Study Stopped
Could not recruit subjects as they routinely chose surgical option
Effectiveness of Manual Therapy and Exercise in Shoulder OA
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2015
CompletedFirst Posted
Study publicly available on registry
October 27, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedSeptember 13, 2019
September 1, 2019
3.1 years
October 20, 2015
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Global Rating of Change
change in rating from baseline to two months
Pittsburgh Sleep Quality Index
change in sleep quality from baseline to two months
Study Arms (2)
Control
NO INTERVENTIONusual medical advice regarding symptomatic control and activity modification
Experimental
EXPERIMENTALSix visits of physical therapy to provide manual therapy and therapeutic exercise
Interventions
application of manual therapy techniques to upper extremity along with therapeutic exercise procedures to the axioscapular and rotator cuff musculature
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- medical co-morbidities (diabetes and rheumatoid arthritis)
- adhesive capsulitis
- fractures
- scapulothoracic paresis
- surgery in past year
- inability to speak English language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 76039, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Patricia Smith, PhD
University of Texas Southwestern Medical Center
- PRINCIPAL INVESTIGATOR
Edward Mulligan, DPT
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2015
First Posted
October 27, 2015
Study Start
May 1, 2016
Primary Completion
June 1, 2019
Study Completion
June 1, 2020
Last Updated
September 13, 2019
Record last verified: 2019-09