Virtual Chiropractic Intervention for Spinal Fracture

(VIVA Trial)

Overseen By Lora Giangregorio, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Waterloo

Disqualifiers: Spinal cord injury, Traumatic fracture, Active infection, Inflammatory arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a virtual chiropractic program, called VIVA, can assist individuals who have experienced a vertebral fracture due to osteoporosis. The program focuses on pain management, safe movement, exercise, and nutrition through online sessions with a chiropractor. Participants will either begin the program immediately or after a short wait. Ideal candidates have had a vertebral fracture in the past two years, are over 50, and can attend virtual sessions with internet access. As an unphased trial, this study provides a unique opportunity to explore innovative virtual care options for managing fractures related to osteoporosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual chiropractic intervention is safe for individuals with spinal fractures?

Research has shown that the VIVA program, a virtual course for individuals with spine fractures, has been tested for safety and effectiveness. This program includes online sessions with a chiropractor covering pain management, safe movement, exercise, and nutrition.

In past studies, participants handled this type of virtual program well. The focus on teaching and guided exercises is generally safe. The available research has reported no serious side effects.

Overall, the program is designed to be safe and helpful. Participants learn exercises and strategies to manage their condition, likely contributing to its positive safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VIVA treatment for spinal fractures because it leverages virtual technology to provide chiropractic care directly to patients at home. Unlike traditional in-person treatments that require travel and scheduling, VIVA offers a series of twelve personalized sessions via Zoom over eight weeks, making it more accessible and convenient. This virtual approach can potentially extend chiropractic care to individuals who might otherwise face barriers in accessing treatment, such as mobility issues or geographic limitations. By integrating technology with chiropractic interventions, VIVA could revolutionize how patients recover from spinal fractures, offering a new level of flexibility and potentially improving patient outcomes.

What evidence suggests that this virtual chiropractic intervention is effective for spinal fractures?

Research has shown that virtual programs like VIVA, which participants in this trial may receive, can help people with spine fractures improve their physical abilities and balance. Early results suggest this method can lessen pain and reduce fear of movement, both crucial for recovery. The program covers key areas such as pain management, safe movement, exercise, and nutrition, all vital for healing. The online format provides personalized support through one-on-one sessions with a chiropractor. This structured assistance helps individuals follow their exercise routines and manage their recovery safely. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with osteoporosis who have had a vertebral fracture but are not suitable candidates for drugs that prevent bone loss. Participants should be willing to engage in virtual sessions and follow an exercise program.

Inclusion Criteria

I am over 50 years old or a post-menopausal woman.

I have had a broken bone in my spine within the last two years.

Have access to internet and a smart device with a camera and microphone

Exclusion Criteria

I am already in a rehab program for spine fractures that includes exercise.

Had a traumatic fracture (i.e., car accident)

I currently have an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Technology Consultation

Participants receive a technology consultation prior to baseline assessment

1-2 weeks

1 visit (virtual)

Treatment

Participants receive twelve 1:1 virtual sessions over eight weeks, focusing on pain management, safe movement, exercise, and nutrition

8 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• VIVA

Trial Overview

The VIVA program, delivered virtually by chiropractors, is being tested. It includes education on pain management, safe movement, exercise, nutrition, and personalized goal setting over twelve Zoom sessions across eight weeks.

How Is the Trial Designed?

Group I: Immediate Receipt of VIVA Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

Participants receive a technology consultation 1-2 weeks prior to baseline assessment, and receive intervention in week ten (waitlist control).

Who Is Running the Clinical Trial?

University of Waterloo

Lead Sponsor

Trials

132

Recruited

221,000+

Canadian Chiropractic Research Foundation

Collaborator

Trials

2

Recruited

270+

Canadian Chiropractic Association, Canadian Chiropractic Research Foundation

Collaborator

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12228205/

Virtual Intervention for Vertebral frActures (VIVA)

Descriptive analyses (e.g. mean, count, percentage) will be performed for primary feasibility outcomes and secondary outcomes. Discussion. The ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40618179/

Virtual Intervention for Vertebral frActures (VIVA)

The purpose of the study is to investigate the feasibility of a multicentre randomized controlled trial of an 8-week virtual rehabilitation intervention.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06650410

Virtual Intervention for Vertebral frActure: a Pilot, Feasibility ...

As secondary outcomes, the research team will explore the effect of the intervention on physical function and balance, pain, fear of movement, falls, falls self ...

4.

arthritisresearch.ca

arthritisresearch.ca/viva-virtual-intervention-for-vertebral-fractures/

VIVA: Virtual Intervention for Vertebral Fractures

VIVA aims to determine the feasibility of a study evaluating whether people with spine fractures would benefit from education and training.

5.

ctv.veeva.com

ctv.veeva.com/study/chiropractor-delivered-virtual-intervention-after-vertebral-fracture

Chiropractor Delivered Virtual Intervention After Vertebral ...

VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It ...

6.

trialx.com

trialx.com/clinical-trials/listings/298736/virtual-intervention-for-vertebral/

Virtual Intervention for Vertebral frActure: a Pilot, Feasibility ...

A multicenter trial will be conducted to investigate the feasibility of a future trial of VIVA in adults with spine fractures in Ontario, ...