Glenohumeral OsteoArthritis Therapy Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical therapy, Home physical therapy.
- Who it may be relevant to
- Registry conditions: Glenohumeral Arthritis, Shoulder Arthritis Osteoarthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Randomized Trial Comparing Physical Therapy or Home Exercise With No Treatment for Patients With Glenohumeral Osteoarthritis
Overview
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.
Interventions
- Behavioral Physical therapy
12 weeks of designated physical therapy focused on improving shoulder strength and range of motion - Behavioral Home physical therapy
12 weeks of home therapy program focused on improving shoulder strength and range of motion
Primary outcome measures
- Visual analog scale (VAS) [Time frame: Time 0, 6 weeks, 12 weeks, 1 year]
- American Shoulder and Elbow Surgeons (ASES) [Time frame: Time 0, 6 weeks, 12 weeks, 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UBMD Orthopaedics & Sports Medicine — Buffalo
Identifiers
NCT: NCT07744542 · IRB ID: STUDY00009760