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

93 Participants Needed

Trial Summary

What is the purpose of this trial?

The use of reverse total shoulder arthroplasty (RSA) has increased dramatically in the United States in recent years. The importance of postoperative physical therapy in the setting of anatomic total shoulder is well understood and explored in the literature. The literature describing postoperative physical therapy for RSA, however, is scarce and somewhat limited to the field of physiatry in the form of clinical commentary on rehabilitation programs.In addition, the use of formal in-person therapy versus physician-guided home therapy has been explored in total shoulder arthroplasty, demonstrating similar post-operative range of motion and patient-reported outcome (PROs) between groups. Furthermore, previous research into "telerehabilitation" or remote physical therapy through a video-based platform has demonstrated noninferiority in outcomes in multiple orthopedic procedures, including hip and knee arthroplasty and reverse shoulder arthroplasty. Telehealth therapy has not yet been formally evaluated in a randomized approach for reverse or anatomic total shoulder arthroplasty. Given the ongoing COVID-19 pandemic, emphasis on social distancing, and multiple states having issued "stay at home" orders, a study into the effectiveness of telerehabilitation on current postoperative outcomes in shoulder arthroplasty may influence postoperative management and allow patients an alternative route for rehabilitation that allows more flexibility in completing, as well as limits potentially extraneous travel and exposure. The project will be a randomized control trial evaluating formal in-person physical therapy versus telerehabilitation after shoulder arthroplasty. Patients who undergo shoulder arthroplasty will complete either formal physical therapy or telerehabilitation postoperatively. The aim will be to identify any differences in shoulder range of motion, pain, or patient-reported outcome measures (PROs) between those who complete in-person physical therapy versus telerehabilitation therapy.

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 data supports the effectiveness of the treatment Telerehabilitation for Shoulder Arthritis?

Research shows that telerehabilitation, which involves doing physical therapy exercises remotely, is as effective as traditional in-person therapy for improving shoulder function and reducing pain after shoulder surgery. This suggests it could be a helpful treatment for shoulder arthritis as well. ^{1 2 3 4 5}

Is telerehabilitation for shoulder arthritis safe?

There is no specific safety data available for telerehabilitation in shoulder arthritis from the provided research articles. ^{6 7 8 9 10}

How is telerehabilitation different from other treatments for shoulder arthritis?

Telerehabilitation is unique because it allows patients to receive physical therapy remotely, using technology to guide exercises and monitor progress, which can improve access to care and reduce costs compared to traditional in-person therapy. This approach is particularly beneficial for those who have difficulty traveling to appointments, and studies suggest it is as effective as face-to-face therapy for improving shoulder function. ^{1 3 11 12 13}

Research Team

Olivia O'Reilly, MD

Principal Investigator

University of Iowa

Brendan M Patterson, MD

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy given by telerehabilitation on pain and disability of individuals with shoulder pain: A systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Sensor-based telerehabilitation system increases patient adherence after knee surgery. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Telerehabilitation after arthroscopic subacromial decompression is effective and not inferior to standard practice: Preliminary results. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Feasibility, effectiveness and patient satisfaction of telerehabilitation after thumb carpometacarpal arthroplasty and reverse total shoulder arthroplasty: A pilot study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Unwillingness of rheumatoid arthritis patients to risk adverse effects. [2019]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Tolerability of Apremilast Versus Placebo in Psoriatic Arthritis: A Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

Patient survival and safety with biologic therapy. Results of the Mexican National Registry Biobadamex 1.0. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Safety Profile of Biologics Used in Rheumatology: A Six-Year Observational Pharmacovigilance Study in the Calabria Region. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Real-Time Telerehabilitation in Older Adults With Musculoskeletal Conditions: Systematic Review and Meta-analysis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Telerehabilitation in the Treatment of Frozen Shoulder: A Case Report. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

A description of the barriers, facilitators, and experiences of hand therapists in providing remote (tele) rehabilitation: An interpretive description approach. [2023]