Effectiveness of Manual Therapy and Exercise in Shoulder OA

This study will be a pragmatic, prospective, single blind, randomized controlled trial.
Stratified randomization will be performed to account for those patients that necessitate a
subacromial corticosteroid injection prior to or during the physical therapy intervention.
The diagnosis of primary glenohumeral osteoarthritis will be confirmed by the orthopedic
surgeon involved in the study. All subjects will have radiographs at the time of initial
evaluation (standard medical practice) and magnetic resonance imaging will only be required
at the discretion of the orthopedic surgeon when this modality is necessary to rule out other
shoulder pathologies of concern.

This study will use a convenient sample of consecutive subjects who meet all inclusion
criteria and present to the shoulder service physicians at UT Southwestern outpatient clinic
with a primary compliant of shoulder pain and stiffness. If appropriate for the study, the
subjects will be referred to physical therapy for additional assessment and care. If
interested in participation, each potential subject will be educated regarding the purpose
and logistics of the study and asked to enroll via informed consent.

Approximately 25 of the 50 subjects will be seen in the clinic for 6 visits within a 4 week
time frame. All subjects will return for follow-up or phone call at 4, 8, and 52 weeks for
final data collection and outcomes assessment. The last follow-up assessment at one year will
be via phone contact. For those attending physical therapy, the duration of the visits, 1-6,
will last from 30-60 min. The final visit, visit 9, will take 15-30 minutes. The phone call
on the tenth interaction will last 5-10 minutes.

Session 1: Participant Enrollment - Obtainment of consent, HIPPA and health screen. Baseline
dependent variable data will be collection and the subjects will be randomly allocated to one
of the treatment groups. One group will receive usual medical advice including tips on
posture, activity modifications, and symptom control. The other group will initiate the
program of physical therapy outlined below. Subjects allocated to the physical therapy
treatment arm will proceed to a standard physical therapy visit in which they will be
instructed in the initial exercise training and educated on the use exercise log for
assessment of compliance.

Session 2-6 (within 4 weeks after session 1): All patients in the experimental group will
receive standardized physical therapy intervention to treat shoulder osteoarthritis including
manual therapy (no more than 2 units, <37 minutes) and standard flexibility and range of
motion exercises. Patient's will also undergo an in clinic assessment of compliance of their
exercise program and appropriate progression of the shoulder strengthening exercises will be
provided. Patients in the control group will not participate in sessions 2-5.

Independent Variable:

Group 1 Intervention- manual physical therapy and strengthening exercises to the entire upper
quarter, flexibility exercises, range of motion exercises, and usual medical advice.

Manual Therapy: joint mobilization to anterior, posterior, and inferior capsule as indicated
at discretion of treating physical therapist

Shoulder Exercise Training:

1. Adducted ER with towel roll in sitting or standing ("no-money" exercise with concurrent
external rotation)

2. Supine or standing boxer punch for serratus

3. Short arc military press progressing to flexion or scaption as tolerated

4. Subscapularis isolation via seated narrow grip internal rotation row

5. Horizontal abduction in neutral (wide grip rows)

- Compliance to the home exercise program will be assessed using a daily log.

- All therapeutic exercises with include theraband resistance performed 2-3x20/daily

Session 6 (4 weeks after Session 1): Post-Intervention Data Collection and finalization of
the exercise training and self-mobilization protocol for the experimental group. The control
group will return for a repeat of baseline testing.

Session 7 (8 weeks after Session 1): Post-Intervention Data Collection - Re-assessment of
dependent variables.

Session 8 (one year after enrollment): Phone call to collect outcome assessment data

Dependent Variables:

Primary

1. Numerical pain rating scale at baseline day 28, day 56, and day 365 during scapular
plane shoulder elevation

2. Functional Outcome Score: American Shoulder and Elbow Surgeon scale (ASES) questionnaire
and Simple Shoulder Test (SST)

Secondary

1. Patient's Global Rating of Change (15 point ordinal scale ranging from -7 to +7)

2. Patient self-reported global percentage of improvement (0-100%)

3. Tampa Scale for Kinesiophobia score

4. Pittsburgh Sleep Quality Index score

5. Internal and External Rotation Range of Motion

6. Scapular Elevation strength via manual muscle test

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