Frozen ShoulderNCT03883659
Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
A study testing Smartphone and traditional paper hangouts in people with Frozen Shoulder, run by National Yang Ming Chiao Tung University at 2 sites in Taiwan.
Trial summary
This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Smartphone and traditional paper hangouts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Apr 2019to 30 Jul 2019
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gradual shoulder pain and stiffness at least 4 months
- loss of active and passive shoulder mobility, shoulder external rotation <45 degree
- ability to use the smartphone
Who cannot join
- normal shoulder mobility
- diagnostic shoulder osteoarthritis
- nerve pain
- injection of corticosteroids in 3 months
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Tri-Service General Hospital
Taipei, Neihu District, 11490
Yang Ming university
Taipei
About this study
This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts.
Read the detailed description
This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts. The outcome measure including shoulder range of motion, pain condition, home exercise adherence and satisfaction of smartphone program
- Conditions
- Frozen Shoulder
- Being tested
- Smartphone, traditional paper hangouts
- Keywords
- frozen shoulder, smartphone, home exercise program, range of motion
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartphoneOther
patients with frozen shoulder in the smartphone group will use the smartphone to conduct the home exercise program. The patients will be asked to follow the description to have mobility assessment at least 1 week and do the individualized exercise themselves.
traditional paper hangoutsOther
patients with frozen shoulder in the smartphone group will use the paper hangouts to conduct the home exercise program. The content of the paper hangouts were description of the home exercise.
| Study group | Role | What they receive |
|---|---|---|
| traditional paper hangouts group | Active comparator | patients use the traditional paper hangouts to conduct the home exercise program at home Receives: Other: traditional paper hangouts |
| smartphone group | Experimental | patients use the smartphone to conduct the home exercise program at home Receives: Other: Smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
home exercise adherence
the days patients do the home exercise program
Measured: 4 weeks
Secondary outcomes (3)
shoulder range of motion
the mobility of shoulder
Measured: baseline, 4 weeks
Visual analog scale (VAS)
Ranged form 0 (minimum score) to 10 (Maximum score) ,the higher score represent more painful
Measured: baseline, 4 weeks
System usability scale (SUS)
the satisfaction scale of the smartphone program
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019
- Primary completion3 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Hsu Sung, National Yang Ming Chiao Tung University
- Investigators
- Wen-Hsu Sung, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883659
- Sponsor's protocol ID
- FStraining
- Status last verified
- Aug 2019
- First submitted
- 18 Mar 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT03883659
- Acronym / sponsor ID
- FStraining
- Conditions
- Frozen Shoulder
- Keywords
- frozen shoulder, smartphone, home exercise program, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 21 Mar 2019 (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 was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts.
Detailed description
This study was to investigate the reliability and validity of the smartphone goniometer app to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare the intervention effect and adherence to home exercise between the smartphone and traditional paper hangouts. The outcome measure including shoulder range of motion, pain condition, home exercise adherence and satisfaction of smartphone program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| traditional paper hangouts group | Active comparator | Other: traditional paper hangoutspatients use the traditional paper hangouts to conduct the home exercise program at home |
| smartphone group | Experimental | Other: Smartphonepatients use the smartphone to conduct the home exercise program at home |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- gradual shoulder pain and stiffness at least 4 months
- loss of active and passive shoulder mobility, shoulder external rotation <45 degree
- ability to use the smartphone
Key exclusion criteria (4 listed)
- normal shoulder mobility
- diagnostic shoulder osteoarthritis
- nerve pain
- injection of corticosteroids in 3 months
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 |
|---|---|---|
| Smartphonepatients with frozen shoulder in the smartphone group will use the smartphone to conduct the home exercise program. The patients will be asked to follow the description to have mobility assessment at least 1 week and do the individualized exercise themselves. | Other | smartphone group |
| traditional paper hangoutspatients with frozen shoulder in the smartphone group will use the paper hangouts to conduct the home exercise program. The content of the paper hangouts were description of the home exercise. | Other | traditional paper hangouts group |
Primary outcome
home exercise adherence
Time frame: 4 weeks
the days patients do the home exercise program
3 secondary outcomes
shoulder range of motion
Time frame: baseline, 4 weeks
Visual analog scale (VAS)
Time frame: baseline, 4 weeks
System usability scale (SUS)
Time frame: 4 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 22 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Frozen Shoulder
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
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Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
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OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
Recruiting
Maitland Mobilization With and Without Stroking Release Technique of Rotator Cuff Muscle in Frozen Shoulder
Adhesive Capsulitis
Not yet recruiting
Spencer's Technique Versus Mulligan's Technique for Stage II Frozen Shoulder
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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.
Wen-Hsu Sung, PhD principal investigator
Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone and traditional paper hangouts in people with Frozen Shoulder, run by National Yang Ming Chiao Tung University at 2 sites in Taiwan.
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 3 inclusion and 4 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 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
home exercise adherence (time frame: 4 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 22 Aug 2019.