Physical Therapy for Broken Humerus

Overseen By Lori Elder

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Previous rTSA, Elective rTSA, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal timing for starting physical therapy after surgery for a broken shoulder bone, specifically following reverse total shoulder arthroplasty (rTSA). The researchers aim to determine whether beginning physical therapy earlier (at 2 weeks) or later (at 6 weeks) results in better recovery and fewer complications for individuals undergoing this surgery due to fractures. The focus is on enhancing the ability to perform daily activities and effectively manage pain. The trial seeks participants aged 50-85 who have recently undergone rTSA for a shoulder fracture. As an unphased trial, it offers participants the chance to contribute to valuable insights that could improve post-surgery recovery strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that early postoperative physical therapy is safe for patients undergoing reverse total shoulder arthroplasty?

Research has shown that starting physical therapy soon after a humerus fracture is generally safe. Some studies have found that early therapy can speed up healing and reduce future complications. Those who begin early often recover more quickly and face fewer issues later.

Evidence also indicates that waiting longer to start physical therapy is safe. Studies suggest that delaying therapy does not increase risks, and both early and delayed therapy are well-tolerated by patients.

In summary, both early and delayed physical therapy are safe options. Early therapy might accelerate recovery, but both choices are generally safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the timing of physical therapy after a broken humerus, which could transform recovery protocols. Currently, physical therapy usually starts around six weeks post-surgery. This trial examines whether starting therapy as early as two weeks post-surgery could enhance healing and improve outcomes. If successful, it could lead to faster recovery times and better arm function, offering a significant improvement over the traditional approach.

What evidence suggests that early postoperative physical therapy is effective for proximal humerus fractures?

This trial will compare two approaches to physical therapy for patients with a broken humerus. Research has shown that starting physical therapy soon after surgery can help patients with upper arm fractures recover faster and experience fewer complications. Participants in the "Early Onset Physical Therapy" arm will begin therapy at 2 weeks post-surgery, potentially leading to quicker healing, fewer issues, and reduced healthcare costs. Meanwhile, those in the "Delayed Onset Physical Therapy" arm will start therapy at 6 weeks post-surgery, which can also improve movement and pain relief over time. Some studies have found no major difference in results between starting therapy early or later in cases where surgery isn't needed. Both options offer benefits, but early therapy might lead to feeling better sooner. ^{2 3 4 6 7}

Who Is on the Research Team?

Seth Yarboro, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for elderly patients who have had a reverse total shoulder arthroplasty (rTSA) due to a proximal humerus fracture. It's designed to help those struggling with pain and limited shoulder movement after their injury.

Inclusion Criteria

I am between 50-85 years old and having shoulder replacement surgery for a shoulder fracture.

Exclusion Criteria

Prisoners

I am scheduled for elective reverse shoulder replacement surgery.

I have had a reverse shoulder replacement on the same side.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reverse total shoulder arthroplasty (rTSA) followed by either early or delayed rehabilitation

6 months

In-person clinic visits and radiographs at 6 weeks, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

In-person clinic visits and radiographs at 6 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy

Trial Overview

The study is testing the safety and effectiveness of starting physical therapy early after surgery versus delaying it. The goal is to find the best timing for rehab that improves patient outcomes and minimizes complications.

How Is the Trial Designed?

Group I: Early Onset Physical Therapy Active Control 1 Intervention

Patients in this arm will begin post operative physical therapy at 2 weeks after procedure.

Group II: Delayed Onset Physical Therapy Active Control 1 Intervention

Patients in this arm will begin post operative physical therapy at 6 weeks after procedure.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Foundation of Orthopedic Trauma

Collaborator

Trials

4

Recruited

530+

Published Research Related to This Trial

In a 10-year study involving 12,976 patients at a university health center, direct access to physical therapy (PT) showed no reported serious medical issues or adverse events, indicating a high level of safety for patients.

The study concluded that patients receiving care through direct access to PT are at minimal to no risk for negligent care, suggesting that this practice can be safely implemented in similar healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct Access to Physical Therapy Services Is Safe in a University Student Health Center Setting. Mintken, PE., Pascoe, SC., Barsch, AK., et al.[2018]

In a study of 361 patients undergoing physical therapy for shoulder disorders, higher initial disability and therapist predictions of restricted activities were linked to greater disability at discharge.

Factors such as shoulder surgery, higher pain intensity, and younger age were associated with greater improvement in disability, highlighting the complexity of recovery outcomes in shoulder therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognosis in soft tissue disorders of the shoulder: predicting both change in disability and level of disability after treatment. Kennedy, CA., Manno, M., Hogg-Johnson, S., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00438633

Comparison of Early and Late Therapy for Adults With Non- ...

Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11866563/

Early versus delayed mobilisation for non-surgically treated ...

Primary outcomes were patient-reported function and pain at short-term (3 months), mid-term (6 months) and long-term (12 months) follow-up, and ...

3.

withpower.com

withpower.com/trial/phase-fractures-bone-3-2025-84f3a

Physical Therapy for Broken Humerus

This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10697187/

Nonoperatively Treated Proximal Humerus Fractures

Conclusion: Delaying exercises for a month does not affect recovery from nonoperative treatment of a fracture of the proximal humerus. People can choose ...

5.

jospt.org

jospt.org/doi/10.2519/josptopen.2025.0135

The Effect of Early Physical Therapy Intervention on Case ...

RESULTS: Initiating PT early (0-2 days) was associated with significantly shorter case durations and fewer PT visits across all diagnostic ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06869343

Early Versus Delayed Rehabilitation After Reverse Total ...

This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9211385/

Interventions for treating proximal humeral fractures in adults

Non‐surgical treatment usually involves a period of immobilisation, such as in an arm sling, for one week or usually longer. This is followed by physiotherapy ...