Chiropractor Delivered Virtual Intervention After Vertebral frActure
NCT ID: NCT07288684
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-10-20
2026-06-01
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
Participants will be randomized to: 1) immediate receipt of VIVA intervention; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization.
HEALTH_SERVICES_RESEARCH
SINGLE
The waitlist control was chosen based on input from persons with lived experience, who indicated that participants may be more willing to participate if there was a wait list control rather than receiving no intervention.
Study Groups
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Immediate Receipt of VIVA
Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week one (immediately post-randomization).
Following a virtual assessment, participants will receive twelve 1:1 virtual sessions (via Zoom) over eight weeks.
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.
Control
Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week ten (waitlist control).
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Have had a vertebral fracture in the past two years
* Willing to participate in twelve (12) virtual rehabilitation sessions for 10 weeks
* Have access to internet and a smart device with a camera and microphone
Exclusion Criteria
* Had a traumatic fracture (i.e., car accident)
* An active infection
* Active inflammatory arthritis with a flare up within the past two years
* An inability to follow two-step commands or understand instructions and are without a caregiver to support participation
* Been participating in a similar rehabilitation program for vertebral fractures delivered by a physical therapist, exercise physiologist or kinesiologist and includes exercise
* Any surgeries planned or health problems that might cause their health to change significantly in the next 3 months
50 Years
ALL
No
Sponsors
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Canadian Chiropractic Research Foundation
UNKNOWN
Canadian Chiropractic Association, Canadian Chiropractic Research Foundation
UNKNOWN
University of Waterloo
OTHER
Responsible Party
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Locations
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University of Waterloo
Waterloo, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Allison A Legg
Role: primary
Lora Giangregorio, PhD
Role: backup
Other Identifiers
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CTO 4816
Identifier Type: -
Identifier Source: org_study_id