NCT07288684

Chiropractor Delivered Virtual Intervention After Vertebral frActure

Chiropractor Delivered Virtual Intervention After Vertebral frActure (VIVA)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Waterloo · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will determine feasibility of a chiropractor delivered virtual intervention for individuals following osteoporotic vertebral fracture. This pilot trial will have two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization. VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics. A chiropractor (DC) completes a virtual assessment and then leads twelve 1:1 virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning. This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.

Detailed description

Spine fractures are the most common fracture due to osteoporosis. They can happen because of falls or activities of daily life like bending and lifting. Fractures of the spine can result in pain, which can last for a long time. Spine fractures can affect breathing, appetite, digestion, and mobility, and can restrict or modify an individuals' work or daily activities. There are no standard rehabilitation programs after spine fracture, and patients often must pay out of pocket for rehabilitation. Rehabilitation can be hard to access (especially in rural or remote locations) and it can be difficult to find providers with training and expertise to treat spine fractures. Our team includes Osteoporosis Canada, patients, health care professionals, and researchers from multiple provinces. We reviewed research, consulted patients and healthcare providers to understand their experiences with spine fracture rehabilitation to develop a Toolkit for a virtual rehabilitation program for people with spine fracture, called VIVA. VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics. We used the Behavior Change Wheel method to select four implementation strategies: education on pain management, safe movement, exercise, and nutrition; modeling of and training on exercises, safe movement, and pain management strategies; and enablement, such as goal setting, action planning, and self-monitoring. Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week one (immediately post-randomization) or in week ten (waitlist control). A provider completes a virtual assessment, and then leads 1:1 once-weekly virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning. The provider prescribes resources (e.g., summaries, pictures, videos) using the Wibbi app (https://wibbi.com/) or that can be emailed or mailed. Exercises are tailored to the participant's abilities, and target balance, muscle strength, and endurance of back extensor muscles and scapular stabilizers. The first session will serve as an intake session. Depending on the patient needs the provider either will provide training on exercises, movement tips, or pain management tips. Finally, the provider will show how to monitor performance and adherence throughout the intervention, discuss and decide on the area of focus for the next session (i.e., pain management, safe movement, exercise, nutrition), and schedule the next session. The remaining 11 sessions from Week 2 to Week 8 will start with education on the chosen topic. The provider will review progress on exercises, movement strategies, or pain management tips from the previous sessions and demonstrate new exercises or strategies. The provider will deliver the exercises prescribed and any educational resources through the Wibbi app and decide on an area of focus for the next session based on discussion with the participant. VIVA was designed and user tested in the context of physiotherapist delivery, but chiropractors may be well-situated to deliver VIVA. Chiropractors and physiotherapists manage similar patient bases with overlapping scopes of practice. We propose a pilot study of the feasibility of the implementation of the VIVA Toolkit with a chiropractor as the provider (i.e., Can we recruit people? Do they like the program? Do they attend?). Through this study we will also collect information about pain, quality of life and physical functioning before and after the intervention. We will then use the findings of this study to determine if it is feasible to include chiropractor providers in a larger clinical trial.

Conditions

• Osteoporosis
• Vertebral Fracture

Interventions

Type	Name	Description
BEHAVIORAL	VIVA	VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics.

Timeline

• Start date: 2025-10-20
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: Canada