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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04952623
Other study ID # 16.11.2020.95
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2022
Est. completion date April 3, 2023

Study information

Verified date October 2022
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date April 3, 2023
Est. primary completion date February 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 3th or 4th grade physiotherapy students Exclusion Criteria: - Students who are not currently enrolled in 3th or 4th grade

Study Design


Intervention

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.

Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rotator cuff related shoulder pain achievement test 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 Self-reported confidence in knowledge and clinical reasoning skills related to rotator cuff related shoulder pain 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
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