Telerehabilitation for Shoulder Arthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Revision procedures, tendon transfer, fracture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether telerehabilitation (remote physical therapy through video calls) matches the effectiveness of traditional in-person therapy for patients who have undergone shoulder surgery. It compares how well patients in both groups regain shoulder movement, manage pain, and perceive their recovery. Individuals who have had primary shoulder replacement surgery, either anatomic or reverse, without additional procedures, might be suitable for this trial. This research could provide more flexible recovery options, especially important when going out is challenging. As an unphased trial, it offers patients the chance to contribute to innovative recovery methods that could enhance future rehabilitation options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that telerehabilitation is safe for shoulder arthroplasty patients?

Research has shown that telerehabilitation provides a safe method for physical therapy after shoulder surgery. Studies have found that improvements in shoulder movement and patient satisfaction with telerehabilitation match those of in-person therapy. No major safety differences exist between the two methods.

In past studies, patients experienced no more negative side effects with telerehabilitation than with traditional therapy. This indicates that telerehabilitation is safe and well-tolerated for individuals recovering from shoulder surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telerehabilitation for shoulder arthritis because it offers a novel way to deliver physical therapy remotely, potentially making it more accessible and convenient for patients. Unlike traditional in-person therapy, telerehabilitation allows patients to conduct sessions via telemedicine with a physical therapist, reducing the need for frequent clinic visits. This method could be particularly beneficial for those with mobility issues or those living far from healthcare facilities. By using secure electronic medical records for these sessions, telerehabilitation ensures consistent and personalized care while still allowing for in-person visits to monitor progress at key intervals.

What evidence suggests that telerehabilitation is effective for shoulder arthritis?

This trial will compare telerehabilitation with traditional in-person physical therapy for shoulder arthritis recovery. Studies have shown that telerehabilitation, which participants in this trial may receive, can be as effective as in-person physical therapy for shoulder recovery. Research indicates that both telerehabilitation and traditional therapy lead to similar improvements in patients' perceptions of their progress and shoulder mobility after surgery. One study found that telerehabilitation can even surpass home exercises in improving shoulder function and quality of life. Overall, evidence suggests that telerehabilitation is a strong alternative for shoulder rehab after surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Brendan M Patterson, MD

Principal Investigator

University of Iowa

Olivia O'Reilly, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for patients scheduled for primary shoulder arthroplasty, either anatomic or reverse, by specific orthopedic surgeons. It's not open to those getting the surgery due to a fracture, unwilling participants, those having additional procedures like tendon transfers, or patients needing revision surgeries.

Inclusion Criteria

I am recommended for shoulder replacement surgery by a specialist.

Exclusion Criteria

I am scheduled for a corrective surgical procedure.

I am having additional procedures, like tendon transfer, alongside my main treatment.

I am having joint replacement surgery due to a fracture.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative Preparation

Participants are randomized into in-person or telerehabilitation groups and prepare for physical therapy

4 weeks

1 visit (in-person) at 2 weeks postoperative

Physical Therapy

Participants undergo either in-person physical therapy or telerehabilitation starting 6 weeks after surgery

6 months

5-6 visits (in-person) or multiple telehealth sessions

Follow-up

Participants are monitored for shoulder range of motion and patient-reported outcomes

24 months

Regular clinic visits at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Telerehabilitation

Trial Overview

The study tests telerehabilitation—physical therapy through online video conferencing—against traditional in-person physical therapy after shoulder arthroplasty. The goal is to compare outcomes such as range of motion, pain levels and patient-reported outcomes between the two methods.

How Is the Trial Designed?

Group I: Telerehabilitation Experimental Treatment 1 Intervention

Subjects who are randomized to telerehabilitation will be provided access to telemedicine visits with a physical therapist. Patients will have one in-person physical therapy visit before starting telerehabilitation, and another in-person visit at 3 months to assess progress. Telerehabilitation visits will be performed via secure usage of the electronic medical record (EMR). To ensure uniformity, and to allow for appropriate access to telehealth services, all telehealth visits will be carried out through the study institution's Department of Physical Therapy. It is expected most patients will complete formal physical therapy by 6 months postoperative measured by the time at which patient's regain functional range of motion or patients are satisfied with their results. Shoulder range of motion will be measured with a goniometer preoperatively, as well as 3,6, 12, and 24 months postoperatively at their regularly scheduled clinic visit.

Group II: Traditional In-Person Physical Therapy Active Control 1 Intervention

Subjects who are randomized to in-person therapy will present to a physical therapist of their choice with a established written protocol. The therapy protocol is developed in conjunction with the Department of Orthopaedic Surgery and the Department of Physical Therapy. Subjects are recommended to attend in-person appointments at least once a week as well as perform home exercises. Progress with therapy will be collected with weekly phone calls from the research team. It is expected most subjects will complete formal physical therapy by 6 months postoperative attending on average 5-6 visits, measured by the time at which patient's regain functional range of motion or are instructed by their therapist to discontinue. Shoulder range of motion will be measured with a goniometer preoperatively, as well as 3,6, 12, and 24 months postoperatively at their regularly scheduled clinic visit.

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Olivia C. O'Reilly

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

A systematic review of six randomized controlled trials involving 368 patients found that telerehabilitation for shoulder pain shows no significant difference in effectiveness compared to in-person physical therapy or home-based exercise programs.

However, telerehabilitation was found to be more effective than providing advice alone, significantly improving both shoulder pain and disability, although the overall evidence quality was very low to low, indicating caution in making strong recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy given by telerehabilitation on pain and disability of individuals with shoulder pain: A systematic review. Gava, V., Ribeiro, LP., Barreto, RPG., et al.[2022]

Biologic Therapy (BT) in rheumatic patients showed a higher incidence of adverse events, with an annual rate of 178 per 1000 BT patients compared to 1009 per 1000 in the control group, indicating a 1.6 times greater risk of adverse events associated with BT.

Despite the increased risk of infections and adverse events, the mortality rate for patients using BT was not higher than expected for the general population of the same age and gender, suggesting that while BT carries risks, it does not lead to increased mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient survival and safety with biologic therapy. Results of the Mexican National Registry Biobadamex 1.0. Ventura-Ríos, L., Bañuelos-Ramírez, D., Hernández-Quiroz, Mdel C., et al.[2019]

A study involving 34 patients with rheumatic and musculoskeletal diseases identified up to 171 important items related to safety and harms that patients experience during clinical trials.

The OMERACT community largely agreed (96%) that there is sufficient qualitative data to proceed with developing a Delphi survey to better understand and measure patient-reported safety and harm in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group. Berthelsen, DB., Simon, LS., Ioannidis, JPA., et al.[2023]

This pilot study involving patients who underwent thumb carpometacarpal arthroplasty and reverse shoulder arthroplasty showed that telerehabilitation is feasible and can maintain patient satisfaction, with no significant differences in recovery outcomes compared to traditional in-person therapy.

Patients in the telerehabilitation group reported high satisfaction levels, suggesting that this approach could effectively support upper extremity recovery while potentially reducing costs and improving access to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, effectiveness and patient satisfaction of telerehabilitation after thumb carpometacarpal arthroplasty and reverse total shoulder arthroplasty: A pilot study. Palm, KB., Blazar, PE., Manna, JC., et al.[2023]

In a study of 872 patients treated with biologic agents for inflammatory arthritis, 86.3% did not experience any adverse events (AEs), indicating a generally favorable safety profile for these medications.

While 16.4% of patients reported AEs, serious adverse events (SAEs) were rare, occurring in only 1.8% of patients, suggesting that the benefits of biologics in managing inflammatory arthritis outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Safety Profile of Biologics Used in Rheumatology: A Six-Year Observational Pharmacovigilance Study in the Calabria Region. Gagliardi, A., Iaquinta, FS., Grembiale, RD., et al.[2022]

A study of 100 rheumatoid arthritis patients revealed that many are hesitant to accept the risks of adverse effects from arthritis medications, with 45% unwilling to accept the risk of major toxicity.

Patients who had previously experienced adverse effects were more willing to accept risks associated with cosmetic changes, temporary discomfort, and major toxicity, indicating that past experiences can influence their risk tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unwillingness of rheumatoid arthritis patients to risk adverse effects. Fraenkel, L., Bogardus, S., Concato, J., et al.[2019]

A study involving 604 users of a digital medical device (DMD) for home-based rehabilitation after knee injuries showed that users had significantly higher adherence to their rehabilitation program (86%) compared to a control group (74%), indicating that the DMD effectively supports patient engagement.

The DMD not only improved adherence but also allowed users to perform rehabilitation exercises with greater intensity, contributing to clinically expected improvements in rehabilitation outcomes without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensor-based telerehabilitation system increases patient adherence after knee surgery. Höher, J., Lischke, B., Petersen, W., et al.[2023]

Citations

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Telerehabilitation After Shoulder Arthroplasty

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Rehabilitation for Shoulder Osteoarthritis (RTSA Trial)

Rehabilitation, including physical and occupational therapy, is generally considered safe for shoulder osteoarthritis and other conditions, as it is a common ...

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