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

Trial Summary

What is the purpose of this trial?

Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion. Evidence has shown that reverse total shoulder arthroplasty (rTSA) is an effective option to improve pain and function for patients with acute displaced proximal humerus fractures. Given that patients undergoing rTSA for proximal humerus fractures typically experience worse functional outcomes, worse patient-reported outcomes, and higher rates of complication compared to those with elective indications for surgical intervention, it is critical to determine a secure path to recovery for these patients after surgery. Early rehabilitation has been proposed to be safe and effective for patients who undergo rTSA for elective indications; however, there is a paucity of research evaluating safety and effectiveness of timing of rehabilitation for rTSA patients in the trauma setting. Currently, there exists a great variability in postoperative rehabilitation protocols across orthopaedic practices. This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of patients undergoing rTSA for proximal humerus fractures in order to provide more specific recommendations for this patient population.

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 data supports the effectiveness of the treatment Physical Therapy for a broken humerus?

Research shows that physical therapy, including self-training and follow-up assessments, helps patients with a broken humerus regain normal daily function within 8 weeks. Early active movements within pain limits can improve outcomes, and 81% of patients had satisfactory results with physiotherapy. ^{1 2 3 4 5}

Is physical therapy generally safe for humans?

Research indicates that direct access to physical therapy services is safe, as shown in a study conducted in a university health center setting, which found no increased risk of adverse events. ^{6 7 8 9 10}

How does physical therapy differ from other treatments for a broken humerus?

Physical therapy for a broken humerus focuses on remobilization and muscle strengthening after initial immobilization, which is crucial for improving joint motion and strength. Unlike surgical interventions, it emphasizes exercises and self-training to enhance recovery, potentially shortening the treatment period by two to four weeks. ^{1 2 5 11 12}

Research Team

Seth Yarboro, MD

Principal Investigator

University of Virginia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Fractures of the neck of the humerus: a review of the late results. [2019]

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

Serial assessment and treatment of a humeral fracture. [2008]

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

Lack of Benefit of Physical Therapy on Function Following Supracondylar Humeral Fracture: A Randomized Controlled Trial. [2021]

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

Prognosis in soft tissue disorders of the shoulder: predicting both change in disability and level of disability after treatment. [2022]

5. Sweden pubmed.ncbi.nlm.nih.gov

Physiotherapy after fracture of the proximal end of the humerus. Comparison between two methods. [2005]

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

Clinical databases in physical therapy. [2022]

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

Patterns of rehabilitation utilization after hip fracture in acute hospitals and skilled nursing facilities. [2019]

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

Medical history profile: orthopaedic physical therapy outpatients. [2016]

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

Direct Access to Physical Therapy Services Is Safe in a University Student Health Center Setting. [2018]

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

Evaluating Clinical Performance of Student Physical Therapists: A Comparison of Student- and Staff-Managed Patient Outcomes After Hip Arthroplasty. [2019]

11. Turkey pubmed.ncbi.nlm.nih.gov

Utilization of axillary brachial plexus block in the postoperative rehabilitation of intra-articular fractures of the distal humerus. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[Concept of functional therapy exemplified by fresh closed humeral fracture]. [2006]