Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT05724160
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 program
Participants will participate in 60 minute training sessions to see if there are effects to their CLBP.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
There are controversies on whether exercise is more effective than placebo among different clinical studies specifically in acute LBP; however, in CLBP cases, evidence strongly recommends that exercise is more effective than conservative treatment on pain and functional abilities, especially individually designed exercise programs for stabilizing and strengthening. The aims of the present study are:
The training sessions will be up to 60 minutes and will include a) introduction to the goals of the session (5 minutes), b) warm-up and stretching (10 minutes), c) low resistance flat road cycling (low resistance, low cadence; 10 minutes), d) flat road cycling (high resistance, low cadence; 10 minutes), e) flat road sprint (low resistance, high cadence; 10 minutes), f) warm-down, whole-body stretching, questions and answers (Q&A; 10-15 minutes) obtained from investigations on the similar topic. The training sessions will be supervised by both an expert clinical researcher with MD degree who is familiar with healthcare principles for these patients and also by a US licensed board-certified orthopaedic surgeon, who is responsible for providing routine orthopaedic care for the patients in this study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical
Other names: Cubii Ellipticals
Routine physiotherapy protocol
Other names: Physiotherapy
Time frame: 8 weeks
Heart rate in beats/minute
Time frame: 8 weeks
Pain scores based on the Visual Analogue Scale 0-10
Time frame: 8 weeks
Mental health based on the Pain Catastrophizing Scale (PCS). 13-item questionnaire to identify catastrophic thoughts or feelings in relation to painful experiences. The total score ranges from 0 to 52, with high scores indicating that more catastrophic thoughts or feelings are experienced.
Time frame: 8 weeks
Measure of disability based on the Oswestry Low Back Pain Disability Index (ODI). Version 2, 10-item questionnaire on how LBP affects aspects of their life (0%-100% scoring.
Time frame: 8 weeks
Abdominal strength based on Transversus abdominis endurance (TAE). Holding or tonic capacity of transversus abdominis measured by the number of 10-second holds (up to 10) using pressure biofeedback in prone position.
Time frame: 8 weeks
Patient's beliefs about the potential harm of work or general physical activity to their back pain. Two subscales within the FABQ have been identified, a 7-item work subscale score (FABQw, score range 0-42), and a 4-item physical activity subscale score (FABQa, score range 0-24)
Time frame: 8 weeks
PROMIS-29 profile v1.0 (for Physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social role, pain inference (+pain inference short form 6b), pain intensity, depression, mood and anxiety.
Time frame: 8 weeks
Duration of exercise in each session as feedback on the session
Time frame: 8 weeks
Satisfaction rate (0-10) as feedback on the session
Time frame: 8 weeks
Compliance (duration of continuing the sessions) as feedback on the session
Time frame: 8 weeks
Intention to continue the sessions (0-10) as feedback on the session
Time frame: 8 weeks
Distance passed on the stationary elliptical as elliptical measurement in kilometers
Time frame: 8 weeks
Total strides as elliptical measurement
Time frame: 8 weeks
Time series of the stride/minute as elliptical measurement
Time frame: 8 weeks
Average strides/minute as elliptical measurement
Time frame: 8 weeks
Distance traveled in each section as elliptical measurement in kilometers
Massachusetts General Hospital
Other
Using Non-Weightbearing Stationary Elliptical Machines and Virtual Reality for Patients with Chronic Nonspecific Low Back Pain; a Prospective Clinical Trial
Acronym: Cubii
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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