- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04952623
Online Education to Improve the Management of Rotator Cuff Related Shoulder Pain
April 4, 2023 updated by: Marmara University
Randomized Controlled Trial of Online Education for Physiotherapy Students to Improve the Management of Rotator Cuff Related Shoulder Pain
A randomized controlled trial: Conservative treatments including physiotherapy and rehabilitation in the management of rotator cuff-related shoulder pain (RCRSP) are generally accepted as the first-line treatment approach, however, it is known that the disease-specific physiotherapy methods used by physiotherapists are highly variable.
This may be caused by the insufficient knowledge of therapists about evidence-based interventions to RCRSP.
The aim of this study is to develop the '' Rotator Cuff Related Shoulder Pain E-learning Program'' and evaluate its effect on students' knowledge and clinical reasoning skills related to evidence-based RCRSP interventions and their levels of confidence to have this knowledge compared with a control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Shoulder pain is one of society's most common musculoskeletal problems, with a prevalence defined between 16-26%.
Almost 70% of shoulder pain complaints are caused by pathologies associated with the rotator cuff.
Conservative treatments including physiotherapy are widely accepted as a first-line treatment approach in the management of shoulder pain and on the other hand, the variety of physiotherapy practice is conspicuous.
Despite the majority of physiotherapists provide treatment in line with current evidence, passive modalities are still highly preferred by some physiotherapists.
The gap between research evidence and practice could be slightly due to the lack of an up-to-date undergraduate physiotherapy curriculum about the RCRSP.
Therefore, the aim of this study is to develop the '' Rotator Cuff Related Shoulder Pain E-learning Program'' and evaluate its effect on students' knowledge and clinical reasoning skills related to evidence-based RCRSP interventions and their levels of confidence to have this knowledge compared with a control group.
A randomized controlled trial including 146 4th grade physiotherapy students will be conducted.
Students will be randomized into an e-learning group (n=73) or wait-list control group (n=73).
The primary outcome will be the RCRSP achievement test, and the secondary outcome will be the self-reported confidence in knowledge and clinical reasoning skills related to RCRSP.
All data will be collected through an online survey, which will be applied in two different time periods: pre-intervention and post-intervention.
All groups will first answer the questionnaire at the beginning (week 0) and after the study group's e-learning activity (4-5 weeks).
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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İstanbul, Turkey
- Marmara University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 3th or 4th grade physiotherapy students
Exclusion Criteria:
- Students who are not currently enrolled in 3th or 4th grade
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: E-learning Group
Participants will enroll in a 4-week e-learning program immediately after completing the pre-intervention assessment measures.
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The RCRSP e-learning program is designed according to the ADDIE Instructional Design Model in light of current literature.
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Active Comparator: Wait-list Control Group
Participants will enroll in a 4-week e-learning program, 4-5 weeks after completion of the pre-intervention assessment measures.
|
The RCRSP e-learning program is designed according to the ADDIE Instructional Design Model in light of current literature.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rotator cuff related shoulder pain achievement test
Time Frame: Change from baseline test scores at 4 weeks
|
The RCRSP achievement test is consistent with 18 question items with multiple choices.
The mean difficulty and KR-20 reliability coefficient of the test were calculated 0.59 and 0.84, respectively.
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Change from baseline test scores at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported confidence in knowledge and clinical reasoning skills related to rotator cuff related shoulder pain
Time Frame: Change from baseline self-reported scores at 4 weeks
|
The 3-item Questionnaire requires participants to rate their confidence in their knowledge and clinical skills related to RCRSP, using a 5-point Likert Scale ('not at all confident', 'not very confident', 'somewhat confident', 'confident' and 'very confident').
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Change from baseline self-reported scores at 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mine Gülden Polat, PhD., Marmara University
- Principal Investigator: Bahar Ayberk, PhD., Marmara University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2022
Primary Completion (Actual)
February 10, 2023
Study Completion (Actual)
April 3, 2023
Study Registration Dates
First Submitted
June 17, 2021
First Submitted That Met QC Criteria
June 28, 2021
First Posted (Actual)
July 7, 2021
Study Record Updates
Last Update Posted (Actual)
April 6, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16.11.2020.95
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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