Skip to main content
OpenTrials
Completed

NCT Number: NCT05724160

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Using sitting ellipticals

Other

Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical

Other names: Cubii Ellipticals

Physiotherapy Protocol

Other

Routine physiotherapy protocol

Other names: Physiotherapy

Primary outcomes

  1. Heart rate

    Time frame: 8 weeks

    Heart rate in beats/minute

  2. Pain Visual Analogue Scale (VAS)

    Time frame: 8 weeks

    Pain scores based on the Visual Analogue Scale 0-10

  3. Pain Catastrophizing Scale (PCS)

    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.

  4. Oswestry Low Back Pain Disability Index (ODI)

    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.

  5. Transversus abdominis endurance (TAE)

    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.

  6. Fear-Avoidance Beliefs Questionnaire (FABQ)

    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)

  7. Patient reported outcome measures (PROM)

    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.

Secondary outcomes

  1. Duration of exercise in each session

    Time frame: 8 weeks

    Duration of exercise in each session as feedback on the session

  2. Satisfaction rate (0-10)

    Time frame: 8 weeks

    Satisfaction rate (0-10) as feedback on the session

  3. Compliance (duration of continuing the sessions)

    Time frame: 8 weeks

    Compliance (duration of continuing the sessions) as feedback on the session

  4. Intention to continue the sessions (0-10)

    Time frame: 8 weeks

    Intention to continue the sessions (0-10) as feedback on the session

  5. Distance passed on the stationary elliptical

    Time frame: 8 weeks

    Distance passed on the stationary elliptical as elliptical measurement in kilometers

  6. Total strides

    Time frame: 8 weeks

    Total strides as elliptical measurement

  7. Time series of the stride/minute

    Time frame: 8 weeks

    Time series of the stride/minute as elliptical measurement

  8. Average strides/minute

    Time frame: 8 weeks

    Average strides/minute as elliptical measurement

  9. Distance traveled in each section

    Time frame: 8 weeks

    Distance traveled in each section as elliptical measurement in kilometers

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Fitness Cubed Inc.

Registry information

Official study title

Using Non-Weightbearing Stationary Elliptical Machines and Virtual Reality for Patients with Chronic Nonspecific Low Back Pain; a Prospective Clinical Trial

Acronym: Cubii

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Jan 7, 2025

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.

Published trials that share one or more normalized conditions with this study.