Effectiveness of an Occupation-Based Intervention Compared With Therapeutic Exercise for Older Adults With Shoulder Osteoarthritis: A Pilot Randomized Controlled Trial
Phase: NA
Conditions: Osteoarthritis Shoulder
Sponsor: Bay Path University

BPU-IRB  1/2019 
 
 
 
 
 
 
 
 
 
 
 
 
Effectiveness of an Occupation-Based Intervention Compared with Therapeutic Exercise for 
Older Adults with Shoulder Osteoarthritis: A Pilot Randomized Controlled Trial 
NCT Number: Not Assigned 
Document Date: 10/04/2019 
 
 
 

BPU-IRB  1/2019 
Statistical Analysis Plan (SAP) 
 
Method  
Research Design and Participants  
We conducted a single-center, parallel-group RCT in an outpatient clinic. Participants were 
recruited via convenience sampling from the assisted and independent living facility where the 
outpatient clinic was located. Inclusion criteria were diagnosis of shoulder osteoarthritis and ages 
65 years or older. Diagnosis was confirmed by physician examination or radiographic imaging. 
Exclusion criteria were previous shoulder injuries, acute pathology, previous shoulder surgery, 
current use of pain medication, inflammatory arthritis, upper extremity neuropathy or myopathy, 
current participation in a home exercise program, or a score of <18 on the Mini-Mental State 
Examination (MMSE).  
This study was approved by the Bay Path University Institutional Review Board. All participants 
gave written informed consent to participate. Eighteen older adults were recruited for the study, 
four did not meet the MMSE criteria, and two did not have a confirmed diagnosis of shoulder 
osteoarthritis. Two participants withdrew from the study prior to randomization. Computer-based 
randomization was used to allocate the remaining ten participants into two groups: the Ten 
participants (N = 10) were randomly allocated to the OBI + TE (n = 5) or the TE (n = 5) group.  
Outcomes Measures  
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) (Beaton, Wright, Katz, 
Upper Extremity Collaborative Group, 2005) questionnaire was the primary outcome measure 
and was used to assess the impact of the intervention on physical function and symptoms of 
shoulder osteoarthritis. Scores range from 0 to 100. A lower score indicates less disability. The 
Canadian Occupational Performance Measure (COPM) was used to determine the 

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effect of the intervention on participants’ self-perception of occupational performance and 
satisfaction over time (Law et al., 1990). Shoulder range of motion (ROM) was measured using a 
functional test established by Burner et al. (2014). Active abduction, flexion, external rotation, 
and internal rotation of the shoulder were assessed with participants seated on the edge of a mat 
with no back support and hips and knees at 90 degrees using a 3-point scale for ROM and pain 
(Burner et al., 2014). A Jamar hand dynamometer was used to measure the grip strength of the 
participants (che Daud et al., 2016). Pain was measured using the Numeric Pain Rating Scale 
(NPRS) (Hawker, Mian, Kendzerska, & French, 2011).  
Procedure  
Participants were randomly allocated using a computer-generated random number table. 
Outcome measures were administered prior to the intervention, a week after the conclusion of 
the intervention, and four weeks after the intervention ended. Protocols for occupation-based 
intervention for the treatment of upper extremity musculoskeletal disorders vary widely. 
According to a systematic review by Weinstock-Zlotnick & Mehta (2019), occupation-based 
interventions ranged from 2 to 10 weeks in duration, 1 to 5 sessions per week, with individual 
sessions lasting at least 30 minutes to a maximum of 3 hours. For this study, both groups were 
seen for 60-minute sessions, two times per week, for six weeks. The sessions for the OBI + TE 
group consisted of 30 minutes of TE followed by 30 minutes of OBI. The TE group sessions 
consisted of 60 minutes of TE. All participants received ten minutes of moist heat on the affected 
shoulder as a preparatory activity before the session started.  
Control group. The TE protocol was completed systematically. Passive range of motion 
(PROM), active-assistive range of motion (AAROM), active range of motion (AROM), and  
 

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strengthening activities were completed sequentially. Participants were advised to respect and 
avoid pain with all exercises.  
Intervention group. COPM results were used to select client-centered occupations, collecting 
and placing items in cabinets, washing windows and tables, and hanging clothes on a clothesline, 
for the OBI intervention. To make the activities more meaningful and relevant, interventions 
were completed within a simulated home environment. Participants were encouraged to use the 
affected upper extremity as much as possible, but to respect pain. The same TE protocol as the 
control group was completed prior to OBI, but with fewer repetitions, as a preparatory activity 
for the OBI.  
Data Analysis  
Data was collected and stored in a secure and locked file cabinet to protect the confidentiality of 
the participants. Statistical analyses were conducted using IBM SPSS Statistics (Version 23.0; 
IBM Corp., Armonk, NY). Descriptive statistics for all continuous variables included mean, 
standard deviation, and range. Descriptive statistics for categorical variables included 
frequencies and percentages. Paired sample t-tests were completed for each group for both the 
one week and four week follow up assessments to determine the effectiveness of the treatment 
protocol over time. Three sets of paired t-tests were used to compare the groups to each other at 
baseline, one week posttreatment, and four weeks posttreatment. The statistical significance level 
was set at p < 0.05 (two-tailed). 
 
 

BPU-IRB  1/2019 
Informed Consent Form (ICF) 
 
Title of the Project:  Shoulder Osteoarthritis in the Older Adult: An Occupation-Based 
Treatment Approach 
Principal Investigator: Kelli Cabrera 
University Department: Occupational Therapy 
Faculty Advisor: Rae Ann Smith, OTD, OTR/L, Bay Path University  
 
 
Invitation to be Part of a Research Study 
 
You are invited to participate in a research study. In order to participate, you must have 
a diagnosis of shoulder osteoarthritis, be sixty-five years of age or older, and have the 
ability to understand and respond in English. Taking part in this research project is 
voluntary. 
 
Important Information about the Research Study 
 
Things you should know: 
• The purpose of this study is to determine if a specific set of treatment exercises 
can significantly improve the functional abilities of older adults with shoulder 
osteoarthritis. If you choose to participate, you will be asked to attend a sixty-
minute therapy session two times per week, for a total of six weeks. There will be 
an evaluation the week before the treatment sessions start and another 
evaluation the week after the treatment sessions end. Additionally, there will be a 
final evaluation that occurs four weeks after the conclusion of the therapy 
sessions. The exercise sessions will take place in the Harbor Chase of Mandarin 
therapy gym located on the 3rd floor and the researcher will explain each exercise 
to you. The entire study will take approximately 11 weeks. 
• Risks or discomforts from this research include pain, injury, or aggravation of 
previously existing conditions. Any exercise has risks associated with it and it is 
not always possible to accurately predict your response to a certain exercise. To 
decrease the chance of these risks occurring, you will be asked to respect pain 
and avoid excessive pain with all exercises and activities. 
• The study has the ability to improve your shoulder pain and limited mobility, 
which can improve your overall function and independence.  
• Taking part in this research project is voluntary. You don’t have to participate and 
you can stop at any time. 
Please take the time to read this entire form and ask questions before deciding whether 
to take part in this research project. 
 
 

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What is the study about and why are we doing it? 
 
The purpose of the study is to determine if a standardized treatment approach 
consisting of traditional, therapeutic exercise and occupation-based intervention can 
produce significant functional improvement in older adults with shoulder osteoarthritis. 
Occupation-based intervention is the use of meaningful, purposeful activities as a 
treatment method to restore an individual’s physical functioning and participation in daily 
occupations. At this time, there is no scientific evidence to support the use therapeutic 
exercise and occupation-based intervention in the treatment of shoulder osteoarthritis. 
This researcher is hoping to determine an effective protocol to share with therapists 
worldwide to ensure appropriate treatment of this disorder. 
 
What will happen if you take part in this study? 
 
If you agree to take part in this study, you will be asked to participate in a sixty-minute 
occupational therapy treatment session, twice a week, for six weeks. During these 
treatment sessions, you will complete a variety of exercises and activities to increase 
your shoulder mobility and decrease your pain. Evaluations will occur the week before 
the treatment sessions begin and the week after the treatment sessions end. The final 
evaluation will occur in week ten, or four weeks after the conclusion of the treatment 
sessions. The program will take place at HarborChase of Mandarin in the PT/OT clinic 
located on the third floor.  
 
How could you benefit from this study? 
 
You might benefit from being in this study because you may experience a decrease in 
shoulder pain, an increase in shoulder mobility, and an overall improvement in your 
ability to complete daily tasks. 
 
What risks might result from being in this study? 
 
There are some risks you might experience from being in this study including pain, 
injury, or aggravation of previously existing conditions. To mitigate these risks, we ask 
that you respect pain and avoid excessive pain with all exercises and activities.  
 
How will we protect your information? 
 
We will protect the confidentiality of your research records by storing them in a secure 
and locked file cabinet. Your name and any other information that can directly identify 
you will be stored separately from the data collected as part of the project.  
 
We plan to present and publish the results of this study. To protect your privacy, we will 
not include any information that could directly identify you.  
 
 
 

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What will happen to the information we collect about you after the study is over? 
 
We will keep your research data to use for future research. Your name and other 
information that can directly identify you will be deleted from the research data collected 
as part of the project.  
  
We may share your research data with other investigators without asking for your 
consent again, however it will not contain information that could directly identify you. 
Your research records will be stored in a secure and locked file cabinet only accessible 
to the researcher. 
 
Your Participation in this Study is Voluntary  
 
It is totally up to you to decide to be in this research study. Participating in this study is 
voluntary. Even if you decide to be part of the study now, you may change your mind 
and stop at any time. You do not have to answer any questions you do not want to 
answer. If you decide to withdraw before this study is completed, your data may still be 
used in the research study. It will be protected and stored as described above. Your 
participation may be terminated without consent if you develop an acute shoulder injury 
or demonstrate a change in mental status. 
 
Contact Information for the Study Team and Questions about the Research 
 
If you have questions about this research, you may contact Kelli Cabrera, 
klaramee@baypath.edu, 413-561-6105 or Rae Ann Smith, raesmith@baypath.edu. 
 
Contact Information for Questions about Your Rights as a Research Participant 
 
If you have questions about your rights as a research participant, or wish to obtain 
information, ask questions, or discuss any concerns about this study with someone 
other than the researcher(s), please contact the following: 
 
Bay Path University 
Office of Academic Affairs 
588 Longmeadow Street 
Longmeadow, MA 01106 
Phone: (413) 565-1000 
 
 
Your Consent 
 
By signing this document, you are agreeing to be in this study. By signing this 
document, you are also confirming you are 18 years of age or older. Make sure you 
understand what the study is about before you sign. I will give you a copy of this 
document for your records. I will keep a copy with the study records. If you have any 

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questions about the study after you sign this document, you can contact the study team 
using the information provided above. 
 
I understand what the study is about and my questions so far have been answered. I 
agree to take part in this study.  
 
_________________________________________________ 
Printed Subject Name  
 
_________________________________________________ 
Signature  
 
 
 
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