NCT04413162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2025

Completed
Last Updated

April 3, 2025

Status Verified

November 1, 2024

Enrollment Period

4.7 years

First QC Date

May 29, 2020

Last Update Submit

April 1, 2025

Conditions

Keywords

adhesive capsulitisfrozen shouldershoulder painrange of motioncapsular distentioncapsular distension

Outcome Measures

Primary Outcomes (1)

  • change in shoulder range of motion

    measured in degrees (high number of degrees = better range of motion)

    12 weeks

Secondary Outcomes (3)

  • PROMIS score - upper extremity

    12 weeks

  • DASH score

    12 weeks

  • VAS score

    12 weeks

Study Arms (1)

measurement before and after capsular distention

OTHER
Other: Kinect motion tracking system

Interventions

Kinect motion tracking system is used to measure shoulder range of motion compared to goniometric measurement.

measurement before and after capsular distention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Sports Medicine

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Conditions

BursitisShoulder PainMobility Limitation

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin Mullins, MD

    UC Davis Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 2, 2020

Study Start

June 10, 2020

Primary Completion

February 7, 2025

Study Completion

February 7, 2025

Last Updated

April 3, 2025

Record last verified: 2024-11

Locations