial Summary

This trial looks at how non-weightbearing elliptical exercise affects people with chronic lower back pain, to see if it can improve vital signs, pain, disability, mental health, etc.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed in your information provided about this clinical trial; generally speaking exercising on an elliptical may cause muscle soreness or strain especially if overused or used improperly.

Cubii Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old with chronic lower back pain lasting more than 12 weeks.

Cubii Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fear-Avoidance Beliefs Questionnaire (FABQ)
Heart rate
Oswestry Low Back Pain Disability Index (ODI)
+4 more
Secondary outcome measures
Average strides/minute
Compliance (duration of continuing the sessions)
Distance passed on the stationary elliptical
+6 more

Cubii Trial Design

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 Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,577 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experimental research program accept individuals aged 45 and over?

"According the stated entry requirements for this medical analysis, individuals must be between 18 and 70 years old in order to participate."

Answered by AI

Is this research study currently in the process of gathering participants?

"Affirmative, the clinicaltrials.gov website states that this research is currently in its recruitment phase. Initially posted on September 18th 2023 and last updated at the same time, 64 patients are needed to be enrolled from a single site."

Answered by AI

What are the hoped-for outcomes of this medical experiment?

"This 8-week trial aims to quantify patient pain using the Visual Analogue Scale (VAS). Other metrics that will be tracked include total strides, time series of stride/minute, and average strides/minute."

Answered by AI

What criteria must a patient satisfy to be eligible for this experiment?

"This clinical trial seeks 64 adults aged 18-70 who are experiencing chronic lower back pain and meet the anatomical criteria of being located between the costal margins and inferior gluteal folds."

Answered by AI

To what extent is the populace participating in this research?

"Affirmative. Clinicaltrials.gov confirms that this medical study, posted on September 18th 2023 and updated recently on the same date, is actively recruiting participants. A total of 64 patients are needed to be enrolled from 1 location across the world."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

Very interested in this trial to learn more potentially.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is the trial in its entirety?
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. Massachusetts General Hospital: < 24 hours
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain
Soheil Ashkani Esfahani 2023. "Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05724160.
All > Low Back Pain > Lower Back Pain
~43 spots leftby Sep 2025
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