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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • İstanbul, Turkey
        • Marmara University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: E-learning Group
Participants will enroll in a 4-week e-learning program immediately after completing the pre-intervention assessment measures.
Other: Rotator Cuff Related Shoulder Pain E-Learning Program
The RCRSP e-learning program is designed according to the ADDIE Instructional Design Model in light of current literature.
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.
Other: Rotator Cuff Related Shoulder Pain E-Learning Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Change from baseline test scores at 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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').
Change from baseline self-reported scores at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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