Pectoralis Minor Release for Shoulder Surgery

Recruiting at 1 trial location

Overseen By Musab Gulzar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Revision arthroplasty, Proximal humerus fractures, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Surgery and immediate postoperative period

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty (RSA). The main questions it aims to answer are: * whether releasing the pectoralis minor prophylactically could have better pain relief * whether releasing the pectoralis minor prophylactically could have increased Range of motion (ROM) outcomes * whether releasing the pectoralis minor prophylactically could have higher final Patient Reported Outcome Measurements (PROMs) Participants will be randomized to either undergo RSA with pectoralis minor release or RSA without pectoralis minor release.

Do I need to stop my current medications for this trial?

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.

How does the pectoralis minor release treatment differ from other treatments for shoulder issues?

Pectoralis minor release is unique because it involves surgically releasing the pectoralis minor tendon to improve shoulder motion and alleviate pain, particularly in cases where non-surgical treatments like stretching and strengthening have failed. This approach specifically targets the muscle's attachment to the scapula, which can help correct shoulder mechanics and reduce symptoms associated with scapular dyskinesis. ^{1 2 3 4 5}

Who Is on the Research Team?

Eric Wagner, MD, MS

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals with shoulder arthritis, rotator cuff tears, or cuff tear arthropathy who are planning to undergo Reverse Total Shoulder Arthroplasty (RSA). Specific eligibility criteria details were not provided.

Inclusion Criteria

I am having surgery for a specific shoulder replacement.

I am willing and able to agree to participate in the study.

Exclusion Criteria

Prisoners

Pregnant women

I am unable to give consent for myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Reverse Shoulder Arthroplasty (RSA) with or without pectoralis minor release

Surgery and immediate postoperative period

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of Scapulohumeral Rhythm, Subjective Shoulder Value, and Range of Motion

1 year

Follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Pectoralis Minor Release

Trial Overview The study is testing whether doing an additional procedure called pectoralis minor release during RSA surgery can improve pain relief, increase range of motion, and result in better patient-reported outcomes. Participants will be randomly assigned to have RSA with or without the pectoralis minor release.

How Is the Trial Designed?

Group I: RSA with pectoralis minor release Experimental Treatment 2 Interventions

Group II: RSA without pectoralis minor release Active Control 1 Intervention

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Endoscopic release of the pectoralis minor tendon significantly improves symptoms of pectoralis minor syndrome, with most patients experiencing substantial pain relief and improved shoulder function after surgery.

In a study of 10 patients, the procedure resulted in a decrease in pain from a median VAS score of 8.5 preoperatively to 1 at follow-up, with no reported surgical complications, indicating both efficacy and safety of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic release of the pectoralis minor tendon from the coracoid for pectoralis minor syndrome. Haeni, D., Martinez-Catalan, N., Esper, RN., et al.[2022]

The Pectoralis Minor Length (PML) test showed excellent reliability in measuring shoulder mechanics, but the change in measurements after PM tenotomy was small and not significant enough to support the current threshold of 2.6 cm for identifying PM shortening.

The study suggests that the Pectoralis Minor's influence on shoulder mechanics, particularly scapular posterior tilt, may be less significant than previously thought, indicating that other factors contribute more to measurement variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the pectoralis minor length test: A novel approach. Weber, C., Enzler, M., Wieser, K., et al.[2022]

The pectoralis minor (PM) plays a significant role in scapular movement and is linked to shoulder pain, especially in athletes with scapular dyskinesis, highlighting its importance in shoulder rehabilitation.

Recent studies indicate that surgical release of the PM can improve shoulder motion and outcomes in patients who do not respond to nonoperative treatments, suggesting it as a viable option for those with persistent issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic Pectoralis Minor Release. Hendrix, ST., Hoyle, M., Tokish, JM.[2020]

A study involving 21 physically active college students found that self-myofascial release with movement significantly improved shoulder flexion range of motion and increased the length of the pectoralis minor muscle compared to a placebo technique.

While the self-mobilization technique showed benefits for shoulder motion and muscle length, the change in forward scapular posture may not be clinically significant, indicating that while effective, the technique's impact on posture should be interpreted with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of Pectoralis Minor Self-Mobilization on Shoulder Motion and Posture: A Blinded and Randomized Placebo-Controlled Study in Asymptomatic Individuals. Laudner, K., Thorson, K.[2021]

A dedicated physical therapy and stretching program successfully resolved pectoralis minor tightness and associated shoulder symptoms in 87% of the 46 patients studied, demonstrating the efficacy of nonoperative treatment.

For the 6 patients who did not respond to therapy and underwent surgical release of the pectoralis minor tendon, significant improvements in shoulder function and pain were observed, with no reported complications, indicating that surgery can be a safe and effective option for refractory cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Release of the Pectoralis Minor Tendon for Scapular Dyskinesia and Shoulder Pain. Provencher, MT., Kirby, H., McDonald, LS., et al.[2019]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Arthroscopic release of the pectoralis minor tendon from the coracoid for pectoralis minor syndrome. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Validation of the pectoralis minor length test: A novel approach. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Pectoralis Minor Release. [2020]

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

Acute Effects of Pectoralis Minor Self-Mobilization on Shoulder Motion and Posture: A Blinded and Randomized Placebo-Controlled Study in Asymptomatic Individuals. [2021]

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

Surgical Release of the Pectoralis Minor Tendon for Scapular Dyskinesia and Shoulder Pain. [2019]