NCT05724160

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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: 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.

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.

Conditions

• Chronic Low-back Pain
• Low Back Pain

Interventions

Type	Name	Description
OTHER	Using sitting ellipticals	Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical
OTHER	Physiotherapy Protocol	Routine physiotherapy protocol

Timeline

• Start date: 2023-09-18
• Primary completion: 2024-09-22
• Completion: 2024-12-22
• First posted: 2023-02-13
• Last updated: 2025-01-07

Locations

1 site across 1 country: United States