Adhesive CapsulitisNCT04413162
Using Kinect Motion Capture to Measure Shoulder Motion in Patients Undergoing Capsular Distension for Adhesive Capsulitis
A study testing Kinect motion tracking system in people with Adhesive Capsulitis and Adhesive Capsulitis of Shoulder, run by University of California, Davis at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis, Adhesive Capsulitis of Shoulder, Frozen Shoulder
- What is being tested?
- Kinect motion tracking system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to 7 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- inability to provide informed consent
- symptomatic glenohumeral or acromioclavicular pathology
- referred pain from the neck or internal organs
- generalized myofascial pain syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Sports Medicine
Sacramento, California, 95816
About this study
Official title: Measurement of Shoulder Range of Motion Using Microsoft Kinect 2.0 in Patients Undergoing Ultrasound-guided Capsular Distension for Adhesive Capsulitis
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.
Read the 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.
- Conditions
- Adhesive Capsulitis, Adhesive Capsulitis of Shoulder, Frozen Shoulder, Shoulder Frozen, Shoulder Pain, Mobility Limitation
- Being tested
- Kinect motion tracking system
- Keywords
- adhesive capsulitis, frozen shoulder, shoulder pain, range of motion, capsular distention, capsular distension
- Medical subject headings
- Bursitis, Shoulder Pain, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinect motion tracking systemOther
Kinect motion tracking system is used to measure shoulder range of motion compared to goniometric measurement.
| Study group | Role | What they receive |
|---|---|---|
| measurement before and after capsular distention | Other | Not described Receives: Other: Kinect motion tracking system |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in shoulder range of motion
measured in degrees (high number of degrees = better range of motion)
Measured: 12 weeks
Secondary outcomes (3)
PROMIS score - upper extremity
Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated, 46-item, self-reported system to assess physical function and symptoms in patients with disorders of the limb. Range of possible values: 46-230. (Higher score indicates higher function and outcomes)
Measured: 12 weeks
DASH score
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 38-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. Range of possible values: 38-150. (Lower score indicates better function / less disability)
Measured: 12 weeks
VAS score
Visual analog scale is a validated, subjective measure for pain. Range of possible values: 0-10. (Higher score indicates more pain)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start10 Jun 2020
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Mullins, MD, Principal investigator, UC Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413162
- Sponsor's protocol ID
- 1490166
- Status last verified
- Nov 2024
- First submitted
- 29 May 2020
- Last updated
- 3 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Shoulder Range of Motion Using Microsoft Kinect 2.0 in Patients Undergoing Ultrasound-guided Capsular Distension for Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT04413162
- Acronym / sponsor ID
- 1490166
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measurement before and after capsular distention | Other | Other: Kinect motion tracking system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinect motion tracking systemKinect motion tracking system is used to measure shoulder range of motion compared to goniometric measurement. | Other | measurement before and after capsular distention |
Primary outcome
change in shoulder range of motion
Time frame: 12 weeks
measured in degrees (high number of degrees = better range of motion)
3 secondary outcomes
PROMIS score - upper extremity
Time frame: 12 weeks
DASH score
Time frame: 12 weeks
VAS score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Learn more or sign up for the study here!Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Mullins, MD principal investigator
UC Davis Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinect motion tracking system in people with Adhesive Capsulitis and Adhesive Capsulitis of Shoulder, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in shoulder range of motion (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.