Chiropractor Delivered Virtual Intervention After Vertebral frActure

NCT07288684 | Recruiting

• 1 other identifier: CTO 4816
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Osteoporosis; Vertebral Fracture

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Feasibility of Chiropractic Delivery

  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%.

  We will consider ≥80% retention at 20 weeks acceptable. Adherence will be defined as ≥2 sessions per week of exercise at 20 weeks

Secondary Outcomes (7)

• Participant experience

  At completion of 10 weeks.

• Pain and Quality of Life

  Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only

• Health-Related Quality of life

  Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only

• Physical Performance - Balance

  Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only).

• Physical Performance - Sit to Stand Performance

  Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only)

Study Arms (2)

Immediate Receipt of VIVA

EXPERIMENTAL

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.

Behavioral: VIVA

Control

NO INTERVENTION

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

Interventions

VIVA BEHAVIORAL

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.

Immediate Receipt of VIVA

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 50 (men or post-menopausal women)
• 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

You may not qualify if:

• Cauda equina syndrome or spinal cord injury
• 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

Sponsors & Collaborators

• Canadian Chiropractic Research Foundation: collaborator
• University of Waterloo: lead
• Canadian Chiropractic Association, Canadian Chiropractic Research Foundation: collaborator

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

Allison A Legg

CONTACT

289-380-0859; a2legg@uwaterloo.ca

Lora Giangregorio, PhD

CONTACT

lora.giangregorio@uwaterloo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blind to group allocation. Participants will not be blind to group allocation because they will know what group they are assigned to. 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a pragmatic, pilot trial with two parallel groups with a 1:1 ratio. 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.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: December 17, 2025
• Study Start: October 20, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-10

Locations

CA (1)