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NCT05724160
Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain
Conditions: Chronic Low-back Pain, Low Back Pain
Sex: All
Ages: 18 Years – 55 Years
Phase: NA
Enrollment: 64
Sponsor: Massachusetts General Hospital
Summary
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: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.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.
Eligibility Criteria
Inclusion Criteria:Adults aged 18 to 55 years and CLBP (>12 wk) located between the costal margins and inferior gluteal folds.Exclusion Criteria:The presence of a postural abnormality contributing to the diagnosis reported by an expert spine surgeonPain radiating below the knee, past medical history or current symptomatic lumbar disc hernia or fracture based on expert reports (i.e.
orthopedic surgeon or radiologist)History of back surgery, inflammatory joint disease, severe osteoporosisA metabolic disease affecting the CLBP, or neuromuscular disease (as assessed by American College of Sports Medicine pre-exercise screening tool for cardiovascular risk factors prior to entry into an exercise program)PregnancyAnkle and foot injuries inhibiting them from cycling recent (<3 mo.)Participation in another exercise program or physiotherapy (i.e., manipulation, mobilization, range of motion, massage).
Source: ClinicalTrials.gov (NCT05724160). StuddyBuddy aggregates publicly available trial information.