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

January 4, 2025 updated by: Soheil Ashkani Esfahani, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  1. 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
  2. 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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NSLBP treated with Physiotherapy
32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert.
Other: Physiotherapy Protocol
Routine physiotherapy protocol
Other Names:
  • Physiotherapy
Other: NSLBP treated with Physiotherapy + Sitting ellipticals
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: Physiotherapy Protocol
Routine physiotherapy protocol
Other Names:
  • Physiotherapy
Other: Using sitting ellipticals
Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical
Other Names:
  • Cubii Ellipticals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 8 weeks
Heart rate in beats/minute
8 weeks
Pain Visual Analogue Scale (VAS)
Time Frame: 8 weeks
Pain scores based on the Visual Analogue Scale 0-10
8 weeks
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.
8 weeks
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.
8 weeks
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.
8 weeks
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)
8 weeks
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.
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Fitness Cubed Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

September 22, 2024

Study Completion (Actual)

December 22, 2024

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 4, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P001905

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data acquired as specified by this protocol will be maintained and monitored by approved study staff. Approved study staff will be responsible for collecting the signed consent forms. All electronic data and subject information will be secured on non-networking password protected computers; all paperwork will be secured in locked filing cabinets. All electronic data and subject information will be secured in REDCap and will be secured on non-networking password protected computers to which only study staff will have access; all paper work will be secured in locked filing cabinets.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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