Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05375500 |
| Other study ID # |
1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
September 10, 2021 |
Study information
| Verified date |
May 2022 |
| Source |
Karuna Labs Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chronic shoulder pain is a common musculoskeletal pain condition that can have a profound
impact on a sufferer's life and a large socioeconomic healthcare burden to society. The aim
of this study was to determine the feasibility of delivering telemedicine enabled functional
shoulder rehabilitation for chronic shoulder pain patients using immersive virtual reality.
Ten chronic shoulder pain patients were recruited from local pain clinics. Patients engaged
in three sessions of virtual embodiment training per week over the course of eight weeks.
Rehabilitation sessions were delivered on an Oculus Quest head-mounted display and hand
controllers. Rehabilitation exercises (virtual embodiment training) leverage techniques from
graded motor imagery, such as visual mirror feedback and augmentation of the virtual avatar's
movements. Eight pain assessments were administered prior to the first session, and at weeks
four and eight to get an indication of the effect that telemedicine delivered virtual
embodiment training has on symptoms of chronic shoulder pain.
Description:
This study protocol was conducted in accordance with the ethical standards of the Declaration
of Helsinki and approved by ADVARRA, an independent institutional review board. Ten chronic
shoulder pain patients (7 Female, 3 Male, mean age = 48.44 years) provided written informed
consent prior to participating in the study. Eight patients presented with chronic pain of
the left shoulder and two presented with right chronic shoulder pain. Patients were recruited
from a local pain clinic. Patients were excluded if they reported a history of motion
sickness, a history of seizures, or cognitive impairments. A total of twenty-one patients
were assessed for eligibility. Two patients were excluded prior to participation for a
history of vertigo or motion sickness, and one was excluded due to color blindness. Four
patients declined to participate prior to beginning treatment. Four patients were excluded
due to impending surgeries scheduled that would prevent them from completing the study
protocol (see Figure 1 consort diagram).
Patients who volunteered to participate in the study were shipped an Oculus Quest
six-degrees-of-freedom wireless head mounted VR display (HMD) and hand controllers. Patients
were assigned a health coach to assist with the use of the VR hardware. The health coach met
with the patients via a HIPAA compliant telehealth video chat platform. Patients were
instructed on safe use of the VR headset and hand controllers and instructed on how to create
the safe play guardian of the Oculus Quest VR system and how to connect the HMD to a home
wi-fi. After the patients confirmed that they were comfortable using the Oculus Quest, they
were advised to complete three sessions of functional rehabilitation in VR exercises per week
over the course of eight weeks. All function rehabilitation exercises were self-administered
by each patient. The coach conducted telehealth video chat sessions with each patient once
per week and administered a structured curriculum that included pain neuroscience education,
goal setting, instructions for pacing and grading, and flare-up management.
Functional rehabilitation exercises were delivered through KarunaHOME (Karuna Labs, Inc, San
Francisco, CA). KarunaHOME is a virtual reality software delivered on the oculus quest to
provide rehabilitation exercises in patient's homes. KarunaHOME Virtual Embodiment Training™
consists of five functional rehabilitation exercises designed on the principles of graded
exposure and mirror therapy.
Each session of functional rehabilitation began with a calibration exercise that measured
shoulder range of motion for flexion, scaption, and abduction (Figure 2). The calibration
exercise progressed through shoulder flexion, shoulder scaption, and shoulder abduction one
at a time, on each side. The patient was instructed in VR to perform three repetitions within
a comfortable range. The calibration exercise was a measurement of a patient's comfortable
range of motion for flexion, scaption, and abduction and was used to set the limits of
subsequent exercises so that patient did not move beyond their comfortable range during that
day's session. The second exercise was a functional movement exercise that promoted shoulder
flexion, scaption, and abduction while engaged in a reach and grasp task. Patients reached
for an orb in the form of a floating lotus flower positioned in front of the patient in the
virtual environment. Patients grasped the orb by moving the hand controller, which
corresponded to movement of the virtual avatar's arm, and then pulled the trigger of the
Oculus Quest hand controller using the index finger to toss the orb into a pond by producing
either an overhand or underhand throwing motion and releasing the trigger. The second
exercise also incorporated a mirror visual feedback (MVF) manipulation where the avatar's
contralateral limb moved relative to the patient's movement. For example, if the patient
moved their right arm, they would see embodied avatar's left arm moving. MVF was used for
half the duration of each exercise. The third exercise was a reach and grasp exercise where
patients reached to grasp colorful flowers by moving the hand controller to position the
virtual avatar's arm in front of their embodied virtual avatar. The goal of this exercise was
to match flowers of the same color in sets of three or more. The patient reached up for a
flower to remove it and then the flowers above will fall into place. The exercise required
patients to reach a maximum height by continuing to remove flowers. The fourth exercise was a
painting exercise designed to promote complex dynamic shoulder motion. The goal of this
exercise was to connect numbered dots by using the hand controller to move the virtual
avatar's arm in a dynamic pattern to recreate different shapes in the sky using a virtual
paintbrush. The first few shapes were directly in front of the patient and were simple
movements such as a circle, triangle, heart. The shapes became progressively more difficult,
requiring greater shoulder range of motion for reaching above and to the side, and progressed
to more complex shapes to connect. The final exercise was a simulated activity of daily
living in the form of a bow and arrow experience. Movements were designed to mimic motions
that are included in activities of daily living such as putting on a seatbelt or shampooing
hair. There were three distinct exercises within the bow and arrow activity. In all
exercises, the patient moved the hand controller to move the virtual avatar's upper extremity
limbs in a position that was necessary to complete the task. The first exercise required
patients to reach the affected arm across body (horizontal adduction) to the quiver on the
opposite hip to grasp an arrow and then bring the arrow to the bow (shoulder flexion) and
pull back (scapular retraction) and shoot towards a target. The second exercise required
patients to reach with affected arm over and behind the opposite shoulder to the quiver to
get an arrow and then bring the arrow to the bow (shoulder flexion) and pull back (scapular
retraction) and shoot. The third exercise required patients to reach over the affected
shoulder (shoulder flexion, abduction, and internal and external rotation). Each session
progressed from the first exercise to the last exercise with one minute of a guided breathing
exercise in between each exercise. Patients completed three sessions per week over the course
of eight weeks.
Telehealth-based pain education and behavioral health coaching was administered once per
week. The first session was ninety minutes in duration and consisted of a general
introduction, a tutorial on safely using the VR hardware in the home, and general
introductions to Virtual Embodiment Training. Sessions two through eight were sixty minutes
in duration with each session addressing topics that could be applied in the virtual
embodiment exercises as well as activities of daily living. Each session included discussions
of goals to work towards, including goals within virtual embodiment exercises. Sessions also
contained pain neuroscience education, instruction on graded exposure, and behavioral
exercises designed to help patients cope with their chronic pain and manage stress with
relaxation, awareness of emotions and pain-related thoughts, mindfulness and gratitude-based
exercises.Patients were encouraged to apply what they learned in the behavioral coaching
sessions in exercised performed in VR.
The primary objective of this study was to assess the feasibility of a home-based functional
rehabilitation program delivered in VR combined with telehealth-based education and coaching.
The secondary objective was to determine appropriate outcome measures for an eventual larger
scale randomized controlled trial. To assess the potential effectiveness of VR telehealth
delivered functional rehabilitation, a battery of pain assessments were administered at three
timepoints (pre, mid, and post), prior to beginning the eight week protocol, at the midpoint
(week 4), and after completing the eight week protocol. The Disability of the Arm, Shoulder,
and Hand (DASH) questionnaire was used to assess shoulder disability. The SF-36 was used to
assess was administered to assess quality of life. The Pain Catastrophizing Scale (PCS) was
used to assess psychological aspects of pain. The Fear Avoidance Beliefs Questionnaire (FABQ)
physical activity subscale was used to assess fear of movement due to chronic pain. The Upper
Extremity Functional Index (UEFI) was used to assess shoulder function. The Tampa Scale of
Kinesiophobia (TSK) was used to assess fear of movement. The Pain Self-Efficacy Questionnaire
(PSEQ) was used to assess patient confidence. The Yellow Flag Risk Form (YFRF) was used to
assess chronic pain mechanisms. Since this was a feasibility study, additional measures were
assessed to determine appropriate outcome measures for an eventual larger randomized
controlled trial.
