Clinical trial NCT04413162: Using Kinect Motion Capture to Measure Shoulder Motion in Patients Undergoing Capsular Distension for Adhesive Capsulitis
Official title: Measurement of Shoulder Range of Motion Using Microsoft Kinect 2.0 in Patients Undergoing Ultrasound-guided Capsular Distension for Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Adhesive Capsulitis of Shoulder
Frozen Shoulder
Shoulder Frozen
Shoulder Pain
Mobility Limitation
Keywords: adhesive capsulitis
frozen shoulder
shoulder pain
range of motion
capsular distention
capsular distension
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will compare shoulder range of motion assessment using the Kinect motion tracking system vs goniometer in patients with adhesive capsulitis (frozen shoulder) undergoing ultrasound-guided capsular distention procedures (standard of care).

The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

Detailed description: The study will be a single-center, investigator-initiated protocol to assess the reliability of the Kinect Motion Analysis 2.0 Motion Tracking System for Range Of Motion (ROM) assessment in patients with Shoulder Adhesive Capsulitis undergoing ultrasound guided capsular distention procedures (standard of care for adhesive capsulitis). Secondarily, the study will describe the relationship between range of motion of the shoulder girdle in the four quadrants of normalized reachable workspace by the Kinect 2.0, PROMIS person-reported outcome scores for pain, pain interference and function (general mobility and upper extremity function), and VAS pain scores.

Study participants are anticipated to remain in the study for 12 weeks: an initial visit followed by 6- and 12-week follow up visits. Given the nature of scheduling appointments in medical clinics, 12 weeks is an approximation; the actual duration may occasionally be 1-2 weeks longer if needed to successfully complete the follow-up visit.

The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of limited ROM due to adhesive capsulitis
2. duration of symptoms of ≥ 3 months
3. persistent functional limitation (defined as either limitations occupationally, in independent activities of daily living, or activities of daily living)
4. X-rays and MRI excluding alternative diagnosis
5. age 18 years or older.

Exclusion Criteria:

1. prior shoulder surgery on the affected side
2. complete rotator cuff tear (based on clinical history, examination, and imaging) or planned surgical intervention on the affected side
3. ipsilateral subacromial injection within the last 3 months
4. autoimmune or rheumatologic disease affecting the joints
5. lack of scheduled same-day physical therapy appointment
6. inability to complete follow-up appointments or surveys
7. inability to provide informed consent
8. symptomatic glenohumeral or acromioclavicular pathology
9. referred pain from the neck or internal organs
10. generalized myofascial pain syndrome

Primary outcomes:
measure: change in shoulder range of motion
timeFrame: 12 weeks
Secondary outcomes:
measure: PROMIS score - upper extremity
timeFrame: 12 weeks
measure: DASH score
timeFrame: 12 weeks
measure: VAS score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Sports Medicine
state: California
Study officials:
affiliation: UC Davis Health
name: Kevin Mullins, MD
role: PRINCIPAL_INVESTIGATOR
References: