Musculoskeletal DiseasesNCT07093164
Randomized Controlled Single-blind Non-inferiority Trial Comparing an Offer of Initial Virtual Visit and Usual Care
A study testing Virtual visit in people with Musculoskeletal Diseases, run by University of Texas at Austin.
Trial summary
This randomized controlled trial will address whether there is a difference in satisfaction with treatment plan, satisfaction with the clinician, perceived empathy, patient reported outcomes, and psychological measures among patients randomized to the offer of an initial virtual health or telehealth visit compared to… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Virtual visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Between 17 and 90 years old
- musculoskeletal problem
- New and returned
Who cannot join
- -
About this study
This randomized controlled trial will address whether there is a difference in satisfaction with treatment plan, satisfaction with the clinician, perceived empathy, patient reported outcomes, and psychological measures among patients randomized to the offer of an initial virtual health or telehealth visit compared to those provided an initial in person visit.
Read the detailed description
Virtual visits (video) provide people seeking care additional options. The quality of virtual care resources has improved, making it a user-friendly way to address health concerns. The benefits of virtual visits include no travel time, less time away from work, and no need for dependent care arrangements.
Previous studies found virtual visits to be safe, efficient and accurate for selected orthopaedic patients . An RCT found telemedicine capable of providing a satisfactory standard care in the management of minor injuries. Others suggest that virtual care is an alternative to in person visits for orthopaedic patients in an outpatient setting.
There are concerns that virtual care will represent another commodity that will increase the amount and costs of care without increasing health as was observed for retail care. On the other hand, there is evidence that online care for simple conditions saves money. Also a pilot study showed that online visits appeared to reduce medical costs for patients during a 6-month period after the visit.
This randomized controlled trial will address whether there is a difference in satisfaction with treatment plan, satisfaction with the clinician, perceived empathy, patient reported outcomes, and psychological measures among patients randomized to the offer of an initial virtual health or telehealth visit compared to those provided an initial in person visit.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Virtual visit
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual visitBehavioural
Patients will be provided an initial virtual health or telehealth visit instead of an in person visit.
| Study group | Role | What they receive |
|---|---|---|
| In person visit | No intervention | Patients will be provided an initial in person visit. Patients that visit in person will complete the REDCap survey after the visit. |
| Virtual visit | Experimental | Patients will be provided an initial virtual health or telehealth visit. At the end of the virtual visit, if patients decide to cancel the in person visit, they will be asked to complete a REDCap survey via text link. Receives: Behavioral: Virtual visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guttman Satisfaction scale
The Guttman Satisfaction Scale is a unidimensional questionnaire designed to measure the degree of patient satisfaction with the care they received. It consists of a series of hierarchically ordered yes/no items, with each successive item indicating a higher level of satisfaction. Total scores range from 0 to 7, with higher scores reflecting greater satisfaction, representing a better outcome.
Measured: At time of initial visit and again 1 month following visit
Secondary outcomes (4)
Jefferson scale of patient perception of physician empathy
The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with total scores ranging from 5 to 35. Higher scores indicate greater perceived physician empathy, representing a better outcome.
Measured: Once only - after initial visit
Patient Reported Outcome Measurement Information System(PROMIS) Upper extremity Physical Function Computer Adaptive Test
Patient physical function will be assessed using the PROMIS Upper Extremity Computer Adaptive Test (CAT). This instrument evaluates the ability to perform daily activities requiring upper limb function, such as reaching, lifting, and fine motor tasks. Scores are reported as T-scores, ranging from 20 (indicating minimum physical ability) to 80 (maximum physical ability). Higher scores reflect better upper extremity function and therefore a better outcome.
Measured: At time of initial visit and again 1 month following visit
Pain intensity scale
Pain intensity will be assessed using a numerical rating scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Higher scores reflect greater pain intensity and therefore a worse outcome.
Measured: At time of initial visit and again 1 month following visit
Number of diagnostic tests or treatments
Total number of all tests or treatments performed for patient, including: injections, imaging studies and procedures.
Measured: Cumulative total at 1 month following visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: Deemed infeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- . Patients will be randomized using a random number generator in Microsoft Excel in 1:1 ratio to a standard in person visit OR to be called by a research assistant to offer a virtual visit in advance of an in person visit. Patients that indicate interest in a virtual visit will make a scheduled video appointment and test the website to be used in conjunction with the research assistant. At the end of the virtual visit, if patients decide to cancel the in person visit, they will be asked to complete a REDCap survey via text link.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ring, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093164
- Sponsor's protocol ID
- 2019-11-0170
- Status last verified
- Jul 2025
- First submitted
- 1 Feb 2020
- Last updated
- 30 Jul 2025
- 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Single-blind Non-inferiority Trial Comparing an Offer of Initial Virtual Visit and Usual Care
- ClinicalTrials.gov ID
- NCT07093164
- Acronym / sponsor ID
- 2019-11-0170
- Conditions
- Musculoskeletal Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Deemed infeasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 30 Jul 2025 (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 randomized controlled trial will address whether there is a difference in satisfaction with treatment plan, satisfaction with the clinician, perceived empathy, patient reported outcomes, and psychological measures among patients randomized to the offer of an initial virtual health or telehealth visit compared to those provided an initial in person visit.
Detailed description
Virtual visits (video) provide people seeking care additional options. The quality of virtual care resources has improved, making it a user-friendly way to address health concerns. The benefits of virtual visits include no travel time, less time away from work, and no need for dependent care arrangements.
Previous studies found virtual visits to be safe, efficient and accurate for selected orthopaedic patients . An RCT found telemedicine capable of providing a satisfactory standard care in the management of minor injuries. Others suggest that virtual care is an alternative to in person visits for orthopaedic patients in an outpatient setting.
There are concerns that virtual care will represent another commodity that will increase the amount and costs of care without increasing health as was observed for retail care. On the other hand, there is evidence that online care for simple conditions saves money. Also a pilot study showed that online visits appeared to reduce medical costs for patients during a 6-month period after the visit.
This randomized controlled trial will address whether there is a difference in satisfaction with treatment plan, satisfaction with the clinician, perceived empathy, patient reported outcomes, and psychological measures among patients randomized to the offer of an initial virtual health or telehealth visit compared to those provided an initial in person visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- . Patients will be randomized using a random number generator in Microsoft Excel in 1:1 ratio to a standard in person visit OR to be called by a research assistant to offer a virtual visit in advance of an in person visit. Patients that indicate interest in a virtual visit will make a scheduled video appointment and test the website to be used in conjunction with the research assistant. At the end of the virtual visit, if patients decide to cancel the in person visit, they will be asked to complete a REDCap survey via text link.
| Arm | Type | Receives |
|---|---|---|
| In person visit | No intervention | –Patients will be provided an initial in person visit. Patients that visit in person will complete the REDCap survey after the visit. |
| Virtual visit | Experimental | Behavioral: Virtual visitPatients will be provided an initial virtual health or telehealth visit. At the end of the virtual visit, if patients decide to cancel the in person visit, they will be asked to complete a REDCap survey via text link. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Between 17 and 90 years old
- musculoskeletal problem
- New and returned
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Virtual visitPatients will be provided an initial virtual health or telehealth visit instead of an in person visit. | Behavioural | Virtual visit |
Primary outcome
Guttman Satisfaction scale
Time frame: At time of initial visit and again 1 month following visit
The Guttman Satisfaction Scale is a unidimensional questionnaire designed to measure the degree of patient satisfaction with the care they received. It consists of a series of hierarchically ordered yes/no items, with each successive item indicating a higher level of satisfaction. Total scores range from 0 to 7, with higher scores reflecting greater satisfaction, representing a better outcome.
4 secondary outcomes
Jefferson scale of patient perception of physician empathy
Time frame: Once only - after initial visit
Patient Reported Outcome Measurement Information System(PROMIS) Upper extremity Physical Function Computer Adaptive Test
Time frame: At time of initial visit and again 1 month following visit
Pain intensity scale
Time frame: At time of initial visit and again 1 month following visit
Number of diagnostic tests or treatments
Time frame: Cumulative total at 1 month following visit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual visit in people with Musculoskeletal Diseases, run by University of Texas at Austin.
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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Guttman Satisfaction scale (time frame: At time of initial visit and again 1 month following visit). 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 30 Jul 2025.