Glenohumeral OsteoArthritis Therapy Trial (GOAT)

University at Buffalo (UB)

Status: Invitation-only

Conditions: Shoulder Arthritis Osteoarthritis; Glenohumeral Arthritis

Treatments: Behavioral: Physical therapy; Behavioral: Home physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07744542

IRB ID: STUDY00009760

Details and patient eligibility

About

Arthritis of the shoulder glenohumeral joint is a growing problem in an aging population. Treatment options for glenohumeral arthritis can be grouped into three main categories: 1) shoulder replacement surgery, 2) injections (corticosteroid, hyaluronic acid and PRP) and physical therapy (PT). Surgery comes with risks and the potential for implant failure or revision over time. Therefore, it is typical for doctors to prescribe injections and/or PT before discussing surgery. Sometimes, insurance companies will require PT before considering a shoulder operation. It is unknown if PT is effective for improving function or pain with patients with glenohumeral arthritis. The aim of this study is to compare pain and functional outcomes after undergoing a 12 week PT program, at home PT exercises or delaying conservative treatment.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient diagnosed with glenohumeral arthritis
• Patient > 18 years of age (adults)
• Patient provided written informed consent for study participation with IRB approved consent form
• Patient is willing and able to comply with scheduled clinical and radiographic evaluations and physical therapy regimen

Exclusion criteria

• -Have had corticosteroid injections in the affected shoulder(s) within 6 weeks of starting physical therapy.
• Those that have glenohumeral arthritis that is inflammatory, post traumatic or related to rotator cuff tear arthropathy in nature
• Have avascular necrosis of the glenohumeral joint
• Have failed a course of 6 weeks of physical therapy within the last year
• Have had surgery on the symptomatic shoulder in the past year
• Daily use of opioid (excluding tramadol or codeine).
• Have dementia
• Currently in a physical therapy program for more than 2 weeks
• Have planned total shoulder arthroplasty in the next 6 months.
• Live in a nursing home
• Additionally special populations listed below such as pregnant women, and prisoners will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 3 patient groups

Physical Therapy

Experimental group

Description:

12 weeks of designated physical therapy focused on improving shoulder strength and range of motion

Treatment:

Behavioral: Physical therapy

Home Therapy

Experimental group

Description:

12 weeks of home therapy program focused on improving shoulder strength and range of motion

Treatment:

Behavioral: Home physical therapy

Control Group

No Intervention group

Description:

Subjects continue with coping mechanisms for 12 week period, no intervention