Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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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 program Participants will participate in 60 minute training sessions to see if there are effects to their CLBP.

Detailed Description
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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: to assess the effect of non-weightbearing stationary ellipticals (Cubii, Fitness Cubed Inc.) on clinical outcomes including vital signs, pain, disability, analgesic use, mental health, abdominal muscle strength, and compliance in patients with CLBP to assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the program. 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.

Official Title
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Using Non-Weightbearing Stationary Elliptical Machines and Virtual Reality for Patients With Chronic Nonspecific Low Back Pain; A Prospective Clinical Trial

Conditions
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Chronic Low-back Pain, Low Back Pain

Intervention / Treatment
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* Other: Using sitting ellipticals
* Other: Physiotherapy Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18 to 70 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 surgeon Pain 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 osteoporosis A metabolic disease affecting the CLBP, or neuromuscular disease (as assessed by the American College of Sports Medicine pre-exercise screening tool for cardiovascular risk factors prior to entry into an exercise program) Pregnancy Ankle and foot injuries inhibiting them from cycling recently (<3 mo.) Participation in another exercise program or physiotherapy (i.e., manipulation, mobilization, range of motion, massage).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 32 patients with non-specific low back pain will be allocated to the physiotherapy group. 32 patients with non-specific low back pain will be allocated to the physiotherapy + sitting elliptical group. They will be receive routine physiotherapy care based on the protocols for non-specific low back pain and using the ellipticals will not affect the process of the treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NSLBP treated with Physiotherapy<br>32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert. | Other: Physiotherapy Protocol<br>* Routine physiotherapy protocol<br>* Other names: Physiotherapy;|
| Other: NSLBP treated with Physiotherapy + Sitting ellipticals<br>32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert together with planned training using sitting ellipticals | Other: Using sitting ellipticals<br>* Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical<br>* Other names: Cubii Ellipticals;Other: Physiotherapy Protocol<br>* Routine physiotherapy protocol<br>* Other names: Physiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate in beats/minute | 8 weeks | 
| Pain Visual Analogue Scale (VAS) | Pain scores based on the Visual Analogue Scale 0-10 | 8 weeks | 
| Pain Catastrophizing Scale (PCS) | 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. | 8 weeks | 
| Oswestry Low Back Pain Disability Index (ODI) | 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. | 8 weeks | 
| Transversus abdominis endurance (TAE) | 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. | 8 weeks | 
| Fear-Avoidance Beliefs Questionnaire (FABQ) | 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) | 8 weeks | 
| Patient reported outcome measures (PROM) | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of exercise in each session | Duration of exercise in each session as feedback on the session | 8 weeks | 
| Satisfaction rate (0-10) | Satisfaction rate (0-10) as feedback on the session | 8 weeks | 
| Compliance (duration of continuing the sessions) | Compliance (duration of continuing the sessions) as feedback on the session | 8 weeks | 
| Intention to continue the sessions (0-10) | Intention to continue the sessions (0-10) as feedback on the session | 8 weeks | 
| Distance passed on the stationary elliptical | Distance passed on the stationary elliptical as elliptical measurement in kilometers | 8 weeks | 
| Total strides | Total strides as elliptical measurement | 8 weeks | 
| Time series of the stride/minute | Time series of the stride/minute as elliptical measurement | 8 weeks | 
| Average strides/minute | Average strides/minute as elliptical measurement | 8 weeks | 
| Distance traveled in each section | Distance traveled in each section as elliptical measurement in kilometers | 8 weeks |