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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

Must not have

History of back surgery, inflammatory joint disease, severe osteoporosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fear-Avoidance Beliefs Questionnaire (FABQ)

Heart rate

Oswestry Low Back Pain Disability Index (ODI)

+4 more

Secondary study objectives

Average strides/minute

Compliance (duration of continuing the sessions)

Distance passed on the stationary elliptical

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met