Surgery vs Non-Surgical Treatment for Rotator Cuff Tears

(ARC Trial)

No longer recruiting at 21 trial locations

Overseen By Mark Newman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Shoulder fracture, Previous surgery, Osteoarthritis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether surgery or physical therapy is more effective for treating rotator cuff tears. Rotator cuff tears often cause shoulder pain and limit movement, and the trial compares these two treatment options to determine which is more effective. Participants should have shoulder pain and an MRI-confirmed tear of 4cm or less and be medically fit for surgery. This study is important as it could guide treatment decisions for those suffering from rotator cuff tears. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could improve treatment options for future patients.

Do I need to stop my current medications for the 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that surgery for rotator cuff tears usually leads to good long-term results. One study found that surgery reduced the chance of needing additional surgery later by over 25%. Another study demonstrated that surgery resulted in fewer complications and improved shoulder movement compared to some other treatments.

Non-surgical options, such as physical therapy, are also popular. Physical therapy is effective, especially for less severe tears, and serves as a good choice for those wishing to avoid surgery.

Both surgery and physical therapy have their own advantages and disadvantages. Surgery might offer better long-term relief, while physical therapy is less invasive. These factors are important to consider when deciding on the best treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments for rotator cuff tears because they offer a direct comparison between surgical and non-surgical approaches. Traditional care often involves surgery followed by physical therapy, which can be invasive and requires a lengthy recovery. The non-operative treatment in this trial focuses solely on physical therapy, which could offer a less invasive alternative with fewer risks and quicker recovery times. This trial aims to clarify which method is more effective for patients, potentially changing how rotator cuff tears are treated in the future.

What evidence suggests that this trial's treatments could be effective for rotator cuff tears?

This trial compares surgical and non-surgical treatments for rotator cuff tears. Research has shown mixed results for treating these tears with either surgery or physical therapy. Participants in the operative arm will undergo surgery, which can repair the tear, but 20-94% of patients may experience a recurrence, leading to ongoing shoulder issues. Participants in the non-operative arm will receive physical therapy, which benefits about 75% of patients with non-injury-related tears, providing lasting relief for many. Both methods generally yield good results, but non-surgical treatments often lead to faster initial improvements. Each approach offers benefits, so treatment choice may depend on personal needs and the specific nature of the tear. ^{2 6 7 8 9}

Who Is on the Research Team?

Nitin Jain, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people aged 40 to under 85 with shoulder pain or limited movement due to a small rotator cuff tear, confirmed by MRI. They must be medically fit for surgery (ASA I-III) and able to consent. It's not for those with other primary diagnoses, severe trauma-caused tears, previous surgeries on the affected side, certain muscle-only tears, or contraindications to MRI.

Inclusion Criteria

Ability and willingness to provide informed consent

I am between 40 and 84 years old.

I have shoulder pain or can't move my shoulder well.

Exclusion Criteria

Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)

Glenohumeral osteoarthritis on xrays/MRI, as determined by recruiting MD

I had a shoulder fracture involving the humeral head in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either operative treatment with surgery and post-operative physical therapy or non-operative treatment with physical therapy

12 months

Follow-up

Participants are monitored for pain and function outcomes using SPADI and ASES measures

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Non-Operative
• Operative

Trial Overview The study compares two approaches for treating rotator cuff tears: surgical (operative) and non-surgical (non-operative). The goal is to determine which treatment provides better outcomes in terms of pain relief and improved shoulder function.

How Is the Trial Designed?

Group I: Operative Active Control 1 Intervention

surgery + post-operative physical therapy

Group II: Non-Operative Active Control 1 Intervention

non-operative physical therapy

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23540577/

Effectiveness of physical therapy in treating atraumatic full ... Nonoperative treatment using this physical therapy protocol is effective for treating atraumatic full-thickness rotator cuff tears in approximately 75% of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666638324004778

What happens to patients in the long term when we do not ... Conclusion. Nonoperative treatment is an effective and lasting option for many patients with a chronic, full-thickness rotator cuff tear. While some may argue ...

3. sportsmedboston.com sportsmedboston.com/pdf/comparative-time-to-improvement-in-nonoperative-and-operative-treatment-of-rotator-cuff-tears.pdf

comparative-time-to-improvement-in-nonoperative-and- ... Conclusions: Patients undergoing nonoperative treatment had significantly better outcomes in the initial follow-up period compared with patients undergoing a ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2747701

Operative vs Nonoperative Treatment for Atraumatic ... Both nonoperative treatment and surgery are offered to patients with rotator cuff tears, with good outcomes for most patients.

5. jospt.org jospt.org/doi/10.2519/jospt.2025.13182

Rotator Cuff Tendinopathy Diagnosis, Nonsurgical Medical ... Clinicians may use or recommend extracorporeal shock wave therapy to reduce pain and disability in adults with rotator cuff calcific ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11692865/

A Narrative Review of Rotator Cuff Tear Management While surgical treatments generally provide better functional outcomes and pain relief, non-surgical options like physical therapy and corticosteroid ...

7. asipp.org asipp.org/wp-content/uploads/Evidence%E2%80%91based-Management-of-Rotator-Cuf-Tears-Acute-and-Chronic-2022-Current-Physical-Medicine-and-Rehab-Reports.pdf

Evidence-based Management of Rotator Cuff Tears (Acute ... The purpose of this review is to discuss the nonoperative and surgical treatment options that are available for both acute and chronic rotator cuff tears, as ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38182019/

Outcomes of initial nonoperative treatment of traumatic full- ... Rotator cuff repair was performed in 18 patients (45%) following an average of 6 months of nonoperative treatment (range, 3-12 months).

9. binasss.sa.cr binasss.sa.cr/may23/54.pdf

Nonoperative Treatment of Rotator Cuff Tears Rehabilitation or physical therapy has been shown to be an effective conservative treat- ment of rotator cuff tears with best outcomes seen in partial thickness ...