Rehabilitation for Shoulder Osteoarthritis

(RTSA Trial)

Overseen By Megan Reams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Must not be taking: Anticoagulants

Disqualifiers: Rheumatoid arthritis, Gout, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to aid recovery after reverse total shoulder arthroplasty (RTSA), a shoulder surgery often used when other treatments fail. The study compares immediate active shoulder rehabilitation, where patients begin moving their shoulder soon after surgery, with traditional rehabilitation, where movement progresses more gradually. The goal is to determine which method results in better outcomes, fewer complications, and lower costs over a year. Suitable candidates for this trial typically require a primary reverse total shoulder arthroplasty and can complete follow-up tasks, but should not have had previous shoulder surgeries or certain other health conditions. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance recovery methods for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners), you must stop taking them at least 10 days before surgery.

What prior data suggests that this rehabilitation method is safe for shoulder osteoarthritis?

Research has shown that therapies like physical and occupational therapy are generally safe for shoulder arthritis and similar conditions. Starting shoulder movement soon after surgery, such as with Immediate Active Shoulder Rehabilitation (IASR), is also considered safe. Studies have found no significant increase in problems when shoulder movement begins earlier. Patients can start moving their shoulders early without extra risk, which might aid in recovery. Overall, the safety evidence is promising for those considering joining a trial with this type of rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing traditional shoulder rehabilitation to immediate active shoulder rehabilitation for osteoarthritis because it explores the timing and method of therapy. Unlike the standard approach, which often involves a gradual increase in activity, the immediate active method seeks to engage shoulder function right away, potentially leading to faster recovery and improved joint function. This trial could reveal whether jumping into active rehabilitation sooner is more beneficial than the traditional, more cautious methods. If successful, this could reshape how physical therapy is approached for shoulder osteoarthritis, offering patients a quicker path to relief.

What evidence suggests that this trial's rehabilitation treatments could be effective for shoulder osteoarthritis?

Research shows that people who start moving their shoulders soon after surgery often recover well. In this trial, participants will follow different rehabilitation approaches. Some will receive Immediate Active Shoulder Rehabilitation, which some studies suggest helps reduce shoulder pain and improve function shortly after surgery. In those studies, patients experienced no negative effects from early shoulder movements and returned to work faster, typically around 2 months after surgery. This approach might lead to better outcomes for people undergoing shoulder surgery. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 55 or older who need a primary reverse total shoulder arthroplasty, can fill out questionnaires themselves, and speak English. They must be able to attend follow-up visits and give informed consent. Exclusions include prior shoulder surgeries, infections, bleeding disorders, uncontrolled diabetes (HbA1C > 7.5%), major illnesses with life expectancy under 2 years, tobacco use within the last 8 weeks, drug/alcohol abuse.

Inclusion Criteria

I can fill out questionnaires by myself.

Able and willing to give informed consent

I am 55 years old or older.

Exclusion Criteria

I have a shoulder socket fracture caused during surgery.

I am undergoing or have undergone a shoulder procedure.

I have had complications from shoulder replacement surgery.

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 followed by either immediate active shoulder rehabilitation or traditional rehabilitation

Varies

Multiple visits for rehabilitation

Follow-up

Participants are monitored for clinical outcomes, complications, and cost effectiveness

1 year

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Rehabilitation

Trial Overview The study tests immediate active shoulder rehabilitation versus traditional post-operative rehab after reverse total shoulder arthroplasty. It aims to compare clinical outcomes like pain relief and range of motion improvements as well as complications and cost-effectiveness over one year.

How Is the Trial Designed?

Group I: Immediate Active Shoulder Rehabilitation Experimental Treatment 1 Intervention

Group II: Traditional Should Rehabilitation Active Control 1 Intervention

Rehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Rehabilitation for:

• Complex Regional Pain Syndrome (CRPS)
• Musculoskeletal disorders
• Neurological conditions

Approved in United States as Rehabilitation for:

• Complex Regional Pain Syndrome (CRPS)
• Chronic pain management
• Physical disabilities

Approved in Canada as Rehabilitation for:

• Complex Regional Pain Syndrome (CRPS)
• Musculoskeletal injuries
• Neurological rehabilitation

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

TRIA Orthopaedic Center

Collaborator

Trials

4

Recruited

1,000+

Published Research Related to This Trial

In a systematic review of 17 studies involving 1292 patients, it was found that 26% of patients developed osteoarthritis (OA) in the glenohumeral joint at a minimum of 5 years after undergoing rotator cuff repair (RCR).

Patients who required revision surgery due to retears had a higher incidence of OA at 29%, indicating that surgical outcomes and patient demographics may influence the risk of developing OA post-operatively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for the development of degenerative changes among patients undergoing rotator cuff repair: A systematic review. Macciacchera, M., Siddiqui, S., Ravichandiran, K., et al.[2023]

Conservative treatments for glenohumeral osteoarthritis, such as oral anti-inflammatory medications and cortisone injections, can help manage pain and improve function, but advanced joint destruction may necessitate surgical intervention.

Successful postoperative rehabilitation relies on effective communication and collaboration among the physician, therapist, and patient, with each member playing a crucial role in achieving optimal recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteoarthritis and traumatic arthritis of the shoulder. Kelley, MJ., Ramsey, ML.[2019]

Shoulder arthroplasty has significantly improved clinical outcomes for shoulder disorders, aided by advancements in surgical techniques and imaging methods for pre-operative planning and post-operative monitoring.

Recent developments in imaging, such as improved plain radiographs and new CT scan techniques, enhance the ability to detect complications like component loosening in shoulder prostheses, which is crucial given the rising number of shoulder arthroplasties performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shoulder Arthroplasty Imaging: What's New. Gregory, TM., Gregory, J., Nicolas, E., et al.[2022]

This study is a randomized controlled trial comparing total shoulder arthroplasty (TSA) followed by rehabilitation to a 12-week exercise program for patients with glenohumeral osteoarthritis, involving 102 participants and expected to conclude by March 2024.

The primary outcome will assess quality of life 12 months post-treatment, with secondary outcomes including pain intensity and functional scores, providing a comprehensive evaluation of the effectiveness of surgical versus non-surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial. Beck Larsen, J., Thillemann, TM., Launonen, AP., et al.[2023]

Only one study out of 506 reviewed provided moderate evidence that early physical therapy after total shoulder arthroplasty can lead to quicker improvements in function and pain relief.

There is a significant gap in research regarding the effectiveness of physical therapy for reverse total shoulder arthroplasty, highlighting the need for more high-quality studies to guide rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of formal physical therapy following total shoulder arthroplasty: A systematic review. Edwards, PK., Ebert, JR., Littlewood, C., et al.[2022]

A systematic review of 76 studies found strong evidence that range of motion (ROM) exercises, strengthening exercises, and joint mobilizations effectively improve function and reduce pain in individuals with shoulder musculoskeletal disorders.

The effectiveness of physical modalities varies and is considered moderate to mixed, indicating that while some may be beneficial, their impact depends on the specific shoulder disorder being treated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Occupational Therapy Interventions for Musculoskeletal Shoulder Conditions: A Systematic Review. Marik, TL., Roll, SC.[2022]

Shoulder arthroplasty is an effective treatment for patients with advanced shoulder osteoarthritis, providing significant relief from pain and improved function.

This case report presents the first instance in Thailand of a patient with primary glenohumeral osteoarthritis successfully treated with humeral head surface arthroplasty, highlighting its potential as a viable surgical option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Humeral head surface arthroplasty: a case report. Luenam, S., Kosiyatrakul, A., Chotanaphuti, T., et al.[2016]

The study assessed the effectiveness of a publicly available risk calculator for predicting successful outpatient total shoulder arthroplasty (TSA) discharge, finding it performed similarly to chance, indicating limited utility in clinical decision-making.

Despite the risk calculator's ineffectiveness, the study showed that outpatient TSA had low complication rates (2.6%) and no significant differences in readmissions or reoperations compared to inpatient procedures, suggesting outpatient TSA can be safely performed in selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting successful outpatient total shoulder arthroplasty. Leape, CP., Donaldson, ST., Haislup, BD., et al.[2023]

There is currently no definitive optimal method for measuring outcomes in patients undergoing shoulder arthroplasty, highlighting the need for a comprehensive approach that includes general health, shoulder-specific assessments, and disease-specific evaluations.

The article provides valuable recommendations and calculations for assessing shoulder elevation in arthroplasty patients, which can help improve the evaluation process for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of outcome in shoulder arthroplasty. Kuhn, JE., Blasier, RB.[2019]

A systematic review of six randomized controlled trials involving 368 patients found that telerehabilitation for shoulder pain shows no significant difference in effectiveness compared to in-person physical therapy or home-based exercise programs.

However, telerehabilitation was found to be more effective than providing advice alone, significantly improving both shoulder pain and disability, although the overall evidence quality was very low to low, indicating caution in making strong recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical therapy given by telerehabilitation on pain and disability of individuals with shoulder pain: A systematic review. Gava, V., Ribeiro, LP., Barreto, RPG., et al.[2022]

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]

A survey of 607 Italian physiotherapists revealed that their rehabilitation practices for Total Shoulder Arthroplasty (TSA) and Reverse Total Shoulder Arthroplasty (RTSA) largely align with current literature, particularly in focusing on strengthening key muscle groups and preventing dislocation-related movements.

However, notable differences were found in how physiotherapists approach the restoration of active and passive range of motion, as well as the timing and progression of muscle strengthening exercises, indicating variability in clinical practice that reflects ongoing developments in rehabilitation knowledge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation following shoulder arthroplasty: a survey of current clinical practice patterns of Italian physiotherapists. Brindisino, F., Lorusso, M., Usai, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8807994/

Effectiveness of early versus delayed rehabilitation ... There is very low-quality evidence that early rehabilitation may improve shoulder pain and function in the early post-operative phase following anatomic total ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965055/

Rehabilitation and Long Term Outcomes Including Return ... In data collected from 12 studies, patients returned to work an average of 2.3 ± 2.4 months after rTSA and 1.93 ± 3.74 months after aTSA.

3. jospt.org jospt.org/doi/10.2519/jospt.2021.9634

Move It or Lose It? The Effect of Early Active Movement on ... There were no adverse effects associated with early active shoulder movement. However, results are based on mostly moderate-certainty evidence.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666638324003815

Effectiveness of nonoperative treatment in patients with ... 30% of patients with GHOA who chose their nonoperative treatment regimen had clinically meaningful improvements in symptoms.

5. withpower.com withpower.com/trial/phase-osteoarthritis-11-2018-47b05

Rehabilitation for Shoulder Osteoarthritis (RTSA Trial) It aims to compare clinical outcomes like pain relief and range of motion improvements as well as complications and cost-effectiveness over one year.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10256270/

Physical Therapist Management of Glenohumeral Joint ... The Western Ontario Osteoarthritis Score (WOOS) Shoulder Index is a specifically designed outcome measure to assess symptoms, function/disability, and emotions ...

7. esskajournals.onlinelibrary.wiley.com esskajournals.onlinelibrary.wiley.com/doi/10.1002/jeo2.70449

Early mobilisation versus delayed protocols after reverse total ... Recent studies suggest that earlier initiation of motion, or even direct active rehabilitation, may be safe and effective. Kornuijt et al.