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

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding an extra step during shoulder surgery, called pectoralis minor release (or pectoralis minor tenotomy), can reduce pain and improve movement for individuals undergoing Reverse Shoulder Arthroplasty (RSA). RSA is a type of shoulder replacement surgery, and researchers aim to determine if releasing a small chest muscle during the procedure affects recovery. Participants will be randomly assigned to receive RSA with or without this muscle release. This trial may suit patients scheduled for RSA who can give consent and are not undergoing surgery due to a bone fracture. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially enhance surgical outcomes for future patients.

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.

What prior data suggests that pectoralis minor release is safe for shoulder surgery?

Research has shown that a procedure called pectoralis minor release, which involves cutting a small chest muscle to relieve tension, has been safely performed during shoulder surgeries. In one study with 13 patients, combining this procedure with another shoulder surgery improved shoulder pain and function, with no major problems reported. In another case, a patient with shoulder pain and weakness after surgery experienced relief following the pectoralis minor release.

Overall, these findings suggest that cutting the pectoralis minor muscle is generally well-tolerated. Patients in previous studies reported better outcomes without significant side effects. This provides some confidence in the safety of the treatment under study in the current trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pectoralis minor release technique in shoulder surgery because it offers a potential improvement over standard shoulder procedures. Traditional treatments for shoulder issues, like reverse shoulder arthroplasty (RSA), often focus on addressing the primary mechanical dysfunction without releasing the pectoralis minor muscle. The unique aspect of this technique is that it targets the tightness and restriction of the pectoralis minor, which may lead to better shoulder mobility and pain relief. By releasing this specific muscle, the procedure might reduce complications and enhance recovery compared to conventional methods, providing a fresh approach to shoulder surgery.

What evidence suggests that releasing the pectoralis minor could improve outcomes after shoulder surgery?

This trial will compare shoulder surgery with and without the pectoralis minor release. Research has shown that releasing the pectoralis minor muscle during shoulder surgery can greatly reduce pain and improve shoulder movement. One study found that patients experienced complete pain relief and better movement after this procedure. Another study noted improvements in shoulder movement and a decrease in nerve-related symptoms for certain conditions. These findings suggest that including pectoralis minor release in shoulder surgery could help patients by reducing pain and improving mobility. ^{1 2 5 6 7}

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

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37146169/

Arthroscopic Pectoralis Minor Release After Reverse ... This ultimately led to complete pain relief and improved function. By sharing this case, we aim to shed light on this overlooked pathology ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666638324000264

Pectoralis major tendon transfer in reverse total shoulder ... This study included 13 patients with an average of 65.5 years (range, 52-82 years). All patients underwent a lateralized RTSA with concurrent PM transfer, ...

3. ovid.com ovid.com/journals/cacon/pdf/10.2106/jbjs.cc.22.00804~arthroscopic-pectoralis-minor-release-after-reverse-shoulder

Arthroscopic Pectoralis Minor Release After Reverse ... Early effectiveness of isolated pectoralis minor tenotomy in selected patients with neurogenic thoracic outlet syndrome. J Vasc Surg. 2013 ...

4. withpower.com withpower.com/trial/phase-advanced-glenohumeral-osteoarthritis-2-2024-77abb

Pectoralis Minor Release for Shoulder Surgery The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty ( ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0326815

Validation of the human disharmony loop: Pectoralis minor ... Outcomes included pain scores, clinical neuropathic lesions, rotator cuff impingement signs, shoulder range of motion, and complications. Results. 115 patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11896109/

Arthroscopic Pectoralis Minor Release and Infraclavicular ... Satisfaction and Derkash scores among patients undergoing endoscopic surgery were comparable with previously published studies on open FRR and scalenectomy, ...

7. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(24)00797-7/fulltext

Arthroscopically Assisted Pectoralis Minor Transfer for ... Arthroscopically assisted pectoralis minor transfer led to significant improvement in overall shoulder pain and function.