Chiropractor Delivered Virtual Intervention After Vertebral frActure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Waterloo
About this trial
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%.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
VIVA
BehavioralVIVA 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.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Immediate Receipt of VIVAExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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%.
Time frame
We will consider ≥80% retention at 20 weeks acceptable. Adherence will be defined as ≥2 sessions per week of exercise at 20 weeksSecondary outcomes
1
Participant experience
We will lead exit interviews using an interview guide with open-ended questions guided by user-centred design principles.
Time frame
At completion of 10 weeks.2
Pain and Quality of Life
Using the QUALEFFO-41 to measure health-related quality of life, the QUALEFFO-41 also includes questions on pain.
Time frame
Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only3
Health-Related Quality of life
We will use the EuroQOL instrument (EQ5D5L) to measure health-related quality of life
Time frame
Will be measured at weeks 10/20 (effectiveness) and 20 weeks (sustainability, immediate group only4
Physical Performance - Balance
We will assess static balance via three point balance scale from the Short Physical Performance Battery. Scoring: A. Side-by-side-stand Held for 10 sec ❒ 1 point Not held for 10 sec ❒ 0 points Not attempted ❒ 0 points Number of seconds held if less than 10 sec: \_\_\_\_\_\_\_ sec \*If 0 points, end Balance Tests B. Semi-Tandem Stand Held for 10 sec ❒ 1 point Not held for 10 sec ❒ 0 points Not attempted ❒ 0 points Number of seconds held if less than 10 sec: \_\_\_\_\_\_\_ sec \*If 0 points, end Balance Tests C. Tandem Stand Held for 10 sec ❒ 2 points Held for 3 to 9.99 sec ❒ 1 point Held for \< than 3 sec ❒ 0 points Not attempted ❒ 0 points (circle reason above)
Time frame
Physical performance will be measured at weeks 10/20 (effectiveness) and 20 (sustainability, immediate group only).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Waterloo
Lead sponsor
Canadian Chiropractic Research Foundation
Collaborator
Source ClinicalTrials.gov