Physical Therapy vs Home Exercise for Shoulder Arthritis

Recruiting at 6 trial locations

Overseen By Amanda J Naylor, MA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Non-reverse arthroplasty, Cognitive deficits, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to compare outcomes between formal clinic based physical therapy (PT) rehabilitation and surgeon directed home therapy (HT) after reverse total shoulder arthroplasty (RSA) as measured by pain, range of motion, Single Assessment Numerical Evaluation (SANE), and American Shoulder and Elbow Surgery (ASES) scores at 6 weeks, 3, 6, 12, and 24 months postoperatively. The secondary objective of this study is to determine if PT rehabilitation following RSA is associated with a higher level of postoperative complications, specifically acromial stress fractures or dislocation. This information will be useful to discern if PT is effective in providing pain relief more quickly, as well as improved motion and self-reported functional outcomes following RSA, which can assist surgeons and rehabilitation specialists in designing optimal care plans for this patient population. The project will also help to clarify if PT services place patients who have RSA at higher risk for acromial stress fractures or dislocation.

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 this treatment for shoulder arthritis?

Research shows that both home-based exercise programs and supervised physical therapy can effectively improve shoulder pain, range of motion, and function. Studies have found that home-based programs, including web-based ones, can be as successful as traditional physical therapy in achieving these outcomes. ^{1 2 3 4 5}

Is home-based physical therapy safe for humans?

Research shows that home-based physical therapy programs, like PREHAB, are generally safe for humans, including older adults, when properly implemented. ^{3 6 7 8 9}

How does the treatment for shoulder arthritis differ from other treatments?

This treatment is unique because it offers a home-based or internet-based physical therapy option, which can be guided by a physician remotely, making it more accessible and potentially more cost-effective compared to traditional in-person physical therapy sessions. ^{2 7 10 11 12}

Research Team

Grant E Garrigues, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

This trial is for individuals who have undergone reverse total shoulder arthroplasty (RSA) due to cuff tear arthropathy, massive irreparable rotator cuff tears, or primary osteoarthritis. Participants must be able to speak, read, and write English without cognitive deficits that limit following directions. They should not require skilled nursing facilities or in-patient rehab post-surgery.

Inclusion Criteria

I am having shoulder replacement for specific shoulder issues.

Exclusion Criteria

I have difficulty understanding or following instructions due to cognitive issues.

I cannot go to physical therapy due to transportation or money issues.

Subjects who cannot speak, read, or write the English language

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo reverse total shoulder arthroplasty and initial recovery

1-2 weeks

Rehabilitation

Participants engage in either home therapy or formal physical therapy to improve motion and function

6 weeks

Varies by group: Home therapy or regular PT visits

Follow-up

Participants are monitored for safety, effectiveness, and complications such as acromial stress fractures and dislocations

up to 2 years

Regular follow-up visits and assessments

Treatment Details

Interventions

• Home Therapy
• Physical Therapy

Trial Overview The study compares formal clinic-based physical therapy (PT) with surgeon-directed home therapy (HT) after RSA. It measures pain relief, range of motion, and functional outcomes using specific scores over a period up to 24 months postoperatively. The risk of complications like acromial stress fractures or dislocation is also assessed.

Participant Groups

Group I: Physical Therapy (PT) Group Experimental Treatment 1 Intervention

Subjects will attend formal physical therapy after surgery.

Group II: Home Therapy (HT) Group Active Control 1 Intervention

Subjects will receive instruction from clinical staff regarding home therapy exercises after surgery.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Orthopedic Research and Education Foundation

Collaborator

Trials

23

Recruited

6,200+

Findings from Research

In a survey of 80 patients who underwent shoulder surgery, 65% reported that their physical therapy sessions contributed to their recovery, attending an average of 16.3 sessions, which highlights the perceived efficacy of traditional in-person physical therapy.

Despite the potential for alternatives like internet-based physical therapy (IBPT), 68.6% of patients expressed reluctance to consider IBPT, indicating a strong preference for in-person therapy and the importance of therapist engagement in the recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' perception of physical therapy after shoulder surgery. Sabesan, VJ., Dawoud, M., Stephens, BJ., et al.[2022]

Only one study out of 506 reviewed provided moderate evidence that early physical therapy after total shoulder arthroplasty can lead to quicker improvements in function and pain relief.

There is a significant gap in research regarding the effectiveness of physical therapy for reverse total shoulder arthroplasty, highlighting the need for more high-quality studies to guide rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of formal physical therapy following total shoulder arthroplasty: A systematic review. Edwards, PK., Ebert, JR., Littlewood, C., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Motions and functional performance after supervised physical therapy program versus home-based program after arthroscopic anterior shoulder stabilization: a randomized clinical trial. [2014]

2. Iran pubmed.ncbi.nlm.nih.gov

Successful Outcomes Achieved Via Web-based, Home Program after Total Shoulder Arthroplasty. [2022]

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

Effects on shoulder pain and disability of teaching patients with shoulder pain a home-based exercise program: a randomized controlled trial. [2022]

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

Agreement between patient-based and clinician-based assessment of the shoulder. [2019]

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

Protocol for a multicenter, randomised controlled trial of surgeon-directed home therapy vs. outpatient rehabilitation by physical therapists for reverse total shoulder arthroplasty: the SHORT trial. [2021]

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

AN ELASTIC EXERCISE BAND MOUNTED WITH A BANDCIZER™ CAN DIFFERENTIATE BETWEEN COMMONLY PRESCRIBED HOME EXERCISES FOR THE SHOULDER. [2022]

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

The new role of physical therapy in home care. [2019]

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

A prehabilitation program for physically frail community-living older persons. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

Health-Enabling Technologies for Telerehabilitation of the Shoulder: A Feasibility and User Acceptance Study. [2021]

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

Patients' perception of physical therapy after shoulder surgery. [2022]

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

Effectiveness of formal physical therapy following total shoulder arthroplasty: A systematic review. [2022]

12. England pubmed.ncbi.nlm.nih.gov

AGT-Reha-WK study: protocol for a non-inferiority trial comparing the efficacy and costs of home-based telerehabilitation for shoulder diseases with medical exercise therapy. [2022]