Osteoarthritis Clinical Trial
Official title:
Effectiveness of Manual Therapy and Exercise in the Management of Glenohumeral Osteoarthritis: A Randomized Controlled Trial
NCT number | NCT02587559 |
Other study ID # | 042015-091 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | June 2020 |
Verified date | September 2019 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Approximately 60 subjects from a sample of convenience diagnosed with shoulder arthritis will be randomized into a two groups. The control group will receive usual medical advice and the experimental group will be referred to physical therapy for eight visits over 4-week period of time. At one month, two months, and one year the pain, function, and patient satisfaction will be compared between the two groups.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2020 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: - over 50 years of age - Osteoarthritis > Grade 3 on the Kellgren-Lawrence scale - Presence of at least two of the following findings: - morning stiffness that resolves within 60 minutes - pain > 3/10 on a numerical pain rating scale - asymmetrical mobility in either contralateral elevation and/or glenohumeral rotation, or notable crepitus with active motion. Exclusion Criteria: - medical co-morbidities (diabetes and rheumatoid arthritis) - adhesive capsulitis - fractures - scapulothoracic paresis - surgery in past year - inability to speak English language |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Level Change | self-report outcome score via American Shoulder Elbow Surgeon's scale and Simple Shoulder Test | change in function from baseline to two months | |
Secondary | Global Rating of Change | scale of patient satisfaction | change in rating from baseline to two months | |
Secondary | Pittsburgh Sleep Quality Index | sleep quality assessment | change in sleep quality from baseline to two months |
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